Proficiency Test 3 – Study Guide with Key Concepts and
Practice Questions
three important challenges related to the use of electronic systems in clinical research - correct
answer ✔✔ 1. managing a multitude of systems
2. ensuring access by all parties involved
3. need for a help desk on a global scale
European Medicines Agency (EMA)
United States Food and Drug Administration (U.S. FDA)
Clinical Data Interchange Standards Consortium (CDISC) - correct answer ✔✔ EMA:
- The regulatory agency for the EU
-Published a reflection paper to bring out the expectations for electronic source data
transcribed to electronic data collection tools in clinical trials
-"With increasing use of information technology in pharmaceutical development there is a need
to have clear guidance on the use of electronic source data and transcribed data and the
principles that should apply to them. This is necessary in order to ensure that the processes can
be used and accepted with confidence when such requirements are complied with, and that the
benefits that these systems offer can be fully utilized."
- investigators and their institituion including their laboratories and other technical deprtments
or clinics, generate the data and construct the record, and may use their own software or
hardware that are purchased, that are a part of natinal or institutional health information
systems, or locally developed
- investgiators and their institutions (when capturing and handling electronic data, the
responisibilities should be as defined in GCP in order to ensure relibility of data)
,-sponsors supply and/or mange and operate electronic recording systems (including software
and instruments) and the electronic records generated by these systems. The sponsors may do
this directly, or via CROs, IVRS specialists, or third-party data vendors that collect and store data
on behalf of sponsors or other service providers
FDA:
- described the use of computerized systems in clinical investigation. Also addresses the
importance of electronic systems having data element identifiers attached to each data element
as part of an electronic systems capability. this inlcudes what we know as "audit trail" , but it is
best understood as infomraiton in the system that can tell: who entered the data? who
generated teh data? when wer
Source Data
Important Attributes of Source Data: ALCOA-CCEA - correct answer ✔✔ Reporting, analysis,
verifying
confirms, quality control, integrity of data during an audit or inspection
A number of attributes are considered of universal importance to source data and the records
that hold those data. These include that the data and records are: Accurate (A) Legible (L)
Contemporaneous (C) Original (O) Attributable (A) Complete (C) Consistent (C) Enduring (E)
Available when needed (A) These are summarized as 'ALCOA-CCEA.' These elements are also
addressed in ICH GCP E6 1.51, 1.52, 4.9.1, and 6.4.9. GCP requires that sponsors operating such
systems validate the system, maintain SOPs for the use of the system, maintain an audit trail of
data changes ensuring that there is no deletion of entered data, maintain a security system to
protect against unauthorized access, maintain a list of the individuals authorized to make data
changes, maintain adequate backup of the data, protect the blinding of the study and archiving
of any source data. If data are transformed during processing, it should always be possible to
compare the original data and observations with the processed data. There should be no loss of
quality when an electronic system is used in place of a paper system.
,CDISC 12 user requirements - correct answer ✔✔ Requirement 1: An instrument used to
capture source data shall ensure that the data are
captured as specified within the protocol.
Requirement 2: Source data shall be Accurate, Legible, Contemporaneous, Original,
Attributable,
Complete and Consistent.
Requirement 3: An audit trail shall be maintained as part of the source documents for the
original creation and subsequent modification of all source data.
Requirement 4: The storage of source documents shall provide for their ready retrieval.
Requirement 5: The investigator shall maintain the original source document or a certified copy.
Requirement 6: Source data shall only be modified with the knowledge or approval of the
investigator.
Requirement 7: Source documents and data shall be protected from destruction.
Requirement 8: The source document shall allow for accurate copies to be made.
Requirement 9: Source documents shall be protected against unauthorized access.
The tenth requirement is related to the FDA 21 CFR Part 11 regulation.
Requirement 10: The sponsor shall not have exclusive control of a source document.
Requirement 11: The location of source documents and the associated source data shall be
clearly identified at all points within the capture process.
Requirement 12: When source data are copied, the process used shall ensure that the copy is an
exact copy preserving all of the data and metadata of the original.
captured as specified within the protocol.
