Вы находитесь на странице: 1из 45

Writing SOPs

Dr. Ammar Raza


Clinician, Clinical Affairs Manager &
Teacher
Basic Principle in CR…..

Write down what you do, do what


is written down!
What we will discuss today…
 Background
 What is an SOP?
 Why an SOP?
 Importance of SOPs
 What should an SOP contain?
 Writing SOPs: Intro
 Writing SOPs: General Tips
 How to write a SOP?
 Stopping Problem!!
 Who writes an SOP?
 What format should be used?
 Before & After Writing…….
 What should SOP cover?
 Step-by-step Approach
Background
 Performing CTs is a complicated business
 Bound by regulations & GCP, with the
overriding concern of protecting safety and
welfare of study subjects
 Sites must follow each protocol exactly & meet
other sponsor demands
 Best way to ensure that all these conditions
are met is
 formulate and follow standard operating
procedures (SOPs)
What is an SOP?
 An ESSENTIAL Document
 The who, what, when, how, and why of
clinical research operations
 Ensures consistency, compliance, and
accountability of personnel
 Organizations without clinic-specific SOPs
run a high risk of GCP non-compliance and
poor productivity
What is an SOP?
 Critical tools in successful business
operations for all those involved in doing CTs,
 investigative sites
 sponsors
 IRBs
 SOPs are critical to compliance and high
performance standards
What is an SOP?
ICH-GCP guidelines defines SOPs
“Detailed, written instructions to achieve
uniformity of performance of a specific
function”

 Just that …..The “procedures” & processes


that you use and “operate” under that have
been “standardized” to ensure that you do
them the same way each time
Why SOPs?
 Performing CR is a COMPLICATED business
 It is bound by regulations and GCP
 overriding concern of protecting safety and welfare of
study subjects
 Sites must follow
 each protocol exactly + meet other sponsor demands
 Best ways- formulate and follow SOPs
 They are essential for standardizing processes, for
ensuring
 regulatory & organizational policy requirements r met
 for training new personnel
 for managing workload
Why SOPs?
 Because study protocol is usually a brief
document…… it can give details of how each
procedure is to be done, who will do it etc.
 Provide a historical record of steps in the
how, why and when
 Serve as a training tool for teaching users
Importance of SOPs
 Every good quality system is based on its Standard
Operating Procedures (SOPs)
 SOPs are necessary for a clinical research
organization
 pharmaceutical company
 a sponsor
 a contract research organization
 an investigator site
 an ethics Committee or
 any other party involved in CR
To achieve maximum safety and efficiency of the
performed TASKS
Importance of SOPs
 Audits have shown
 sponsor/CRO files are missing important info
in several areas with respect to sponsor/CRO
training
 no monitor CVs (75% of 226 sites)
 no evidence of training in SOPs (57%)
 No evidence of training in the therapeutic area
(53%)
 no evidence of training in GCP (36%) and
 no evidence of adequate experience
Importance of SOPs
 During of selection of CROs
 First thing done
 Look for SOPs
 quality of SOPs
 compliance with SOPs
 other QA systems (e.g. internal auditing,
proficiency testing),
 determine exactly which SOPs (i.e. sponsor or
CRO) will be used
What should an SOP contain?
 Two parts
 1st part: Outline or summary – includes
 description of the aim or purpose
 scope
 when it should be reviewed and
 known risks associated with the task in
question

Contd…
What should an SOP contain?
 2nd part
 Accurate step-by-step description of how the
task will be carried out
 Who is responsible for each step
Writing SOPs: Intro
 Writing SOPs is not an
easy process
 Very time-consuming
 Involves analysis of
your processes
 pays big dividends
when complete
Writing SOPs: General Tips
 A formal document -describes procedures that will be
followed to accomplish various tasks
 Style of the text should be clear, concise, brief and
specific to the subject
 Should be written to provide instructions for
completion of certain procedures
 Mustn’t be ambiguous or confusing
 Statements concerning procedures to be followed
should be made categorical
 use of words - 'must' and 'will'
 e.g. 'the following procedure must/will be

