Transcelerate Clinical Qms Assessment Tool: Abbreviations and Acronyms

TransCelerate Clinical QMS Asse
Name:
Foundational Aspect #1: Understand the Context
Foundational Aspect #2: Leadership Commitment to Quality
Foundational Aspect #3: Organizational Commitment to Quality

Foundational Aspect #4: Continuous Improvement
Element #1: Process
Element #2: Resources, Roles, and Responsibilities
Element #3: Partnering
Element #4: Risk Management
Element #5: Issue Management (IM)
Element #6: Knowledge Management*
Element #7: Documentation Supporting Achievement of Quality
Element #8: Assessing a Clinical QMS
Element #9: Management Review
Abbreviations and Acronyms
CLINICAL QMS Clinical Quality Management System
QMS Quality Management System
RACI Responsible, Accountable, Consult, Inform

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Version: 6.1
Date: 09-Aug-2017
Created by: Jonathan Batugo Paras (Amgen Inc.)
QMS Assessment Tool
Definition
A quality management system tailored for the conduct of clinical

development activities
N/A
A matrix of activities and/or decision making authorities

undertaken by an organization in relation to the roles and
responsibilities.
ors and others with regards to risk-based monitoring methodologies. Each clinical trial
responsibility for its own risk assessment process and accompanying materials to ensure
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ord of CQMS .
al assessment visual as is therefore not recommended.
Status Overview: Quality Management System
Overall Clinical QMS Status Individ
[Foundational Aspect #1:

Understand the Context]

Leadership Commitment to
Quality]
132; 100%

Organizational Commitment to
Quality]
Rating Legend
0
Continuous Improvement]
1
Printed on: 10:55:45 07/20/2020

Summary: All categories Summary: Per category
Rating = 0 132
Rating = 1 0
Rating = 2 0
Rating = 3 0
# of items with # of items with
Category
(Rating = 3) (Rating = 2)
F1.1. 0 0
F1.2. 0 0
F1.3. 0 0
F1.4. 0 0
F1.5. 0 0
F1.6. 0 0
F1.7. 0 0
0 0
F2.1. 0 0
F2.2. 0 0
F2.3. 0 0
F2.4. 0 0
F2.5. 0 0
0 0
F3.1. 0 0
0 0
F4.1. 0 0
F4.2. 0 0
0 0
1.1. 0 0
1.2. 0 0
1.3. 0 0
1.4. 0 0
1.5. 0 0
1.6. 0 0
1.7. 0 0
1.8. 0 0
1.9. 0 0
1.10. 0 0
1.11. 0 0
1.12. 0 0
1.13. 0 0
0 0
2.1. 0 0
2.2. 0 0
2.3. 0 0
2.4. 0 0
2.5. 0 0
2.6. 0 0
0 0
3.1. 0 0
3.2. 0 0
3.3. 0 0
3.4. 0 0
3.5. 0 0
3.6. 0 0
3.7. 0 0
0 0
4.1. 0 0
4.2. 0 0
4.3. 0 0
4.4. 0 0
4.5. 0 0
4.6. 0 0
0 0
5.1. 0 0
5.2. 0 0
5.3. 0 0
5.4. 0 0
5.5. 0 0
5.6. 0 0
5.7. 0 0
5.8. 0 0
5.9. 0 0
5.10. 0 0
0 0
6.1. 0 0
6.2. 0 0
6.3. 0 0
6.4. 0 0
6.5. 0 0
0 0
7.1. 0 0
7.2. 0 0
0 0
8.1. 0 0
8.2. 0 0
8.3. 0 0
8.4. 0 0
0 0
9.1. 0 0
9.2. 0 0
0 0
ry: Per category
# of items with # of items with

(Rating = 1) (Rating = 0)
0 2
0 3
0 2
0 2
0 2
0 2
0 2
0 15
0 2
0 1
0 3
0 2
0 1
0 9
0 2
0 2
0 2
0 1
0 3
0 3
0 1
0 1
0 2
0 1
0 1
0 3
0 1
0 1
0 6
0 1
0 1
0 3
0 25
0 2
0 2
0 2
0 2
0 3
0 1
0 12
0 0
0 2
0 1
0 2
0 1
0 3
0 2
0 11
0 3
0 1
0 4
0 2
0 2
0 4
0 16
0 3
0 1
0 1
0 2
0 2
0 1
0 2
0 2
0 2
0 2
0 18
0 1
0 2
0 2
0 1
0 1
0 7
0 2
0 2
0 4
0 2
0 1
0 1
0 1
0 5
0 2
0 3
0 5
Foundational Aspect #1: Understand the Context
Statement from Clinical QMS Concept Paper
F1.1. To develop an effective and efficient clinical

QMS, the organization should evaluate and
understand the external and internal
environment in which it operates. This
evaluation will permit tailored development,
refinement, and implementation of an
organization’s clinical QMS based on the unique
aspects of the organization.”
F1.2. An understanding of the organization’s

customers and other stakeholders and their
requirements related to quality will shape the
design of a clinical QMS. The range of external
stakeholders for a clinical QMS can be broad,
given the complex nature of clinical
development. Each organization should define
the perspectives of key stakeholders for their
clinical development activities and perform an
assessment of their views. This information will
inform not only the clinical QMS design but the
manner and cadence of engagement of these
stakeholders, as applicable”
F1.3. The organization should monitor for new or
evolving legislation, regulations, and/or
guidance and other significant changes in the
external environment relevant to its activities
and its partners.
F1.4. Consideration should be given to how a clinical

QMS will align with strategic objectives, as a
clinical QMS framework should support their
achievement while maintaining compliance with
applicable regulatory requirements.
F1.5. A clinical QMS should be tailored and integrated
within the governance structure, with flexibility
to account for changes in governance. In turn,
the governance structure should support the
clinical QMS."
F1.6. The organization should critically assess the
current culture and value drivers within the
organization to understand the extent to which
these may support or hinder an effective clinical
QMS. Attention should be given to proactively
addressing any cultural challenges that may
impede
effective and efficient design and sustained
implementation of a clinical QMS.”
F1.7. The organization should consult with the range

of internal stakeholders who may impact, be
impacted by, or perceive that they are impacted
by a clinical QMS and/or the quality of clinical
development.”
Rating Average
Interview/Survey Question(s)
(0, 1, 2, 3) Rating
F1.1a Does the company evaluate and understand

the impact of the external environment in which it
operates, including regulatory environment, industry
standards, geographical, and geopolitical impacts?
F1.1b Does the company understand its own 0.0

internal environment regarding structure, limitations,
culture, tolerance for risks?
F1.2a Has the organization defined key customers

and stakeholders?
0
F1.2b Has the organization communicated with their

stakeholders and customers to gain insight into their
“critical to quality” perspective? 0 0.0
F1.2c Is this feedback assessed?
0
F1.3a Is there a process in place for identifying
evolving legislation, regulations, guidance,
significant changes in the regulatory/external
environment?
F1.3b Are procedural documents updated and 0.0

implemented in a timely manner to reflect
new/changing regulation, and communication of the
information as necessary?
F1.4a Are the clinical QMS elements identified and

do they support your strategic objectives?
0.0
F1.4b Is the clinical QMS designed based on
relevant regulations to ensure they are met?
0.0
F1.5a Has the clinical QMS been integrated with the

existing governance structure?
0.0
F1.5b Is the clinical QMS flexible enough to allow for
changes in the existing governance structure?
0
F1.6a. Does the organization have a clear
understanding of its culture and how the culture
impacts the effectiveness of its clinical QMS?
0.0
F1.6b Are the values that drive quality clearly and
consistently understood on all levels throughout the
organization?
F1.7a Is a process in place to ensure all relevant

stakeholders at all levels are consulted and/or
informed on issues/activities that impact them?
0
0.0
F1.7b Is it ensured that the responsibilities are
communicated to all affected stakeholders?
0
Contextual Considerations
(to be used in support of the evaluation – not to be rated)
Does the organization define, document and communicate the external

environment in which it operates, the context and regulations impacting the
company? For example, the number of countries, regions, therapeutic areas,
drug or product types such as drug delivery devices, product life cycles,
market stability, applicable health authorities and associated regulations, etc.
How does the organization identify the roles/functions impacted by the

changes to regulations, legislation, etc. to ensure awareness and compliance
of these changes?
Does the organization define, document and communicate the internal

environment in which it operates, the context and regulations impacting the
company? For example, is it effective across the organization, across
functions, across processes, aspects of work that are contracted out, re-
organizations, acquisitions and licensing agreements, interdependencies of
the functions, etc.
Has the organization’s size, complexity, approach to risk, level of commitment

to quality been taken into consideration in the design of the clinical QMS?
Consider how to identify stakeholders and customers and the feedback loop to
assess their critical to quality perspective.
Consider how the organization approaches key customers and stakeholders.

