CCDM EXAM REVIEW QUESTIONS WITH
ACCURATE SOLUTIONS 2026
▶ Data Module. Answer: A category of a type of data (ie.CRF)
▶ Database Backup. Answer: Duplicate copy of all electronic data and
Metadata that can be retrieved in the event of system failure or data
corruption.
▶ Database Lock. Answer: The closing of a database after all clinical trial
data has been reviewed, queries resolved and issues addressed, such that
it can't be altered.
▶ Development/test Environment. Answer: Computer system instances
used for study built and UAT, prior to release to the production instance.
Defined quality procedures and documentation allow transition of
programming code from one instance to another.
▶ Direct Access. Answer: Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a
clinical trial.
▶ Disaster Recovery Plan. Answer: a comprehensive statement of all
actions to be taken before, during, and after a disaster, along with
documented, tested procedures that will ensure the continuity of operations
and availability of critical resources in event of disaster.
▶ Discrepancy. Answer: Inconsistency in 2+ data points collected in a
clinical trial the must be addressed prior to DBL.
▶ Documentation. Answer: All records, in any form (including, but not
limited to, written, electronic, magnetic, and optical records, and scans, x-
rays, and electrocardiograms) that describe or record the methods,
conduct, and/or results of a trial, the factors affecting a trial, and the actions
taken.
ACCURATE SOLUTIONS 2026
▶ Data Module. Answer: A category of a type of data (ie.CRF)
▶ Database Backup. Answer: Duplicate copy of all electronic data and
Metadata that can be retrieved in the event of system failure or data
corruption.
▶ Database Lock. Answer: The closing of a database after all clinical trial
data has been reviewed, queries resolved and issues addressed, such that
it can't be altered.
▶ Development/test Environment. Answer: Computer system instances
used for study built and UAT, prior to release to the production instance.
Defined quality procedures and documentation allow transition of
programming code from one instance to another.
▶ Direct Access. Answer: Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a
clinical trial.
▶ Disaster Recovery Plan. Answer: a comprehensive statement of all
actions to be taken before, during, and after a disaster, along with
documented, tested procedures that will ensure the continuity of operations
and availability of critical resources in event of disaster.
▶ Discrepancy. Answer: Inconsistency in 2+ data points collected in a
clinical trial the must be addressed prior to DBL.
▶ Documentation. Answer: All records, in any form (including, but not
limited to, written, electronic, magnetic, and optical records, and scans, x-
rays, and electrocardiograms) that describe or record the methods,
conduct, and/or results of a trial, the factors affecting a trial, and the actions
taken.
