(GCDMP) Good Clinical Data Management Practices
(Oct. 2013 Edition) - Questions With Clear Solutions
Why was the SCDM non-profit professional organization created? Right
Ans - To advance discipline of clinical data management.
What purposes was the SCDM created? Right Ans - educational and
scientific purposes
What is the purpose of the CGDMP document? Right Ans - To provide
guidance on accepted practices not covered by regulatory/guidance docs
Why must privacy of subjects of clinical trials be protected? Right Ans -
Ethical and legal reasons
What is data privacy? Right Ans - Refers to standards surrounding
protection of personal data (anything that can lead to ID directly or indirectly
of a subject, ex. names, initials, addresses, geneteics)
What are the 5 privacy protection afforded to research subjects? Right Ans
- Protocol review/approval by IRB, right to inform consent, right to withdraw
consent, right to notice of disclosure, confidential collection/submission of
data
Who should be trained on handling identifiable personal data? Right Ans -
All personnel (including vendors)
What is the minimum SOPs regarding data privacy? Right Ans - At
minimum they should comply with all regulations of the study's locations
Who's role has a narrower focus: investigator site or data manager? Right
Ans - Data manager. But they still need to ensure data privacy is maintained
Why do EU and US have legislation and guidance documents that have a
higher impact on clinical research than other countries? Right Ans - EU and
US are involved in higher volume of clinical research
,Can members of the EU transfer personal data anywhere? Right Ans - No
they can only transfer data to countries with "adequacy determination" from
the EU commission
How does adequacy determination work in the US? Right Ans - Companies
can have it, instead of countries
What are Safe Harbor Principles? Right Ans - Process for US companies to
acquire adequacy determination (must recertify every 12 mo.)
What are the 7 things companies must have according to Safe Harbor
principles? Right Ans - access, choice, data transfer, data integrity,
enforcement, notice, security. Access- can access info/corrected/deleted if
needed; Choice- opt out of data collection/transfer; Data integrity- Must be
reliable and relevant to original purpose; Data transfer- data only transferred
to 3rd parties with rigorous data protection policies; Enforcement- how rules
will be enforced; Notice- subjects must know how data will be collected/used;
Security- don't lose data collected
What is personal data? Right Ans - Any info related to an identified or
identifiable natural person
What should be done before a data transfer? Right Ans - A data transfer
specification document should be produced to identify the secure method of
transfer
What is the ultimate subject identifier? Right Ans - DNA
Difference in security needed for EDC and ePRO studies? Right Ans - EDC-
automatic user logout, ePRO- training subjects on use of device and give them
passwords
What regulations should international studies adhere to? Right Ans - Most
restrictive regulations of countries involved
What should happen before data collection begins? Right Ans - All studies
should have a DMP or SAP
,When should the DMP be created? Right Ans - Prior to enrollment of first
subject and should be finalized before work it describes
What is the primary goal of the DMP? Right Ans - communicate to all
stakeholders the necessary knowledge needed to create and maintain a high-
quality database
What is in the organization of a DMP? Right Ans - Approval page (needs to
be signed before work begins), protocol summary, dictionary and coding
management (which medical coding dictionary should be used), definition and
acronym, personal/role identification/training
What are the 3 CRF related things that the DMP or related doc should define?
Right Ans - CRF design, instructions, and changes
What should the database security section of the DMP address? Right Ans -
Maintenance of user roles, database backup
What should the DMP provide guidance for regarding data entry or
processing? Right Ans - Data entry/processing plans... data entry
guidelines/data discrepancy guidelines, data receipt, data processing, data
entry, how to show self-evident corrections, database reconciliation, database
lock
What does DMP have to do with validation test procedures? Right Ans -
The DMP should define validation test procedures to ensure integrity of
study-specific components such as programming/algorithms, data entry/EDC
screens, online logic/data-checking routines, security, backups, and archiving
What do data quality checks include? Right Ans - Manual review specs,
discrepancy management, electronic data discrepancy management
For external data transfer, what should the DMP include? Right Ans - data
type (e.g., safety lab data), the entity providing or receiving the data and any
applicable agreements, the format, the frequency of transfers, and contact
information, procedures used for collecting/handling lab data, format of
transfer (SAS/XML), method of transfer (email, DVD)
, What are some other random things covered in the DMP? Right Ans - Audit
plan, metrics (used for the study), reports + details made throughout study,
communications
What are some other other random things? Right Ans - DSMB requirement,
business rules, flowcharts/forms, problems/resolutions, change control
processes, blind data review specs, archival/record retention processes
Is project management just being organized and being able to communicate?
Right Ans - No, much more
What are the 3 best practices of clinical data management (project
management standpoint)? Right Ans - Create responsibility matrix,
conduct regular meetings, continually assess project processes + modify as
needed
What are the 5 stages of project management? Right Ans - Initiating,
Planning, Executing, Monitoring and Controlling, and Closing
What are the 9 Knowledge Areas (PMI) Right Ans - Integration
Scope
Time
Cost
Quality
HR
Communication
Risk
Procurement
What is in the triple constraint? Right Ans - Scope, time, cost
What are the CDM tasks for initiation? Right Ans - Share and discuss with
individual(s) responsible for compiling requests for proposal the forecasted
task/resource/time requirements as assessed for the study. Define CDM
contributions to the overall study team mission statement, scope, and goals in
accordance with a funded portfolio or contract. Form or confirm core CDM
team for the study: identify data manager(s) and CDM support personnel.