For example, does the organization take a narrow, possibly basic, approach
that includes customer stakeholders, investigational sites, and internal
stakeholders; or does it take a broader view including customer partners,
vendors, supply chain, its own vendors supporting customer work, patients,
other recipients of work product, etc.
Is the identification process continuous, periodic, ad hoc? Once identified, how
is the information communicated across directly and indirectly impacted parts
of the organization?
Is the relevant reference knowledge/information retained centrally and

accessible on demand?
Is the impact to current company policies and procedures assessed, and is

there agreement within the company on the approach, and implementation?
Are regulations interpreted and a company policy or standing established in
alignment with regulations?
Are findings from prior inspections considered to ensure regulatory

expectations can be achieved?
Timeliness of updates should be in conformance with company procedures.
Are changes relevant to partners communicated?
Is the clinical QMS designed considering the organization’s strategic

objectives so that the strategic objectives can be met without deviating from
regulatory requirements?
Have the regulations been routinely reviewed to identify what to focus on for
the organization’s strategic objectives and ensure they are fit-for-purpose?
Have the elements been defined, are they clear, do they have ownership, are
they measured to ensure compliance?
How does the organization ensure that the clinical QMS is enabling the
strategic objectives?
Are the strategic objectives communicated with the organization?
Do employees demonstrate an understanding of the organization’s strategic

objectives?
Is the achievement of the objectives monitored? How does the organization

ensure that the clinical QMS is allowing the company to maintain compliance?
Does the clinical QMS design consider and support the company’s broader
quality paradigm?
Are strategic objectives developed to ensure quality is integrated into day to

day work in support of a quality culture?
How does the organization ensure that the clinical QMS is enabling the
strategic objectives?
Are the strategic objectives communicated with the organization?
Do employees demonstrate an understanding of the organization’s strategic

objectives?
Is the achievement of the objectives monitored? How does the organization

ensure that the clinical QMS is allowing the company to maintain compliance?
Does the clinical QMS design consider and support the company’s broader
quality paradigm?
Are strategic objectives developed to ensure quality is integrated into day to

day work in support of a quality culture?
The governance structure includes any structure for managing oversight of the
organization.
Is the size and complexity of the organization taken into consideration?
Does the governance team consist of members from all involved functions?
Is flexibility incorporated into the clinical QMS to allow for changes in

governance?
Does the governance structure support swift and transparent decision

making?
Is the governance structure designed to avoid development of silos?
Does the organization’s governance structure support and reflect the clinical
QMS?
Does the organization’s issue escalation process include members of the

governance team?
Does the organization’s culture support a commitment to quality?
How does the organization’s leadership communicate and exhibit a

commitment to quality?
Does the organization foster an environment that encourages communication

of quality issues at all levels without fear of retaliation?
Does the organization actively address issues with a purpose to learn from
them?
How are cultural challenges addressed to avoid an impact on the

effectiveness, efficiency and sustainability of the CLINICAL QMS?
How are continuous improvement opportunities to the CLINICAL QMS

received and actioned?
How does the culture encourage timely resolution of issues that matter?
How does that compare to the way other, non-quality related objectives, are
managed?
Does the organization define responsibilities to ensure that all relevant parties,
both ‘official’ stakeholders (e.g., management, impacted staff) and individuals
who perceive an impact on their processes/activities, are appropriately
involved in decisions around the clinical QMS and the quality in clinical
development?
Does the organization have a process that ensures all relevant stakeholders,
internal and external to the clinical organization, whether active (actively
involved or impacted) or passive (consulted or informed) are engaged in
discussions, decisions around the clinical QMS and the quality in clinical
development?
Foundational Aspect #2: Leadership Commitment to Quality
F2.1. An organization’s senior leadership is

accountable and responsible for defining and
documenting expectations for quality and
communicating the importance of quality to the
organization. This message should be
consistent, credible, and tangible, such that
each individual understands how quality applies
to him/her and other stakeholders.”
F2.2. Leaders at all levels should visibly support this
message and emphasize the importance of a
collaborative approach to quality. Leaders
should communicate that a quality function is an
enabling function, to support and advise the
business, not the function wholly responsible for
ensuring quality.
F2.3. An organization’s senior leadership should have

ongoing insight into the effectiveness and
efficiency of its clinical QMS as well as a holistic
view of the status of significant quality risks and
issues. These senior leaders are accountable
and responsible for defining the overall risk
attitude of the organization and verifying that
decisions to accept, avoid, mitigate, or transfer
significant risks are aligned.
F2.4. Senior leaders may delegate their responsibility
for ongoing management oversight. However,
these leaders retain accountability and should
ensure that staff members to whom these
responsibilities are delegated have the
appropriate authority, competence and
resources to carry them out effectively.
F2.5. Finally, given the dynamic nature of clinical

development and the ongoing evolution of
health authority requirements for quality, senior
leadership should periodically review quality
expectations and update them, as appropriate,
to ensure stakeholder needs and requirements
continue to be met.
t to Quality
Rating Average
(0, 1, 2, 3) Rating
F2.1a Does senior leadership actively and regularly

communicate their commitment to quality and
expectations to the organization?
0.0
F2.1b How does senior leadership communicate a
consistent, credible and tangible commitment to
quality?
0
F2.2a Do the organization’s leaders promote the
concept that quality is a shared responsibility,
owned by all?
0 0.0
F2.3a Does senior leadership execute oversight of

the clinical QMS and quality?
F2.3b How does senior leadership demonstrate the

expectations for overall risk attitude and is it clearly
communicated and understood by the organization?
0 0.0
F2.3c Is there alignment at all levels of the

organization for the acceptance of risk?
0
F2.4a Do senior leaders demonstrate retaining
accountability when delegating responsibility for
quality oversight?
0.0
F2.4b Is appropriate authority and competence
confirmed when delegating oversight
responsibilities?
F2.5a Is there a process for senior leadership to

periodically review the organization’s quality
expectations for alignment with regulatory
requirements and ensure updating as appropriate to
meet stakeholder needs?
0 0.0
How does senior leadership demonstrate their commitment to quality?
Are expectations defined, documented and communicated by senior

leadership (i.e., does senior leadership assume accountability for quality) to
the organization?
How is senior leadership held accountable for quality?
Does senior leadership include consideration for quality objectives in decision-

making?
How does senior leadership incorporate quality considerations in

communications to the organization?
Are quality objectives included in the individual objectives for senior leaders?
Does senior leadership understand the impact of the ‘cost of quality/poor

quality’ on the organization?
How are the messages from and actions of senior leadership perceived by the
organization?
Does senior leadership espouse to a quality culture?
Does senior leadership emphasize the importance of quality to meeting the

organization’s strategic objectives in communications and decisions related to
quality?
How do leaders demonstrate behaviors that support a quality approach
including: visible quality advocacy, modeling desired behaviors to shape and
reinforce a culture of quality, assuring sufficient resources and availability of
adequately trained staff?
How is the collaborative approach to quality promoted and rewarded?
Do leaders demonstrate and communicate ownership of quality belongs to

everyone in the organization (i.e., quality is not owned by the Quality
organization alone)?
Do leaders within the organization promote the concept that Quality

department serves as an advisor to the business on quality owning the actions
for ensuring quality?
Are leaders being measured on their promotion of quality as a shared

responsibility and how are they being measured? Is the measurement tied to a
motivating factor (i.e. performance reviews, rewards)?
How does senior leadership ensure insight into the effectiveness and
efficiencies of the clinical QMS?
How are senior leaders informed of significant issues / risks?
Does the organization have a defined process for issue escalation that
includes senior leadership notification?
Does the process for issue escalation include, where applicable, action and
decision by senior leadership?
Does the organization have a defined, documented process for issue

escalation that includes senior leadership accountability?
What, if any tools are provided to allow for appropriate judgment-based risk
decisions?
How do senior leaders demonstrate retention of accountability when
delegating quality responsibilities?
Do senior leaders ensure their commitment to quality is met when delegating

oversight of quality? Is the amount of work and the duration defined for the
delegation?
Do senior leaders communicate clearly and effectively regarding their

delegation of quality oversight responsibilities?
When senior leaders delegate do they ensure it is only to individuals who are
qualified and have sufficient resources necessary to assume the
responsibility?
Is the delegation of responsibility documented?
How do senior leaders ensure that those individuals to whom the responsibility
has been delegated share their commitment to quality?
How are the needs of stakeholders, collected, assessed and incorporated into
quality expectations?
Are these activities conducted routinely?