performed'
Writing SOPs: General Tips
 Important to use words - “will” or “shall” to
describe procedural steps
 Best to avoid words such as “should,” “could,”
and “may.”
 Why?
 These words convey a since of option
 SOPs are not optional
Writing SOPs: General Tips
 The word 'may' is to be used only when the
conditions are stated
 e.g. 'the investigator may enter a patient into
the study without patient consent only in an
emergency and when the patient is
unconscious'
How to write?
Stopping problem!!
•Start at the beginning
•Follow the task through to the end
•Then stop
Sounds easy

 Most writers - no problem getting started


 Sometimes follow thro’ needs more info
 Most difficult thing for most –”to stop”

Avoid long, complex sentences & paragraphs- make


SOP difficult to follow
Avoid Stopping problem!!
 Begin by identifying the purpose of your
SOP’s
1. will help to focus your energy
2. set limitations on the necessary content
 Create an outline of what is actually done on
a day-to-day basis
 Develop the skeleton i.e. the structure of the
SOPs
 important to design your SOPs to achieve
specific results
Designing
Some design options:
 Simple steps
 Hierarchical steps
 Graphic procedures
Who writes?
 Sound, hands on experience
and knowledge of the tasks
 Take input from a no. of
number
 greatly enhance usefulness
of the procedures
 Writing SOPs doesn't require a
degree in ‘alchemy’
 Most important things author of
a SOP can bring to word
processor
 common sense
 logic
Who writes?
 Must convey a clear instruction
 Not only must the user understand the instruction
must also be prepared to carry it out
 The logical step is to let the user, as far as possible,
write the SOP, in collaboration with the Trial Manager
/ Investigator or CRA

 Brings in familiarity, ownership and prevent


awakwardness
 An improved sense of responsibility for obligation to
use and comply with the SOP
What format should be used?
 "Just spill your guts to your computer and
don't worry about the format"
 Format can always be added later
 If there is a fool proof template that can be
given - might help ease some of anxiety of
novice author
Format…example
Table of contents

1 Purpose.................................................................................................2
2 Scope ................................................................................................. 2
3 Abbreviations .......................................................................................2
4 Definitions.............................................................................................3
5 Responsibilities.................................................................................... 5
6 Procedure............................................................................................ 6
6.1 Clinical Trials, phase I-III ................................................................. 6
6.2 Adverse Events Reported Spontaneously on Marketed Products7
6.3 Post-Marketing Studies ................................................................... 9
6.4 Named Patient Supplies.................................................................. 9
7 References..........................................................................................

Annexures/ Appendices/ Attachments: Forms / checklists


Change log
What format should be used?
 Easier to edit SOPs with default formatting rather than a doc
that has many extra tabs and returns added in an attempt to
emulate accepted format
 Many new authors - involved in correct formatting - content
suffers
 Don't rely on spell check to find all misspelled words
 If you use "fur" instead of "for," spell check will blithely
accept it
 Use grammar check with care- not find all goofy little
grammar faux pas that can occur when normal people put
word to page
 If a word is changed using the Replace command, be sure to
individually approve each replace. Universal replacement is
quick and easy - sometimes too easy - and produces fodder
for News
Before & After Writing…….
 Identify need for new SOP
 Gather Input for SOP
 Create SOP
 Review and Approve SOP
 Provide training on SOP and distribute
SOP to relevant audience
 Revision and Deviations of SOPs
 Quality Assurance
 Glossary
What should SOP cover?
 The no. of SOPs
 The arrangement of material in SOPs
 The level of detail in the SOPs
 Depend upon
 entirely on the organization and its related role in CT e.g., the SOPs at the
sponsor’s site will be different than those at the Trial Site
 requirement and role of the staff members executing their work
 Brief outline which in general all the SOPs must cover-
· A descriptive title and indication of the SOP’s position in the total collection.
· Date when the SOP became operative
· The edition number and a statement that this edition replaces an earlier edition
from an earlier date
· The exact distribution of SOPs
· The signature of the person responsible for writing the SOP
· The signature of the person responsible for authorising the SOP
· In some contexts the purpose of the SOP
What should SOP cover?
 Title
 sufficient information about the contents
 placed prominently on page
 to allow the user to identify
 find it easily