(Oct. 2013 Edition) - Questions With Clear Solutions
Why was the SCDM non-profit professional organization created? Right
Ans - To advance discipline of clinical data management.
What purposes was the SCDM created? Right Ans - educational and
scientific purposes
What is the purpose of the CGDMP document? Right Ans - To provide
guidance on accepted practices not covered by regulatory/guidance docs
Why must privacy of subjects of clinical trials be protected? Right Ans -
Ethical and legal reasons
What is data privacy? Right Ans - Refers to standards surrounding
protection of personal data (anything that can lead to ID directly or indirectly
of a subject, ex. names, initials, addresses, geneteics)
What are the 5 privacy protection afforded to research subjects? Right Ans
- Protocol review/approval by IRB, right to inform consent, right to withdraw
consent, right to notice of disclosure, confidential collection/submission of
data
Who should be trained on handling identifiable personal data? Right Ans -
All personnel (including vendors)
What is the minimum SOPs regarding data privacy? Right Ans - At
minimum they should comply with all regulations of the study's locations
Who's role has a narrower focus: investigator site or data manager? Right
Ans - Data manager. But they still need to ensure data privacy is maintained
Why do EU and US have legislation and guidance documents that have a
higher impact on clinical research than other countries? Right Ans - EU and
US are involved in higher volume of clinical research
,Can members of the EU transfer personal data anywhere? Right Ans - No
they can only transfer data to countries with "adequacy determination" from
the EU commission
How does adequacy determination work in the US? Right Ans - Companies
can have it, instead of countries
What are Safe Harbor Principles? Right Ans - Process for US companies to
acquire adequacy determination (must recertify every 12 mo.)
What are the 7 things companies must have according to Safe Harbor
principles? Right Ans - access, choice, data transfer, data integrity,
enforcement, notice, security. Access- can access info/corrected/deleted if
needed; Choice- opt out of data collection/transfer; Data integrity- Must be
reliable and relevant to original purpose; Data transfer- data only transferred
to 3rd parties with rigorous data protection policies; Enforcement- how rules
will be enforced; Notice- subjects must know how data will be collected/used;
Security- don't lose data collected
What is personal data? Right Ans - Any info related to an identified or
identifiable natural person
What should be done before a data transfer? Right Ans - A data transfer
specification document should be produced to identify the secure method of
transfer
What is the ultimate subject identifier? Right Ans - DNA
Difference in security needed for EDC and ePRO studies? Right Ans - EDC-
automatic user logout, ePRO- training subjects on use of device and give them
passwords
What regulations should international studies adhere to? Right Ans - Most
restrictive regulations of countries involved
What should happen before data collection begins? Right Ans - All studies
should have a DMP or SAP
,When should the DMP be created? Right Ans - Prior to enrollment of first
subject and should be finalized before work it describes
What is the primary goal of the DMP? Right Ans - communicate to all
stakeholders the necessary knowledge needed to create and maintain a high-
quality database
What is in the organization of a DMP? Right Ans - Approval page (needs to
be signed before work begins), protocol summary, dictionary and coding
management (which medical coding dictionary should be used), definition and
acronym, personal/role identification/training
What are the 3 CRF related things that the DMP or related doc should define?
Right Ans - CRF design, instructions, and changes
What should the database security section of the DMP address? Right Ans -
Maintenance of user roles, database backup
What should the DMP provide guidance for regarding data entry or
processing? Right Ans - Data entry/processing plans... data entry
guidelines/data discrepancy guidelines, data receipt, data processing, data
entry, how to show self-evident corrections, database reconciliation, database
lock
What does DMP have to do with validation test procedures? Right Ans -
The DMP should define validation test procedures to ensure integrity of
study-specific components such as programming/algorithms, data entry/EDC
screens, online logic/data-checking routines, security, backups, and archiving
What do data quality checks include? Right Ans - Manual review specs,
discrepancy management, electronic data discrepancy management
For external data transfer, what should the DMP include? Right Ans - data
type (e.g., safety lab data), the entity providing or receiving the data and any
applicable agreements, the format, the frequency of transfers, and contact
information, procedures used for collecting/handling lab data, format of
transfer (SAS/XML), method of transfer (email, DVD)
, What are some other random things covered in the DMP? Right Ans - Audit
plan, metrics (used for the study), reports + details made throughout study,
communications
What are some other other random things? Right Ans - DSMB requirement,
business rules, flowcharts/forms, problems/resolutions, change control
processes, blind data review specs, archival/record retention processes
Is project management just being organized and being able to communicate?
Right Ans - No, much more
What are the 3 best practices of clinical data management (project
management standpoint)? Right Ans - Create responsibility matrix,
conduct regular meetings, continually assess project processes + modify as
needed
What are the 5 stages of project management? Right Ans - Initiating,
Planning, Executing, Monitoring and Controlling, and Closing
What are the 9 Knowledge Areas (PMI) Right Ans - Integration
Scope
Time
Cost
Quality
HR
Communication
Risk
Procurement
What is in the triple constraint? Right Ans - Scope, time, cost
What are the CDM tasks for initiation? Right Ans - Share and discuss with
individual(s) responsible for compiling requests for proposal the forecasted
task/resource/time requirements as assessed for the study. Define CDM
contributions to the overall study team mission statement, scope, and goals in
accordance with a funded portfolio or contract. Form or confirm core CDM
team for the study: identify data manager(s) and CDM support personnel.