Foundational Aspect #3: Organizational Commitment to Quality
F3.1. Senior leaders and managers throughout the

organization should cultivate an environment in
which each individual takes ownership of quality
in his/her role and holds himself/herself and
others accountable for quality. The organization
should empower individuals to address quality
concerns by providing formal channels for
communication and escalation without fear of
reprisal, and the organization should provide
opportunities for open and ongoing dialogue
about quality. Individuals should be encouraged
to identify and bring forward more effective and
efficient ways to undertake activities.
ment to Quality
Rating Average
(0, 1, 2, 3) Rating
F3.1a. Do individuals throughout the organization

take ownership of quality?
0.0
F3.1b Is there a formal channel of communication
and escalation provided through which individuals
can escalate or report quality concerns without fear
of negative consequences?
0
How does the organization empower individuals to address quality concerns?
Is there a way to raise quality concerns anonymously or directly, and do

employees make use of it?
What opportunities exists for open and ongoing dialogue about quality?
How are individuals encouraged to identify and bring forward more effective
and efficient ways to undertake activities?
Foundational Aspect #4: Continuous Improvement
F4.1. The organization should monitor the internal and

external context for changes that might
necessitate modification of its clinical QMS. The
organization should seek opportunities to
enhance effectiveness and/or efficiency of its
clinical QMS. This is generally accomplished by
leveraging outputs from the organization’s
knowledge management activities
F4.2. Modification of an organization’s clinical QMS or

its individual elements should be supported by
appropriate change management activities.
Rating Average
(0, 1, 2, 3) Rating
F4.1a Is the clinical QMS periodically evaluated for

continual improvement?
0.0
F4.1b Is there a process to identify changes,
internally and externally, and decide on
modifications to the clinical QMS?
F4.2a Does the organization consider and apply

appropriate change management activities/tools in
modifying the clinical QMS?
0 0.0
How are the recommended actions from assessing the clinical QMS evaluated
and if required/appropriate, acted upon (e.g., as part of management review)?
How do you ensure that all elements continue to function as intended?
Are adjustments to the clinical QMS made when there is evidence an element
is not working as intended or an interdependency is misaligned or ceased
working as intended?
Are all inputs into the functionality of the clinical QMS periodically reviewed
and how are necessary changes to ensure continued functionality actioned?
Does the process include what internal/external contents would drive a change
to the clinical QMS in the organization?
How does the organization (e.g., people, processes, etc.) utilize change
management tools to identify the required activities that will ensure this
change, as part of continual improvement, is successful?
How are changes evaluated for effectiveness?
How are significant changes proactively evaluated with regard to the level of
disruption to the clinical QMS and/or business and appropriate
improvements/changes incorporated?
How is the portfolio of changes managed and analyzed?
How are changes implemented through the continuous improvement process?

Element #1: Process
1.1. Processes should be well defined and

characterized prior to determining which require
supporting procedural documentation and which
do not. Process mapping and other business
process management tools may support clear
articulation and understanding of processes and
evaluation of the need for formal written
procedures.
1.2. Clear and concise procedural documents (e.g.

policies, standard operating procedures, and
work instructions) should be developed as
necessary to ensure consistency in process
execution.
1.3. Leadership commitment to quality should also

be reflected through review and approval of
procedural documents by appropriate levels of
leadership.
1.4. The organization should identify the appropriate

level and detail of procedural documentation
needed to support clinical development.
1.4. The organization should identify the appropriate
level and detail of procedural documentation
needed to support clinical development.
1.5. Procedural documents should be fit for purpose

and should facilitate individuals in readily
identifying their roles and associated
responsibilities and the context of their roles
within the broader process.
1.6. Consideration should be given to including links

to other relevant procedural documents.
1.7. Procedural documentation should be created or

modified primarily to
- address changes in the underlying process
(e.g. improvements in process efficiency
identified through continuous improvement
activities),
- address evolving customer requirements (e.g.
health authority requirements), or
- mitigate risks to quality objectives.
1.8. The organization should also periodically assess

information from issue management activities to
identify whether issues could be alleviated
through process re-design and/or the
development, revision, and/or retirement of
procedural documents.
1.9. Knowledge management activities may also
identify changes that warrant re-evaluation of
processes and associated documents. These
activities may also identify redundant
documents that could be retired, simplifying the
procedural document infrastructure.
1.10. For any new or revised procedural document,

the organization should consider the burden of
implementation (including change management
activities and training needs) and sustaining the
process relative to the risk or requirement being
addressed by the procedure.
1.11. Organizations should craft procedural
documents to be less sensitive to organizational
changes to avoid frequent administrative
revisions (e.g. referring to generic roles instead
of functional titles or specific individuals by
name).
1.12. The organization should clearly identify those

procedural documents that are considered
mandatory (i.e. represent regulatory or
organizational requirements) and those that
represent best practices and can aid staff in
carrying out their activities.
1.13. Training on procedural documents should be

similarly focused and streamlined.
Consideration should be given to what training
is considered part of the core curriculum for
those engaged in a given activity and which
training could be delivered “Just-in-Time” (i.e.
training timed to the need to carry out a specific
activity).
Rating Average
(0, 1, 2, 3) Rating
1.1a Have processes which require procedural

documents been identified?
1.1b Have processes been evaluated to determine

which process steps need to be formally
documented?
0 0.0
1.1c Have processes been well defined and

characterized?
1.2a Are procedural documents clear, concise and

do they ensure consistency of process execution?
0 0.0
1.3a Have procedures been evaluated to determine

what level of leadership should review and approve
the procedures?
0 0.0
1.4a Are procedural documents written to the

appropriate level of detail needed to support clinical
development? 0
0.0
0.0
1.4b Does the level of detail in the procedures
support consistent execution of clinical development
activities? 0
1.5a Do the procedural documents clearly and

accurately identify the roles and responsibilities for
individuals?
0 0.0
1.6a Are references to other processes/documents

included in procedural documents as appropriate?
0 0.0
1.7a Are related procedural documents adapted to

reflect changes (such as changes to regulation, a
merger/acquisition) in the internal/external 0
environment appropriately?
1.7b Do the procedural documents reflect mitigation

of identified risks to quality objectives?
0 0.0
1.7c Is there a procedure for periodic review and

assessment of procedural documents that ensures
timely revision of the procedures? 0
1.8a Is information from Issue Management factored

into the lifecycle management and continuous
improvement of processes and procedures.
0 0.0
1.9a Has information from Knowledge Management
factored into the lifecycle management and
continuous improvement of processes and
procedures?
0 0.0
1.10a Does the process for developing procedures

include consideration of risk/benefit (i.e., does the
benefit of making the change outweigh the burden 0
of implementation)?
1.10b Does the process for development

procedures include consideration of the impact on
other procedures? 0
1.10c Is Change Management applied to process

and procedural changes?
0
0.0
1.10d Is there a defined communication method to
ensure individuals are notified of procedural
document changes? 0
1.10e Do individuals have ready access to the

documents?
0
1.10f. Is there a defined way to determine the

training needs/requirements for impacted
roles/functions? 0
1.11a Are procedural documents written in a style to
avoid administrative revisions?
0 0.0
1.12a Are mandatory and best practice procedural

documents categorized and identifiable?
0 0.0
1.13a Is training type, content and timing of

processes and/or procedural documents
appropriately aligned to roles and responsibilities? 0
1.13b Has the organization assigned the right

training to the right role, to assure the type of
training is the right training for the procedure? 0 0.0
1.13c Are regular reviews of the training curriculum