 Distribution list directs - to place where it


will be used
 distributed at all related places of its function
 strict check should be kept on nos. of SOPs
issued and distributed at each working area
What should SOP cover?
 Singatures
 Signature of the person
responsible for writing -
shows that - SOP is
complete & correct
 Should an auditor or for that
matter any one else have a
query about the content of
SOP, this would be the
person in contact
 Signature of the person
responsible for authorizing -
shows that SOP is operative
Step-by-Step Approach
 8 steps
1. Mapping the SOP
2. Use of language and Scripting the SOP
3. Editorial responsibilities of SOPs
4. Authorizing the SOPs
5. Distributing and Archiving the SOPs
6. Training of the SOPs
7. Alteration in SOPs
8. Review of the SOPs
Step-by-step approach
 Step 1 - Mapping SOPs
Process mapping –
 laying out all the steps in a currently used process
 analyzing -with goal of making it more efficient and easier to follow
 Involves taking each step in process & “mapping” it into a process chart
 All people - involved in doing task should be involved in mapping it into a process
chart - free and open discussion.
 Often discovered during this process - involved people do not do things same way &
have very different ideas about how current process works and how it should be
done in the future

 SOPs cover all aspects of a CT


protocol preparation
ethical approval
assessing and monitoring trial sites
safety data reporting
checking data integrity
clinical report writing
database preparation
validating computer systems
 all the records are generally created electronically
 FDA’s Draft Guideline - ‘Computerized System used in Clinical Trials’
Step-by-step approach
 SOPs do not have to “fit into a box”. Formats can
vary. Presentation techniques such as flow charts,
diagrams, narratives, tables and bulleted lists should
be considered in addition to the traditional text and
paragraph formats. Presentation might vary, and
should address conditions pertinent to the individual
environment. Procedures should be presented in a
format that will work for the institution and address
specific needs in various ways. The goal is to have
an easily understood procedure that the Clinical
Research Staff will clearly understand and utilize.
Step-by-step approach
 Step 2 - Use of Language & Scripting the SOP
written in the language which is understandable by the staff or people
dealing with it
 If for regulatory purposes or for foreign auditors language has to be in a
foreign language, an authorized translation of the SOP in the local
language which is understandable by its users must be readily available
at the working area

 Authorities, clients & colleagues must be prepared to accept


translations- after all- not primary target

 must communicate their message effectively -must be crystal clear


on who is to do what.
 almost seems too obvious to write, but many SOPs are difficult to
read.
Step-by-step approach
 The rule of thumb for writing instructions in SOPs
is these-
 Use short active sentences
 Use simple words & terms where possible
 Write sentences as instructions:’ do this, do that’
 Write instructions in right order-so operator knows
when to do appropriate task
 Separate instructions from gen info ,either
typographically or by putting gen info in a foot note
 Limit amount of info per page-max 10 different
actions
 Use diagrams wherever appropriate
 Give sources and references at the end
Step-by-step approach
Step 3 - Editorial Responsibilities of SOPs
 It is possible for each dept or section to write, authorize
&produce SOP’s in isolation. For company or sponsor----
advantageous to give someone editorial responsibilities

