CLINICAL DATA MANAGMENT

Q. What is Clinical Data Management?

A. It is the process of managing data arising out of trials conducted on human subjects before a drug is launched in
the market. It is an integral part of clinical trials and involves collection, integration and validation of data.

Q. What is the eligibility for a career in Clinical Data Management?

A. Graduates and post graduates in life sciences (pharmacy, medicine and bio-sciences with any of the following
subjects like botany, zoology, chemistry, organic chemistry, biochemistry, microbiology, genetics, bio-technology,
BAMS, BHMS), nurses, doctors, medical transcriptionists, biostatisticians, and medical representatives are all
eligible.

Q. What initial salary can I expect as a CDM professional?

A. Starting salaries for Clinical Data Management professions are approximately 2.5 lacs for persons without work
experience. With a year or more of work experience this figure can start at 3 lacs.

Q. What are my career prospects?

A. Depending on your individual interests and skills you may be eligible for, or grow into, any of the following
positions: Clinical Data Processors, Data Validation Associates, Clinical Data Managers/Coordinators, CRF
Developers, Medical Coders, Clinical data base designers, Data Management Team Lead, Project Manager, Lead
Data Manager and so on.

Q. Why are life science graduates and post graduates preferred for the CDM
industry?
A. This is because they have the required domain knowledge and understanding of clinical terminologies that saves
companies time and money on training new entrants.

Q. Which companies recruit Clinical Data Management professionals?

A. You would be eligible for jobs available within the CDM division of top pharmaceutical companies like Novartis,
Contract Research Organizations like Quintiles, Parexel, Manipal Acunova and ICON and KPOs like Accenture,
Cognizant and Tata Consultancy Services.
Q.

Does this job involve a lot of travelling?

A. It generally does not involve travelling since it is an in-house job.

Q. Will I have to work in shifts?

A. Many companies work regular general shifts, however it will depend on the specific company and project in which
you are involved.
Q. Do

I need to know computer programming to make a career in CDM?

A. Clinical Data Management is an allied science; computer programming is not a requirement. Basic understanding
of clinical research fundamentals and thorough knowledge of CDM processes is however required.

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Q. What is SAS? Do I need to learn it?

A. SAS (Statistical Analysis System) is the de facto standard for data analysis. You would need to learn SAS if you
wish to enter the clinical data analysis domain. For clinical data management, it isnt a necessity.
Q. What

is Oracle Clinical?

A. Oracle Clinical is a product of Oracle Corp. This was the first ever application to streamline the process
management of data generated in clinical trials. It is now the de-facto standard for Clinical data management and has
functionality built in for all necessary processes.
Q. What

other clinical applications do I need to know for entry into CDM?

A. Working/Functional knowledge of at least one Clinical Data Management system (CDMS) such as Oracle Clinical
is sufficient to be eligible for any jobs in CDM. Hence working on projects which use any such software would result in
a much more comprehensive learning that would increase your chances of being hired.

Q. What kinds of deliverables is the data management team expected to deliver at

the end of the study?
A. It really depends on the type of study, but generally, the following are data management deliverables that you
should deliver for the overall Trial Master File (TMF):
Item #
1.
2.
3.
4.
5.
6.

7.

8.
9.
10.

Data Management Deliverable Description

Blank Case Report Forms and Data Entry Guidelines (All approved versions )
Data management plan (all approved versions)
Database specifications (all approved versions)
Database training records (all database users)
User Access Records (all database users)
Database production release documentation (all releases including database change requests)
Data cleaning records
a. Resolved queries
b. Medical coding approval
c. Quality control evaluation approval
d. SAE reconciliation approval
Database lock and/Un-lock approval(s)
Final RAW data extract
Completed CRFs and related audit trail report(s)

Q: What are the requirements of 21 CFR 11?