conducted?
0
Have processes been well defined and characterized, for example by using
process mapping/other appropriate business process management tools,
considering roles and hand-offs?
Has the process been assessed against regulatory requirements across all
relevant countries and regions? Do steps identified in the process satisfy
regulatory requirements?
Have those steps within the process been evaluated to determine what needs
to be documented to ensure quality objectives are being met?
Have the processes been evaluated to determine which need to be formal

written procedures?
Do the processes have adequate measures embedded to demonstrate

quality?
Is there evidence that procedures are carried out consistently across functions,
geographical location, therapeutic areas, etc.?
Are procedural documents written to facilitate consistent execution of the

activity?
Are there guidelines for the approval level appropriate for policies, procedures,
standards, tools, etc.
Has the appropriate level of leadership to review and approve procedural

documents been identified?
Does appropriate leadership consistently review and approve procedural

documents?
The level of detail in procedural documents should be such to facilitate

consistent execution of the activity, while allowing for flexibility to avoid
unnecessary deviations and/or confusion.
The level of detail in procedural documents should be such to facilitate
consistent execution of the activity, while allowing for flexibility to avoid
unnecessary deviations and/or confusion.
Do procedural documents assist individuals in understanding who is

responsible and accountable in the procedures?
Do the processes clearly identify interaction to support the process flow both
within and between processes?
References may be to the procedure title or number.
If using a live link or URL, are they regularly reviewed and updated, as
needed?
Consider changes in the regulatory environment, changes to improve the

process, or changing customer needs.
Before developing a procedural document to mitigate a risk, the organization

should verify that this action will meaningfully reduce the risk or eliminate its
root cause.
Has information from Issue Management been utilized to identify trends and
evaluate necessary changes to processes and procedures and opportunities
for improvement?
Are knowledge management activities assessed to identify any need for
changes to processes and their respective procedural documents?
When initiating new procedures or during periodic review of procedures, are

existing procedures evaluated with regard to impact to other processes (i.e.,
resources, training needs, etc.)?
Is the risk of making the change vs not making a change considered in

evaluating the risk/benefit of the change?
Ensure understanding of the impact a change to a procedure has on other

procedures, even if owned by other functions.
Does the organization determine how staff will be made aware of new and/or
amended procedural documents and determine appropriate architecture and
methods to permit ready access by staff members?
Is referencing certain individuals by name or title in a procedure avoided?
Are there any best practices determined to avoid frequent revision of

procedural documents (e.g., definitions of specific terminology maintained in a
separate glossary rather than in the procedural document itself)?
If URL links are embedded in a procedure are they regularly reviewed and
updated, as needed?
Is it obvious to staff which documents are mandatory and which are

optional/guidance/best practice?
How is a document evaluated to determine if it should be mandatory or

optional/guidance/best practice?
Has the organization developed a training role and curriculum matrix and
differentiated core vs ad hoc or just in time training or a combination of both
training approaches?
Have the training requirements for individual roles been appropriately aligned?
How is the timing of training evaluated to ensure it is appropriate?
Does the regular review of the training curriculum include consideration of the
appropriateness of job roles and execution of activities?
Is it clearly defined, who is responsible for set-up/maintenance/regular review

of the training curriculum/matrix?
Element #2: Resources, Roles, and Responsibilities
2.1. The organization should prospectively evaluate

the required resources and skillsets for
achieving its clinical strategy.
2.2. The organization’s leadership should ensure that

appropriate resources are available, including
both material resources (systems, standards,
training environments) and staff.
2.3. For staff members, leaders should ensure that

there is clarity in roles, responsibilities, and
accountability for operational effectiveness and
quality at all levels throughout the organization,
including with its partners.
2.4. Leaders at all levels should manage resources in

a proactive manner, by anticipating resource
and expertise needs according to the strategic
direction of the organization, its evolving risk
profile, as well as the evolving regulatory
environment.
2.5. All staff, including temporary personnel and
contractors, should be qualified by appropriate
education, training, and/or experience to perform
the activities for which they are responsible
(“right people in the right place”).
2.6. Prospective consideration should be given to

the knowledge and competencies required for
each role and how these competencies and
knowledge will be achieved.
Rating Average
(0, 1, 2, 3) Rating
2.1a Is a prospective review of resource needs

conducted against planned business objectives?
0
0.0
2.1b Is planning of allocation of resources based on
a clear understanding of the demands of the
activity/business objective, including anticipation of 0
changes to the clinical strategy?
2.2a Are material and individual resources

evaluated and allocated to ensure achievement of
clinical strategy and conduct of clinical development
activities? 0
0.0
2.2b Does the organization’s leadership have a
realistic understanding and knowledge of resource
needs to ensure adequate allocation of resources to
achieve the clinical strategy and conduct clinical 0
development activities?
2.3a Is there clarity in roles, responsibilities and

accountabilities at all levels throughout the
organization? 0
0.0
2.3b Are roles, responsibilities and accountabilities
clearly established and communicated?
0
2.4a Is a proactive review and resource planning by

the organization’s leaders conducted and acted
upon? 0
0.0
2.4b Is a risk management approach applied to the
planning and allocation of resources?
0
2.5a Does the organization have job descriptions
that clearly describe qualifications based on role? 0
2.5b Do hiring/insourcing practices ensure

appropriately qualified individuals are hired or 0 0.0
insourced?
2.5c Are staff assignments appropriate for the
expertise needed to conduct the role? 0
2.6a Does the organization provide methods to

sustain and increase knowledge and competencies
required by role?
0 0.0
Is a continuing review of changes over time conducted to assess the impact on

resource needs?
Is an assessment of the needs and demands conducted to ensure resources

are appropriately assigned/allocated?
IIs there a periodic assessment of resourcing to support portfolio priorities?
Does the periodic assessment include indicators of quality (i.e., is the periodic
assessment accomplishing what it is intended)?
Are the functional lines that support trial activities aligned on the priorities and
balanced to meet the needs of the portfolio?
When Issues that Matter do occur, are resources considered?
Are all roles, responsibilities and accountabilities consistently and clearly

defined, documented and communicated at all levels in the organization?
Are these periodically reviewed and updated?
Is the organization’s strategic direction and evolving risk profile, and the
current and evolving regulatory environment factored into the planning and
allocation of resources?
Do leaders utilize succession planning to avoid gaps in resources?

Are staff qualifications appropriately documented, routinely reviewed and
updated as necessary?
Is a review conducted to ensure that credentials are available where required

(e.g., QP viva, Medical License/Registration/Approbation)?
How are employees made aware or being trained on the elements of a clinical
QMS?
Is continuing education and other appropriate methods/tools/materials

consistently utilized to ensure staff have current knowledge and skills required
relative to the role to which they are assigned?
Are training materials and curricula periodically reviewed and updated?

Element #3: Partnering
3.1. The organization should prospectively consider

the needs, expectations, and limitations of all
parties involved in a partnership as well as the
risks posed by the activities to be carried out in
such partnerships.
3.2. The parties should be transparent about known

risks relevant to the partnered activities and
should agree upon an appropriate strategy for
proactively identifying, assessing, addressing
risks throughout the partnership.
3.3. While the Sponsor or Marketing Authorization