Requirement 2: Source data shall be Accurate, Legible, Contemporaneous, Original,
Attributable,
Complete and Consistent.
Requirement 3: An audit trail shall be maintained as part of the source documents for the
original creation and subsequent modification of all source data.
, Requirement 4: The storage of source documents shall provide for their ready retrieval.
Requirement 5: The investigator shall maint
aspect to be considered when develpoing electronic systems - correct answer ✔✔ 1. creation
and modification of systems
2. creation, modification, transfer data
3. control
4. copying
5.storgage
Key Areas for Consideration in Development and Use of Electronic Systems 1: Creation and
modification of systems An instrument used to capture source data should ensure that the data
are captured as specified within the protocol. (ICH GCP E6 2.6 and 6.4.9) An instrument used to
generate, capture, transfer, manipulate or store data (e.g. Case Report Form (CRF), patient diary,
site-designed worksheet) should be an accurate representation of the protocol ensuring that
the data as specified within the protocol can be captured correctly and that the investigator or
subject response is not biased by default values present within the instrument. The instrument
should be created in a controlled manner to ensure that it conforms to the protocol and is
validated. 2: Creation, modification and transfer of data Source data should be Accurate,
Legible, Contemporaneous, Original, Attributable, Complete and Consistent as previously
discussed An audit trail should be maintained as part of the source documents for the original
creation and subsequent modification of all source data. (ICH GCP E6 4.9.3 and 5.5.4) The
location of source documents and the associated source data should be clearly identified at all
points within the capture process. (ICH GCP E6 6.4.9) 3: Control The investigator should
maintain the original source document or a certified copy. (ICH GCP E6 2.11, 5.15.1) Source data
should only be modified with the knowledge or approval of the investigator. (ICH GCP E6 4.9.3,
4.9.4 and chapter 8) The sponsor should not have exclusive control of a source document. (ICH
GCP E6 8.3.13) Source documents should be protected against unauthorized access. (ICH GCP
E6 2.11, 5.15.1) 4: Copying The source document should all
regulation and guidance - correct answer ✔✔ 1. validate the system
2. maintain sops for the use of the system
Practice Questions
three important challenges related to the use of electronic systems in clinical research - correct
answer ✔✔ 1. managing a multitude of systems
2. ensuring access by all parties involved
3. need for a help desk on a global scale
European Medicines Agency (EMA)
United States Food and Drug Administration (U.S. FDA)
Clinical Data Interchange Standards Consortium (CDISC) - correct answer ✔✔ EMA:
- The regulatory agency for the EU
-Published a reflection paper to bring out the expectations for electronic source data
transcribed to electronic data collection tools in clinical trials
-"With increasing use of information technology in pharmaceutical development there is a need
to have clear guidance on the use of electronic source data and transcribed data and the
principles that should apply to them. This is necessary in order to ensure that the processes can
be used and accepted with confidence when such requirements are complied with, and that the
benefits that these systems offer can be fully utilized."
- investigators and their institituion including their laboratories and other technical deprtments
or clinics, generate the data and construct the record, and may use their own software or
hardware that are purchased, that are a part of natinal or institutional health information
systems, or locally developed
- investgiators and their institutions (when capturing and handling electronic data, the
responisibilities should be as defined in GCP in order to ensure relibility of data)
,-sponsors supply and/or mange and operate electronic recording systems (including software
and instruments) and the electronic records generated by these systems. The sponsors may do
this directly, or via CROs, IVRS specialists, or third-party data vendors that collect and store data
on behalf of sponsors or other service providers
FDA:
- described the use of computerized systems in clinical investigation. Also addresses the
importance of electronic systems having data element identifiers attached to each data element
as part of an electronic systems capability. this inlcudes what we know as "audit trail" , but it is
best understood as infomraiton in the system that can tell: who entered the data? who
generated teh data? when wer
Source Data
Important Attributes of Source Data: ALCOA-CCEA - correct answer ✔✔ Reporting, analysis,
verifying
confirms, quality control, integrity of data during an audit or inspection
A number of attributes are considered of universal importance to source data and the records
that hold those data. These include that the data and records are: Accurate (A) Legible (L)
Contemporaneous (C) Original (O) Attributable (A) Complete (C) Consistent (C) Enduring (E)
Available when needed (A) These are summarized as 'ALCOA-CCEA.' These elements are also
addressed in ICH GCP E6 1.51, 1.52, 4.9.1, and 6.4.9. GCP requires that sponsors operating such
systems validate the system, maintain SOPs for the use of the system, maintain an audit trail of
data changes ensuring that there is no deletion of entered data, maintain a security system to
protect against unauthorized access, maintain a list of the individuals authorized to make data
changes, maintain adequate backup of the data, protect the blinding of the study and archiving
of any source data. If data are transformed during processing, it should always be possible to
compare the original data and observations with the processed data. There should be no loss of
quality when an electronic system is used in place of a paper system.