 Management decides whether or not to edit SOP’s. Suitable


editors might be an interdepartmental GCP committee or some
of the QAU (Quality Assurance Unit) personnel
 Their duties would include checking a new SOP for-
 Style and format
 The edition number
 Consistency of content in context with relevant SOPs from
other departments
 Compliance with policy, ICH GCP and other regulatory
requirements
Step-by-step approach
 Step 4 - Authorizing the SOPs
No SOP is a SOP without proper authorization
 Purpose is to decide on an appropriate method for a given
procedure, standardize the performance of the procedure &
communicate these decisions to everyone involved
 Most effective authorization is done by someone with organizational
influence, specialist insight and knowledge of ICH GCP
 Rational approach - let management, in its policy, mandate use
& production of SOPs
 Same policy -can delegate responsibility for authorization to
person in charge of each specialist area
 defined as ‘management ’in this special context
 Departmental SOPs then specify which named individuals are
empowered to authorize SOP’s in their area
Step-by-step approach
 Step 5 - Distributing & Archiving the SOPs
Each dept or for that matter section (e .g sponsor ’site or Trial site) administers its own
collection of SOPs & must identify (by the management) who is responsible for their
distribution and withdrawal
 Responsibility for typing and copying of SOPs will depend on capacity in different depts
 When requisite no. of SOPs have been produced, before distribution, they should be
stamped ‘DO NOT COPY’ and ‘CONTROLLED COPY’ with coloured stamp, or some other
technique to distinguish between the original from photocopied versions.
 original SOP should be kept by QA or a responsible management representative in a
secure place

 Historical or expired SOPs whose new versions have been issued - properly
archived with ‘ARCHIVED’ stamp on original SOP
 Should be kept in a designated place with controlled entry called ‘Archives’
 can be retrieved from the ‘Archives’ for the purpose of reference or audit
whenever reqd with a proper documentation and the SOPs should be re-
archived after the job is finished.
 A management designated person called ‘Archivist’ should be responsible
for managing archives
 All photocopies of expired SOP - destroyed immediately after its new
version comes in effect
 to reduce confusion for staff in working by existence of 2 different methods floating
simultaneously
Step-by-step approach
 Step 6 - Training of the SOPs
Training on SOPs is often last thing that people think about once SOP is written
 When SOP goes into effect there is often a great sense of relief
 frequently case that staff does not receive adequate training on the SOPs-
purpose of SOPs - remains unfulfilled
 QA/ Monitors / CR Managers & management should see to it that there is
continuous training of SOPs among staff
 trainings should be documented properly and all records - training log must
be maintained in the staff training record
 effective date - must be 2-3 days after it is authorized
 Give sufficient time for staff to read & understand the SOP before it is

actually implemented in system.


 effective date should be clearly specified - so that staff is aware of it

 Also staff training on FDA’s 21 CFR Part 11 and related guidelines on


electronic records should be undertaken
 Formal and continuous training sessions should be taken by the QAU, CRA
and CR Managers
 increase SOP awareness among staff and also continuous review will help
in amending SOP, if reqd
Step-by-step approach
 Step 7 - Alterations in SOPs
When a mistake in an SOP is found, it is tempting to alter the text by
hand
 especially tempting when the SOP is newly issued or if the change is
only in the distribution list
 Such alterations are dangerous as no one knows
 whether comments appear in all SOPs of that edition
 how long they have existed there
 whether anyone has modified their working routine as a result, or
whether data has been compromised
 Detection of such actions must prompt inquiry- if alteration is
necessary- will need to update
 electronic SOPs- must be a secured system of change control and
rights to modify SOPs should be properly reflected in audit trail
 procedure of updating a SOP must reflect in the appropriate SOP both
electronically and manually (if practiced)
Step-by-step approach
 Step 8 - Reviews of SOPs

 should be regularly reviewed and updated to ensure that they


encourage efficient working practices that comply with the ever
increasing requirements, improvements and government
regulatory framework that have to operate within
 Prudent for management to introduce a scheme for automatic
review - date of next review should be reflected
 so that everybody is aware of next review date and are ready
with their suggestions and improvements
 If no changes are necessary this decision should be
recorded but still version no. should be changed to reflect
that review did happen
Parties in a Clinical Trial

Investigator Patient

Clinical
Trial

Regulatory Ethics
Authorities Committee

Sponsor
The End………

Thanks for the Attention…….

Pl feel free to discuss or ask


questions
Extra Slides

Вам также может понравиться