Holder has ultimate accountability for quality,
each party should take ownership of quality for
its contribution to the partnership.
3.4. A common understanding should be established
among all parties regarding their specific roles
in the overall quality of the partnered activities
and how oversight of quality will be maintained.
This should include their respective roles and
responsibilities and how issues will be managed
and escalated.
3.5. Where applicable, the parties should

prospectively determine how to bridge their
respective quality systems in the management
of the partnered activity.
3.6. The level of documentation and oversight of

partnered activities should be commensurate
with the risks of the activities.
with the risks of the activities.
3.7. The parties should periodically monitor and

discuss the performance of all aspects of the
partnership and identify and implement any
needed improvements.
Rating Average
(0, 1, 2, 3) Rating
3.1a Have the needs and expectations of all parties

in a partnership been assessed?
0
0.0
3.1b Is a prospective risk assessment conducted to
discuss and address the needs, expectations,
limitations and risks posed by the activities carried
out in the partnership? 0
3.2a Do partnerships foster open communication

and transparency of risks between all involved
parties? 0
0.0
3.2b Do all parties in the partnership mutually agree
upon a strategy for proactive identification,
assessment and resolution of risks throughout the 0
life of the partnership?
3.3a Is it ensured that all parties take ownership of

quality for their contributions in the partnership?
0 0.0
3.4a Is assignment of governance and oversight
established to ensure that information is exchanged
between partners in an open, timely and efficient
manner?
0.0
3.4b Are roles and responsibilities defined with
respect to which party has oversight for which
activities, how oversight of quality is maintained, and
how issues are managed and escalated?
3.5a Are quality agreements proactively established

for partnerships to cover all relevant elements of a
clinical QMS?
0 0.0
3.6a Is the documentation of partnered activities

relevant to the level of risk of the activities?
0
0.0
3.6b Is the documentation of the responsibility of
oversight of the partnered activities relevant to the
risk of the activities?
0 0.0
3.6c Is there documentation that demonstrates the

execution of oversight of the partnered activities?
0
3.7a Is the performance of the activities in the

partnership periodically reviewed?
0
0.0
3.7b Are identified needs for improvement acted
upon and implemented, as necessary?
0
Are the needs and expectations discussed between both parties prior to
engaging in a partnership?
Is there a mechanism to ensure demonstrated understanding of, and

agreement to how the needs and expectations will be met?
Are the limitations of the partnership evaluated and addressed prospectively?
Are the agreed expectations from each party clearly documented in the
contract?
Does the process on prospective risk assessments in partnerships facilitate

reciprocal transparency on all known risks relevant to the partnered activities?
Is there an agreement on the strategy and mechanisms for proactively

identifying, assessing, and addressing risks throughout the partnership?
How is this communicated to relevant parties on both sides of the partnership,

as well as other stakeholders (suppliers/vendors, etc.?)
The parties should prospectively agree regarding expectations for how

activities will be conducted and overseen, communications (including
escalations) will be managed, and performance will be measured.
Expectations between all parties in the partnership should be as clear as

possible and consider the use of tools such as RACI to document these
expectations.
Is there need for a formal governance structure for the relationship?
Who has decision rights and in what context?
What specific expectations does each party have related to quality and
compliance?
Are there specific considerations based on the activities and/or geography in

which the activities take place?
Are regular meetings (such as established operational and quality governance
bodies) conducted to discuss all relevant activities to the partnership (e.g.,
quality performance metrics, issues, audits/inspections, etc.), and is this
documented?
Are communication plans and pathways established to ensure transparency in

sharing of information and issues?
Consider how oversight of sub-contracting is accomplished and communicated

to all relevant parties.
What are the specific tasks or activities that each party will carry out?
Is there a mutual understanding of the scope of each activity (where it begins

and where it ends)?
What are the roles and responsibilities & accountabilities of the various staff
and functions at the vendor and sponsor?
Have the similarities and dissimilarities in the quality systems been assessed?
Have the partners come to agreement on how to work through the

dissimilarities?
How will each organization contribute to the overall management of risks as

they are identified to assure no gaps or redundancies?
Which SOPs will be followed (including consideration of any training

requirements)?
Is non-GCP-related training required for vendor staff (e.g., policies on

business conduct or privacy)?
The parties should prospectively document their agreement regarding

expectations for how activities will be conducted and overseen,
communications (including escalations) will be managed, and performance will
be measured.
Is the type of documentation (e.g., clause vs contract/agreement) and level of

detail incorporated in the documentation aligned with the risks of the activities?
If a RACI is used, does it include all critical aspects (e.g., health authority
notification, inspection notification, escalation of issues, etc.) of the partnered
activities?
What are the key risks related to the activities being undertaken in
partnership?
To whom and when should information about new or changing risks and/or
issues be communicated (including escalations)?
If a RACI is used, does it include all critical aspects (e.g., health authority
notification, inspection notification, escalation of issues, etc.) of the partnered
activities?
What are the key risks related to the activities being undertaken in
partnership?
To whom and when should information about new or changing risks and/or
issues be communicated (including escalations)?
Where, how, and by whom will required records be maintained during the
partnership and after its completion?
Is there a process in place to monitor and discuss periodically the performance

of all aspects of the partnership and to identify and implement any needed
improvements?
How will specific key performance indicators (KPIs) and key quality indicators
(KQIs) be monitored and reviewed?
Element #4: Risk Management
4.1. Risk management should ideally be integrated

into day-to-day decision making throughout the
organization.
Communication and consultation:

Appropriate communication and consultation
with stakeholders, including health authorities
as applicable, should occur at all stages of the
risk management process.
4.2. An organization’s senior leadership should

communicate the value of risk management and
demonstrate their consideration of risk in
decision making (e.g. when setting
organizational strategic plans).
4.3. The organization should prospectively define a

framework for how it will manage risks
effectively and efficiently, including how risk
management will be integrated with other
activities (e.g. in setting the thresholds for issue
triage).
activities (e.g. in setting the thresholds for issue
triage).
4.4. The framework and associated activities should

permit the organization to differentiate
significant risks from those with minimal impact
on patient safety, data integrity/scientific rigor,
regulatory compliance, and trust in the
organization.
4.5. The framework should enable the integration of

risks across functions and clinical development
programs to provide leadership with a holistic
view of significant risks and their mitigations.
programs to provide leadership with a holistic
view of significant risks and their mitigations.
4.6. Risk mitigation:

Action(s) are identified that will address the risk.
Risk monitoring and review:

The organization should evaluate whether
actions taken to address risks are achieving the
desired outcome.
Rating Average
(0, 1, 2, 3) Rating
4.1a Does the company’s culture foster a mindset of

risk management?
4.1b Is risk management imbedded into routine

decision making throughout the organization?
0 0.0
4.1c Does appropriate communication and

consultation with stakeholders occur at all stages of
the risk management process?
0
4.2a Does senior leadership clearly communicate

and actively support a culture of risk management?
0 0.0
4.3a Is there a defined process for managing risk?
0.0
4.3b Is the risk management framework set up to
interlink with other elements in the clinical QMS
(e.g., issue management, knowledge management)
and to incorporate information from the other
sources in managing risk? 0
0.0
4.3c Is information gleaned from risk management
activities utilized to effectively and efficiently
eliminate or decrease risks?
0
4.3d Is information about internal (QMS elements)

and external environment leveraged to identify
changes that might influence risk assessment?
0
4.4a Is there a consistent process for conducting a

risk assessment that enables the organization to
differentiate risks based on significance?
0.0
4.4b Are risks identified, analyzed, and evaluated to
determine the need for mitigations?
4.5a Does the framework collate or integrate risks

that are identified across functions, processes, etc.
to allow for transparency and ensure a holistic view
of identification and mitigation? 0
0.0
0.0
4.5b Is there a process that ensures leadership has
holistic visibility into risks across the organization?
0
4.6a Are your risk mitigations developed to

appropriately address (or accept) the risk?
4.6b Are the actions evaluated to identify how it can

lower the risk level?
0.0
4.6c. Are the risk mitigations effective?
4.6d. Does the monitoring and review of risks

produce sufficient information (from IM for example)
to keep risk context and risk assessment current?
0
Are risk assessments, evaluations and associated mitigation considered in day

to day decision-making?
Is consideration of risk applied proactively or reactively?