,CDISC 12 user requirements - correct answer ✔✔ Requirement 1: An instrument used to
capture source data shall ensure that the data are
captured as specified within the protocol.
Requirement 2: Source data shall be Accurate, Legible, Contemporaneous, Original,
Attributable,
Complete and Consistent.
Requirement 3: An audit trail shall be maintained as part of the source documents for the
original creation and subsequent modification of all source data.
Requirement 4: The storage of source documents shall provide for their ready retrieval.
Requirement 5: The investigator shall maintain the original source document or a certified copy.
Requirement 6: Source data shall only be modified with the knowledge or approval of the
investigator.
Requirement 7: Source documents and data shall be protected from destruction.
Requirement 8: The source document shall allow for accurate copies to be made.
Requirement 9: Source documents shall be protected against unauthorized access.
The tenth requirement is related to the FDA 21 CFR Part 11 regulation.
Requirement 10: The sponsor shall not have exclusive control of a source document.
Requirement 11: The location of source documents and the associated source data shall be
clearly identified at all points within the capture process.
Requirement 12: When source data are copied, the process used shall ensure that the copy is an
exact copy preserving all of the data and metadata of the original.
captured as specified within the protocol.
Requirement 2: Source data shall be Accurate, Legible, Contemporaneous, Original,
Attributable,
Complete and Consistent.
Requirement 3: An audit trail shall be maintained as part of the source documents for the
original creation and subsequent modification of all source data.
, Requirement 4: The storage of source documents shall provide for their ready retrieval.
Requirement 5: The investigator shall maint
aspect to be considered when develpoing electronic systems - correct answer ✔✔ 1. creation
and modification of systems
2. creation, modification, transfer data
3. control
4. copying
5.storgage
Key Areas for Consideration in Development and Use of Electronic Systems 1: Creation and
modification of systems An instrument used to capture source data should ensure that the data
are captured as specified within the protocol. (ICH GCP E6 2.6 and 6.4.9) An instrument used to
generate, capture, transfer, manipulate or store data (e.g. Case Report Form (CRF), patient diary,
site-designed worksheet) should be an accurate representation of the protocol ensuring that
the data as specified within the protocol can be captured correctly and that the investigator or
subject response is not biased by default values present within the instrument. The instrument
should be created in a controlled manner to ensure that it conforms to the protocol and is
validated. 2: Creation, modification and transfer of data Source data should be Accurate,
Legible, Contemporaneous, Original, Attributable, Complete and Consistent as previously
discussed An audit trail should be maintained as part of the source documents for the original
creation and subsequent modification of all source data. (ICH GCP E6 4.9.3 and 5.5.4) The
location of source documents and the associated source data should be clearly identified at all
points within the capture process. (ICH GCP E6 6.4.9) 3: Control The investigator should
maintain the original source document or a certified copy. (ICH GCP E6 2.11, 5.15.1) Source data
should only be modified with the knowledge or approval of the investigator. (ICH GCP E6 4.9.3,
4.9.4 and chapter 8) The sponsor should not have exclusive control of a source document. (ICH
GCP E6 8.3.13) Source documents should be protected against unauthorized access. (ICH GCP
E6 2.11, 5.15.1) 4: Copying The source document should all
regulation and guidance - correct answer ✔✔ 1. validate the system
2. maintain sops for the use of the system