A: 21 CFR 11 requires that closed computer systems must have a collection of technological and
procedural controls to protect data within the system. Open computer systems must also include
controls to ensure that all records are authentic, incorruptible, and (where applicable) confidential.
Q: What computer systems must be compliant with 21 CFR 11?
A: All computer systems which store data which is used to make Quality decisions or data which will
be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any
laboratory results used to determine quality, safety, strength, efficacy, or purity. In clinical
environments, this includes all data to be reported as part of the clinical trial used to determine
quality, safety, or efficacy. In manufacturing environments, this includes all decisions related to
product release and product quality.

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Q: What is computer system validation?
A: Validation is a systematic documentation of system requirements, combined with documented
testing, demonstrating that the computer system meets the documented requirements. It is the first
requirement identified in 21 CFR 11 for compliance. Validation requires that the System Owner
maintain the collection of validation documents, including Requirement Specifications and Testing
Protocols.
Q: What is accurate record generation?
A: Accurate record generation means that records entered into the system must be completely
retrievable without unexpected alteration or unrecorded changes. This is generally tested by
verifying that records entered into the system must be accurately displayed and accurately exported
from the system.

Q: How must records be protected?

A: Electronic records must not be corrupted and must be readily accessible throughout the record
retention period. This is usually performed through a combination of technological and procedural
controls.
Q: What is limited system access?
A: System owners must demonstrate that they know who is accessing and altering their system
data. When controlled technologically, this is commonly demonstrated by requiring all users have
unique user IDs along with passwords to enter the system.
Q: What is an audit trail?
A: An audit trail is an internal log in a program that records all changes to system data. This is tested
by demonstrating that all changes made to data are recorded to the audit trail.
Q: What are operational system checks?
A: Operational system checks enforce sequencing of critical system functionality. This is
demonstrated by showing that business-defined workflows must be followed. For example, data
must be entered before it can be reviewed.
Q: What are device checks?
A: Device checks are tests to ensure the validity of data inputs and operational instructions.
Generally speaking, Systems does not suggest testing keyboards, mice, etc., because these input
devices are implicitly tested throughout other testing. However, if particular input devices (optical
scanners, laboratory equipment, etc.) these devices should be tested to ensure the accuracy of
system inputs.
Q: What training requirements are required for 21 CFR 11 compliant programs?
A: Users must be documented to have the education, training, and experience to use the computer
system. Typically training can be covered by your company training procedures.

Q: What is a policy of responsibility for using electronic signatures?

A: Users must state that they are aware that they are responsible for all data they enter or edit in a
system. This can be accomplished technologically through accepting conditions upon signing into
the system or procedurally by documenting this responsibility as part of training.

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Q: What documentation requirements are required for 21 CFR 11 compliant programs?
A: Documentation must exist which defines system operations and maintenance. Typically these
requirements are met by company document control procedures.
Q: What are the requirements for electronic signatures?
A: All electronic signatures must:
Include the printed name of the signer, the date/time the signature was applied, and the meaning
of the electronic signature.
Be included in human readable form of the record. Electronic signatures must not be separable
from their record.
Must be unique to a single user and not used by anyone else.
Can use biometrics to uniquely identify the user. If biometrics are not used, they need at least two
distinct identifiers (for example, the user ID and a secret password).

Q: Does 21 CFR 11 have any requirements for passwords or identification codes?

A: Yes. Procedural controls should exists to ensure that:
No two individuals have the same user ID and password.
Passwords are periodically checked and expire.
Loss management procedures exists to de-authorize lost, stolen, or missing passwords.

Downloads
21 CFR 11 Help An executable help file with the complete text of 21 CFR 11. A good introduction
to electronic compliance.

Glossary
Closed Systems are computer systems where system access is controlled by people who are
responsible for the content of electronic records in the system. Most applications are considered
to be closed systems.
Open Systems are computer systems where system access is not controlled by people
responsible for the content of electronic records in the system. The internet or wikis are examples
of open systems.
Procedural Controls are documented SOPs which ensure that a system is only used in a
particular manner.
Technological Controls are program-enforced compliance rules, like requiring that a user have
a password to log into a computer system. Technological controls are generally considered to be
more secure than procedural controls.

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Biometrics are means of identifying a person based on physical characteristics or repeatable
actions. Some examples of biometrics include identifying a user based on a physical signature,
fingerprints, etc.

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