Are risk management methods applied within the organization?
Is assessment of risk for key activities conducted and documented, when

appropriate, prior to execution of the activity?
Are you communicating with stakeholders and obtaining their agreement that
risk management activities are appropriate?
If applicable to the organization, how does project/program/portfolio level risk

management integrate with the organization’s Enterprise Risk Management
strategy/program?
Does senior leadership consciously apply risk assessment in the decision-

making process?
Does senior leadership actively communicate the value of incorporating the

identification and characterization of risk to permit timely and data-driven
decisions regarding if/how a risk needs to be addressed?
Is the framework for managing risk, designed to focus on potential events with
a range of potential consequences (i.e., risks)?
Does the framework utilize information/evidence from events that have

occurred (i.e., issues) to best articulate and assess risks?
Are risks that are identified compared to risks that are realized i.e., (issues) to
determine effectiveness and efficiency of risk mitigations?
Is the risk management framework reviewed periodically to ensure

effectiveness and efficiency of the framework and execution to its strategy?
Is the risk management strategy aligned with the organizational strategy,

regulatory environment and customer expectations?
Understanding the Context:

Risk management activities should leverage information about the internal and
external environment to identify changes that might create risks.
Do you leverage information from the internal and external environments to

occurred (i.e., issues) to best articulate and assess risks?
Are risks that are identified compared to risks that are realized i.e., (issues) to
determine effectiveness and efficiency of risk mitigations?
Is the risk management framework reviewed periodically to ensure

effectiveness and efficiency of the framework and execution to its strategy?
Is the risk management strategy aligned with the organizational strategy,

regulatory environment and customer expectations?
Understanding the Context:

Risk management activities should leverage information about the internal and
external environment to identify changes that might create risks.
Do you leverage information from the internal and external environments to

identify changes that might influence your assessment?
Internal consideration should be given to clinical QMS elements such as

knowledge management, issue management, understanding the context
External consideration should be given to regulatory trends
Does the framework enable differentiation between risks based on significance

that factors in impact, probability and detectability?
Does the risk assessment yield an understanding of how significant a risk is to

objectives and lead to a decision on whether or not a risk requires action?
Risks are analyzed by considering the impact (significance) of its

consequences, how likely it is that these consequences will occur, and the
effectiveness of existing risk mitigations.
The combination of the impact and likelihood, accounting for the effect of
existing mitigations, is the current level of risk.
Risks are evaluated by comparing the current level of risk to the level of risk
the organization will accept to determine whether actions need to be taken to
reduce the risk
Are risks identified for individual studies, programs, and across functions for
clinical development?
Consideration should be given to how risk is reported holistically for

leadership, integrating risk across functions) (e.g., PV safety signals, labeling
updates to core data sheets, publications, etc.)
Consideration should be given to how risk is reported holistically for
leadership, integrating risk across functions) (e.g., PV safety signals, labeling
updates to core data sheets, publications, etc.)
Organizations should consider a range of options including avoiding the risk,

changing its likelihood and/or consequences, transferring the risk (e.g. through
insurance), or accepting the risk by informed decision.
Do you develop mitigations for the identified risks?
The combination of the impact and likelihood, accounting for the effect of
existing mitigations, is the current level of risk.
Do the proposed mitigation actions reduce risk to an acceptable level, or do
they increase burden without benefit?
Do you monitor your risks, and occasionally review them so they are as
accurate as possible? (e.g. if you identify as risk as low because it should rare,
is it rarely occurring during the study, or is it occurring more often?)
Issue management will provide valuable insight into risk mitigation strategies
that may not be optimal. When an issue occurs, risk assessment should be
revisited to determine whether the risk of the issue occurring was not identified
during assessment; whether risk mitigations were appropriately designed but
not implemented; and/or whether new risk mitigation activities are needed to
appropriately control the risk. In addition, the organization should periodically
assess whether changes in the internal or external context (e.g., new
regulations) or accumulating information from knowledge and issue
management activities (e.g., trend analyses) might yield new risks or modify
existing risk management strategies.
Element #5: Issue Management (IM)
5.1. An effective issue management framework will

improve identification, investigation/
assessment, escalation, and communication of
significant issues (i.e., “Issues that Matter”).
5.2. With an effective issue management framework,

significant issues should not recur, drugs may
get to patients faster, and resource requirements
of drug development may be reduced, all
contributing to the improvement of the quality of
clinical studies.
5.3. Issue Detection
Within any organization, issues can be reported
or detected by examining information from
multiple sources. Use of methodologies that
integrate information from different sources may
result in identification of issues that would not
be found from any single source alone.
5.4. Issue Documentation and Investigation

“Issues that Matter” should be investigated
(gathering of pertinent information to facilitate
analysis), analyzed (determining the underlying
root cause[s] of the issue), and corrected/
prevented via a robust CAPA plan.
5.5. There should be ongoing assessment of any

immediate corrections needed as well as the
need for escalation to management and
reporting to regulatory agencies.
5.6. Issues not meeting the threshold for significance

should be documented as appropriate to enable
trending. This documentation should be
commensurate with the complexity of the issue
and potential impact.
5.7. CAPA Process
“Issues that Matter” should be managed by a
CAPA process.
5.8. Delays or significant challenges with the

execution of the CAPA process should be
escalated to an appropriate level of
management.
5.9. Trending and Analytics

An effective issue management framework
should foster continuous improvement and
enhance risk management through detection of
trends that may represent systemic issues or
risks. Trend analysis is also a vital input to risk
assessment (e.g. providing information on the
likelihood of an event occurring).
should foster continuous improvement and
enhance risk management through detection of
trends that may represent systemic issues or
risks. Trend analysis is also a vital input to risk
assessment (e.g. providing information on the
likelihood of an event occurring).
5.10. Trending activities may lead to the identification

of new Issues that Matter for which appropriate
actions should be taken.
Rating Average
(0, 1, 2, 3) Rating
5.1a Is there an IM framework?
5.1b Does the IM framework define significant

issues (i.e., “Issues that Matter”)?
0 0.0
5.1c Does the IM framework provide instruction on

how to identify, investigate, escalate and
communicate significant issues?
0
5.2a Is the IM framework effective in reducing the

recurrence of significant issues?
0 0.0
5.3a Does the IM framework utilize information
derived from a variety of sources to facilitate the
identification of issues that might not otherwise be
detected?
0 0.0
5.4a Does the IM framework incorporate a CAPA

process?
0.0
5.4b Is a full impact assessment conducted and a
problem statement developed prior to identifying
root cause?
0
5.5a Are immediate corrections sufficiently

assessed and appropriately reported?
0
0.0
5.5b Is there a process of ongoing assessment and
appropriate escalation to management and
authorities? 0
5.6a Are issues that do not meet the criteria of

Issues that Matter documented to allow for effective
trending?
0 0.0
5.7a Is there a robust CAPA process to sufficiently
and appropriately manage Issues that Matter?
0.0
5.7b Is the level of investigation or root cause
analysis commensurate with the severity of the
issue?
5.8a Does the process allow for escalation and

resolution for delays and/or significant challenges
that may arise during the execution of the CAPA
process? 0
0.0
5.8b Is there a process to effectively track
adherence to internal intermediate time targets for
CAPA process?
0
5.9a Are the learnings or findings from Issue

Trending and Analytics evaluated or considered as
part of the overall continuous improvement 0
activities?
0.0
0.0
5.9b Is the information from Trending and Analytics
provided as an input to risk management?
0
5.10a Is there a systematic approach to trending

and analysis of issues?
5.10b Does the trending activities result in 0.0

identification of new issues that matter and ensure
they are addressed as part of the issue
management process?
0
Is there connectivity between how issues are managed throughout the

organization to allow visibility for these issues that require further escalation
and communication?
Does the IM framework differentiate issues by the level of significance,

criticality and/or impact?
Does the IM framework provide a definition for significant issues that include,
but may not be limited to:
• Patient safety, rights and well-being
• Data integrity and/or scientific rigor
• Compliance with regulatory requirements
• Trust in the clinical research enterprise?
Are issues triaged according to their significance (i.e., significant issues/issues

that matter from all other issues)?
Does the IM framework include escalation and communication of significant

issues within the organization (including notification to leadership, customers,
suppliers/vendors, where applicable), and to Health Authorities where
required?
How does the organization track and trend reoccurrence of identified issues?
How does the organization track issues to determine the effectiveness of the
applied remediation (correct the issue)?
How does the organization assess root cause to ensure fit-for-purpose

remediation?
How does the organization conduct effectiveness checks (eliminate root

cause)?
How are issues communicated throughout the organization (e.g., incorporating

transparency in sharing of experience)?
What are the sources that issues can be detected and reported by?
How does the IM framework allow for collation of issues from different/multiple
sources?
Does the process take into consideration issues that occur in one area that
could impact quality in other areas?
How is the information communicated and actioned to take into consideration
all areas that are impacted?
How are issues investigated and analyzed to determine root cause?
Does the process evaluate the immediate corrections for effectiveness?
Are issues tracked, monitored, followed up holistically and in aggregate over

time?
Do the escalation or reporting communications include documentation details

of any immediate corrections?
Does the process include criteria for ensuring consistent escalation to

management?
Are issue(s) and the immediate correction(s) evaluated for the need to
communicate to management and regulatory authorities as appropriate?
Is there an intake system for “all” issues regardless of severity or rating?
Does the intake system ensure minimum documentation of the issue is

captured to ensure effective trending?
How are issues trended? For example: Date, Location, Short Descriptions,
Category, Types and Sub Types as appropriate.
Does the organization clearly distinguish between immediate action
(Correction), Corrective Action and Preventive Actions?
Do you have a consistent methodology for Root Cause Analysis?
Does the CAPA process effectively address the basic elements below?
The basic elements of an effective and sustainable CAPA process include:
(a) Taking immediate action to prevent further negative impact from the issue
(correction).
(b) Identifying the accountable person(s) for:
(1) Investigating the issue (gathering the necessary information);
(2) Determining the underlying root cause of the issue (e.g., through
performing root cause analysis); and
(3) Performing a holistic assessment of the scope and impact of the issue to
understand whether it is isolated or systemic.
(c) Identifying the accountable person(s) to develop a robust CAPA plan with
at least the following elements:
(1) Actions that address the identified root causes;
(2) Implementation details including assigned responsibilities and timelines;
and
(3) Effectiveness checks to ensure the actions achieve the desired outcome
and future occurrences are prevented.
(d) Implementing the CAPA plan, including effectiveness checks.
(e) Verifying the long-term sustainability of the corrective and preventive
actions.
Are the time targets realistic and agreed upon? Are the time targets used to
proactively evaluated or ensure “on-track” adherence?
How is the accountable/responsible party properly identified based on scope

of the corrective action?
Do the parties have proper authority to implement?
Is there a process to evaluate and manage CAPA extensions or deviations

when appropriate?
How are the learnings or findings from issue trending shared with appropriate
stakeholders as part of knowledge management activities?
How are the learnings or findings from issue trending shared to ensure timely
update of procedural documents?
How are the learnings or findings from issue trending shared to ensure timely
update of procedural documents?
Is there a process to ensure systemic issues are identified consistently?
Are issues that are determined to be a trend or systemic, investigated to

determine the root cause?
Consideration should be given to how trending and analytics results in

trackable actions. Does the Issue Trend Analysis process effectively address
points a-d?
a. Organizational commitment and resources
b. Timely, comprehensive, complete, and meaningful data/information
c. Identification of critical data/information from organizational processes and
activities
d. Method for accessing/analyzing the data/information in knowledge
management repositories (e.g. data/information structured for ease of
retrieval)
Element #6: Knowledge Management*
*NOTE: The following section on Knowledge Management is a higher-level assessment compared to the Clinical Knowle
Clinical QMS assessment tool is sufficient; otherwise the more granular CKM assessment tool should be used.
6.1. Implementing a structured approach to KM

within clinical development can enable
organizations to effectively utilize knowledge,
thereby accelerating delivery of new medicines
to patients by
a. increasing productivity by enabling
employees to search, find, and apply knowledge
faster;
b. achieving and improving quality and
compliance through leveraging best practices
and lessons learned; and
c. enhancing the ability to maintain and sustain
institutional knowledge so that it can be shared
and applied at an organizational level.
6.2. A KM framework includes strategies and

processes designed to identify, capture,
structure, value, leverage, and share the
organization’s intellectual assets to enhance the
clinical development organization’s performance
and the performance of clinical QMS elements
including issue management and risk
management.
6.3. There are two types of knowledge the

organization should consider: explicit and tacit.
6.4. A knowledge-sharing culture and continuous
improvement of the KM framework are important
foundational aspects of the KM framework
employed by the organization. Organizations
should take steps to address behaviors that may
impede knowledge sharing (e.g., the perception
that knowledge is power). A KM framework may
include the following:
a. People responsible for sponsorship,
contribution, and application of knowledge, and
the maintenance and credibility of the captured
and stored knowledge.
b. Processes that drive and support the
implementation of knowledge management
within the organization.
c. Content that includes and enables access to
and retrieval of critical knowledge and/or subject
matter experts.
d. Technology as an enabler to facilitate capture,
use, and maintenance of critical knowledge over
time.
6.5. The following considerations can further support
the implementation of an effective KM
framework:
a. Understand the Knowledge Needs: Identify the
critical knowledge necessary to drive optimal
outcomes tailored to organizational needs.
b. Assess Opportunity: Understand where
improvement of knowledge flow may provide
opportunity for enhanced execution to improve
critical business outcomes.
c. Design and Implement Solutions: Define and
deploy mechanisms to enable and improve
knowledge access and sharing.
d. Improve and Sustain: Assess performance
against anticipated outcomes and adjust as
necessary. Assess opportunities for continuous
improvement to sustain the framework over
time.
a higher-level assessment compared to the Clinical Knowledge Management (CKM) assessment tool developed in conjunction with
e granular CKM assessment tool should be used.
Rating Average
(0, 1, 2, 3) Rating
6.1a is there a structured approach to KM

implemented which enables organizations to utilize
knowledge effectively?
0 0.0
6.2a Are strategies and processes designed to

identify, capture, structure, value, leverage and
share intellectual assets incorporated into the
organizations KM framework? 0
0.0
6.2b Are those assets used to enhance the
performance of all elements of the clinical QMS?
6.3a Is there an understanding within the

organization on the difference between explicit and
tacit knowledge?
0.0
0.0
6.3b Are processes in place to ensure that tacit

knowledge is retained within the organization and
made available to others?
0
6.4a Does the organization foster a culture of

knowledge-sharing and continuous improvement?
0 0.0
6.5a Is there a routine assessment of the KM
framework to ensure its ongoing effectiveness to
address the changing needs of the organization
over time?
0 0.0
developed in conjunction with the CKM manuscript. If just a high-level assessment is needed, this
Is there a process in place whereby employees can search, find, and apply
knowledge quickly?
How are best practices and lessons learned shared?
How is institutional knowledge maintained, sustained, shared and applied at

an organizational level?
Are subject matter experts identified and is a list maintained?
How are the fundamentals of the KM framework incorporated to into strategies

and process to ensure:
a. the capture, storage, and accessibility of institutional explicit (formal and

systematic) and tacit (personal expertise) knowledge, and
b. its assimilation, interpretation, dissemination, application,
and maintenance within an organization.
Explicit knowledge is visible and easily recognized, shared, documented, and

accessed, examples include tangible items such as procedural documents and
clinical development plans.
Tacit knowledge is harder to identify, document, and transfer as it is mainly

acquired from the experience of individuals or groups (e. g. subject matter
experts and trial teams). The loss of tacit knowledge may be most evident
when a key employee leaves an organization. In cases where ‘‘tacit’’
knowledge cannot readily be made ‘‘explicit,’’ mechanisms for collaboration
and communication will help the exchange and maintenance of this
knowledge.
Is there a process when people leave the organization to ensure that the
knowledge leaving with them (i.e. tacit knowledge) is captured, transferred?
Is there a process for capturing tacit knowledge continuously?

when a key employee leaves an organization. In cases where ‘‘tacit’’
knowledge cannot readily be made ‘‘explicit,’’ mechanisms for collaboration
and communication will help the exchange and maintenance of this
knowledge.
Is there a process when people leave the organization to ensure that the
knowledge leaving with them (i.e. tacit knowledge) is captured, transferred?
Is there a process for capturing tacit knowledge continuously?
(a) are responsibilities assigned for sponsorship, contribution, application of

knowledge, the maintenance and credibility of the captured and stored
knowledge ?
(b) are processes defined which drive and support the implementation of
knowledge management within the organization?
(c) is there content that includes and enables access to and retrieval of critical
knowledge and/or subject matter experts?
(d) is technology available as to facilitate capture, use, and maintenance of
critical knowledge?
Are the following aspects considered in determining the effectiveness of the
KM framework?
a. Does the organization understand what it’s key/critical knowledge is? Is

there a mechanism in place to ensure this knowledge is retained? How is
critical knowledge identified to determine its importance relative to the
organization’s needs in regard to the frequency and criticality?
b. Is there a mechanism to enhance critical business outcomes through

knowledge sharing?
c. What is the mechanism to ensure and improve knowledge is readily

accessible and shared across the organization?
d. Is the performance of the knowledge management system reviewed and

assessed at regular intervals and improved to ensure a sustainable framework
over time?
Element #7: Documentation Supporting Achievement of Quality
7.1. The level of documentation for any clinical

development-related process should be
commensurate with the risks of the activity and
the significance of the activity to achieving
quality objectives and meeting stakeholder
requirements.
7.2. How, where, and for what period of time

documentation will be retained should be
established prospectively.
ment of Quality
Rating Average
(0, 1, 2, 3) Rating
7.1a Has the organization considered what

documentation is needed to demonstrate the
achievement of quality in the activities including
requirements of stakeholders?
0
0.0
7.1b Does the organization take into consideration
the risks associated with an activity, the criticality or
importance of the activity, and stakeholder
requirements when determining what documentation
is necessary to demonstrate the achievement of 0
quality?
7.2a Is there a process defining the retention of

documentation (how, where, how long)?
0
0.0
7.2b Does the organization have a process that
defines retention of documentation?
0
Have the processes been evaluated to determine their significance and their
risks in achieving quality objectives?
Is the level of documentation required commensurate with the significance of

the activities?
Are the stakeholder requirements considered when determining what

documentation is necessary?
Document retention procedures should be in compliance with company and

regulatory requirements.
What are the requirements for retention of documentation (how documents will
be retained, where they will be stored, and for how long)?
Element #8: Assessing a Clinical QMS
8.1. To ensure the initial implementation and

ongoing effectiveness and efficiency of its
clinical QMS, the organization should
prospectively define how the elements and
foundational aspects will be evaluated.
8.2. The performance of the clinical QMS elements

should be assessed both individually and in
aggregate.
8.3. These assessments are an important input to

management review.
8.4. A baseline assessment should be performed,

followed by periodic evaluations at appropriate
intervals as part of continuous improvement or
in response to changes in the organization’s
environment.
Rating Average
(0, 1, 2, 3) Rating
8.1a Has the organization considered the

importance of periodic evaluation of its clinical QMS
in ensuring its initial implementation and ongoing 0
effectiveness is fit for purpose?
0.0
8.1b Has the organization prospectively defined how
the elements and foundational aspects of its clinical
QMS will be evaluated? 0
8.2a Is the process on assessing the clinical QMS

elements structured to include individual and
interdependent evaluation of the elements and
foundational aspects?
0 0.0
8.3a Is the result of the assessment included in

management review?
0 0.0
8.4a Does the process include a periodic evaluation

of the clinical QMS?
0 0.0
This clinical QMS assessment tool should be used to initially assess an

organization’s clinical QMS for suitability to the organization’s context, and
periodically thereafter to ensure its continued suitability.
The assessment should evaluate each element individually to assess how it is

functioning.
Following completion of individual assessment of the elements a review of the

elements in aggregate should be conducted to determine if each element
continues to function optimally and in concert with all other elements.
Is the assessment conducted to avoid subjectivity?
Include different stakeholders and levels of management of the areas

addressed by the clinical QMS.
Who drives the conduct of the assessment? Ownership should be shared by

the clinical organization and quality?
Have periodic reviews been scheduled?
Has any action been taken as a result of the periodic review?

Element #9: Management Review
9.1. Senior leadership with the appropriate

accountability and decision-making authority for
clinical development should periodically review
the performance of the clinical QMS to ensure
that it
a. continues to fulfill the quality objectives,
b. remains aligned with the strategic direction of
the organization,
c. is supported by appropriate resources, and
d. provides benefits that exceed the burden of
maintenance.
9.2. The frequency, structure, and content of the

management reviews should be based on the
maturity of the clinical QMS and the complexity
of the organization. During this review, senior
leaders should determine the need for action
and communicate decisions to all appropriate
levels within the organization.
Rating Average
(0, 1, 2, 3) Rating
9.1a Does senior leadership routinely review

performance of the clinical QMS?
0.0
9.1b Does the senior leadership take accountability
and make decisions to ensure desired clinical QMS
performance?
0
9.2a Is the periodic review frequency, structure and

content set-up to meet the needs driven by the
maturity of the clinical QMS and the complexity of
the organization? 0
9.2b Are senior leaders evaluating the results and

defining appropriate actions?
0 0.0
9.2c Are the results of the review and actions

communicated effectively to the organization?
0
Consideration should be given to defining the appropriate senior leadership

with the responsibility to perform reviews and authority to take appropriate
action or follow up to ensure continued improvement of the clinical QMS.
Does this review ensure the clinical QMS:

a. continues to fulfill the quality objectives of the organization,
b. remains aligned with the strategic direction of the organization,
c. is supported by appropriate resources with authority to take action, and
d. provides benefits that exceed the burden of maintenance.
Consideration should be given to determine if a governance structure and

charter should be established to ensure appropriate oversight. This may
include for example defining senior leadership attendees with appropriate
accountability and decision making authority and how resulting decisions will
be documented and communicated throughout the organization.
What methodology is used to conduct periodic reviews considering how often

reviews are necessary?
What is reviewed?
How does senior leadership evaluate the results of the review and assign
action, including who the action is assigned to and what the delivery is?
How are actions designed and communicated to the responsible individual and
tracked to completion?
Status Overview: Quality Management System
Overall Initial QMS Status 1. Process
Enter name
on Start tab
[1.1.]
[1.2.]
[1.3.]
[1.4.]
Legend
Rank = 0 or Blank
[1.5.]
Rank = 1 or 2
Rank = 3
[1.6.]
Printed on: 10:55:45 07/20/2020

Transcelerate Clinical Qms Assessment Tool: Abbreviations and Acronyms

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TransCelerate Clinical QMS Asse

Foundational Aspect #1: Understand the Context

Foundational Aspect #2: Leadership Commitment to Quality

Foundational Aspect #3: Organizational Commitment to Quality

Element #2: Resources, Roles, and Responsibilities

Element #3: Partnering

Element #4: Risk Management

Element #5: Issue Management (IM)

Element #6: Knowledge Management*

Element #7: Documentation Supporting Achievement of Quality

Element #8: Assessing a Clinical QMS

Element #9: Management Review

Abbreviations and Acronyms

CLINICAL QMS Clinical Quality Management System

QMS Quality Management System

RACI Responsible, Accountable, Consult, Inform

A quality management system tailored for the conduct of clinical

A matrix of activities and/or decision making authorities

tool may include technical inaccuracies or typographical errors. Changes may be

Overall Clinical QMS Status Individ

[Foundational Aspect #1:

[Foundational Aspect #2:

[Foundational Aspect #3:

Printed on: 10:55:45 07/20/2020

# of items with # of items with

Statement from Clinical QMS Concept Paper

F1.1. To develop an effective and efficient clinical

F1.2. An understanding of the organization’s

F1.4. Consideration should be given to how a clinical

F1.7. The organization should consult with the range

F1.1a Does the company evaluate and understand

F1.1b Does the company understand its own 0.0

F1.2a Has the organization defined key customers

F1.2b Has the organization communicated with their

F1.2c Is this feedback assessed?

F1.3b Are procedural documents updated and 0.0

F1.4a Are the clinical QMS elements identified and

F1.5a Has the clinical QMS been integrated with the

F1.7a Is a process in place to ensure all relevant

Does the organization define, document and communicate the external

How does the organization identify the roles/functions impacted by the

Does the organization define, document and communicate the internal

Has the organization’s size, complexity, approach to risk, level of commitment

Consider how the organization approaches key customers and stakeholders.

Is the relevant reference knowledge/information retained centrally and

Is the impact to current company policies and procedures assessed, and is

Are findings from prior inspections considered to ensure regulatory

Timeliness of updates should be in conformance with company procedures.

Are changes relevant to partners communicated?

Is the clinical QMS designed considering the organization’s strategic

Are the strategic objectives communicated with the organization?

Do employees demonstrate an understanding of the organization’s strategic

Is the achievement of the objectives monitored? How does the organization

Are strategic objectives developed to ensure quality is integrated into day to

Are the strategic objectives communicated with the organization?

Do employees demonstrate an understanding of the organization’s strategic

Is the achievement of the objectives monitored? How does the organization

Are strategic objectives developed to ensure quality is integrated into day to

Is the size and complexity of the organization taken into consideration?

Is flexibility incorporated into the clinical QMS to allow for changes in

Does the governance structure support swift and transparent decision

Is the governance structure designed to avoid development of silos?

Does the organization’s issue escalation process include members of the