Certified Clinical Data Manager (CCDM) Practice Exam
1. Which organization offers the CCDM certification?
A) Society for Clinical Data Management (SCDM)
B) Clinical Data Interchange Standards Consortium (CDISC)
C) Association of Clinical Research Professionals (ACRP)
D) Drug Information Association (DIA)
ANSWER: A
EXPLANATION: The Society for Clinical Data Management (SCDM) offers the
CCDM certification.
2. What is the primary purpose of a Data Management Plan (DMP)?
A) Document data collection, processing, and validation procedures
B) Outline statistical analysis methods
C) Detail clinical monitoring procedures
D) Specify regulatory submission requirements
ANSWER: A
EXPLANATION: The DMP defines how clinical data will be handled throughout
the study lifecycle.
3. Which CDISC standard defines clinical trial data tabulation?
A) SDTM (Study Data Tabulation Model)
B) ADaM (Analysis Data Model)
C) CDASH (Clinical Data Acquisition Standards Harmonization)
D) SEND (Standard for Exchange of Nonclinical Data)
ANSWER: A
EXPLANATION: SDTM provides the standard structure for submitting clinical trial
data to regulatory agencies.
4. What does CFR Part 11 regulate?
A) Electronic records and electronic signatures
B) Clinical trial monitoring
C) Investigational drug storage
D) Patient informed consent
ANSWER: A
EXPLANATION: 21 CFR Part 11 sets requirements for electronic records and
signatures in FDA-regulated industries.
5. Which document defines the protocol-specified data to be collected?
A) Case Report Form (CRF)
B) Statistical Analysis Plan (SAP)
C) Clinical Study Report (CSR)
, D) Investigator's Brochure (IB)
ANSWER: A
EXPLANATION: The CRF is designed to collect protocol-specified data from
study subjects.
6. What is the purpose of a Data Validation Plan?
A) Define edit checks and validation procedures
B) Outline database structure
C) Specify user access controls
D) Document backup procedures
ANSWER: A
EXPLANATION: The validation plan defines how data quality will be ensured
through edit checks and validation procedures.
7. Which MedDRA hierarchy level is most detailed?
A) Lowest Level Term (LLT)
B) Preferred Term (PT)
C) High Level Term (HLT)
D) System Organ Class (SOC)
ANSWER: A
EXPLANATION: LLT is the most granular level in MedDRA terminology.
8. What does SAE stand for in clinical trials?
A) Serious Adverse Event
B) Significant Adverse Effect
C) Severe Adverse Experience
D) Substantial Adverse Event
ANSWER: A
EXPLANATION: SAE = Serious Adverse Event, defined by specific regulatory
criteria.
9. Which process ensures data consistency across databases?
A) Reconciliation
B) Validation
C) Transformation
D) Migration
ANSWER: A
EXPLANATION: Reconciliation ensures consistency between different data
sources (e.g., lab data vs. CRF data).
10. What is the primary goal of query management?
A) Resolve data discrepancies and inconsistencies
B) Track protocol deviations
C) Monitor patient recruitment
D) Manage site payments
, ANSWER: A
EXPLANATION: Query management resolves data issues identified during
review.
11. Which CDASH domain contains demographic data?
A) DM
B) VS
C) EX
D) CM
ANSWER: A
EXPLANATION: DM (Demographics) contains subject demographic information.
12. What does UAT stand for in system validation?
A) User Acceptance Testing
B) User Access Testing
C) Unified Acceptance Testing
D) Universal Access Testing
ANSWER: A
EXPLANATION: UAT ensures the system meets end-user requirements.
13. Which regulatory agency requires submission in CDISC standards?
A) FDA
B) EMA
C) PMDA
D) All of the above
ANSWER: D
EXPLANATION: Major regulatory agencies require or recommend CDISC
standards.
14. What is the purpose of a coding dictionary in clinical trials?
A) Standardize medical terminology
B) Calculate sample size
C) Randomize patients
D) Track shipments
ANSWER: A
EXPLANATION: Coding dictionaries (MedDRA, WHO Drug) standardize adverse
events and medications.
15. Which process converts source data to SDTM format?
A) Mapping
B) Cleaning
C) Validation
D) Archiving
ANSWER: A
1. Which organization offers the CCDM certification?
A) Society for Clinical Data Management (SCDM)
B) Clinical Data Interchange Standards Consortium (CDISC)
C) Association of Clinical Research Professionals (ACRP)
D) Drug Information Association (DIA)
ANSWER: A
EXPLANATION: The Society for Clinical Data Management (SCDM) offers the
CCDM certification.
2. What is the primary purpose of a Data Management Plan (DMP)?
A) Document data collection, processing, and validation procedures
B) Outline statistical analysis methods
C) Detail clinical monitoring procedures
D) Specify regulatory submission requirements
ANSWER: A
EXPLANATION: The DMP defines how clinical data will be handled throughout
the study lifecycle.
3. Which CDISC standard defines clinical trial data tabulation?
A) SDTM (Study Data Tabulation Model)
B) ADaM (Analysis Data Model)
C) CDASH (Clinical Data Acquisition Standards Harmonization)
D) SEND (Standard for Exchange of Nonclinical Data)
ANSWER: A
EXPLANATION: SDTM provides the standard structure for submitting clinical trial
data to regulatory agencies.
4. What does CFR Part 11 regulate?
A) Electronic records and electronic signatures
B) Clinical trial monitoring
C) Investigational drug storage
D) Patient informed consent
ANSWER: A
EXPLANATION: 21 CFR Part 11 sets requirements for electronic records and
signatures in FDA-regulated industries.
5. Which document defines the protocol-specified data to be collected?
A) Case Report Form (CRF)
B) Statistical Analysis Plan (SAP)
C) Clinical Study Report (CSR)
, D) Investigator's Brochure (IB)
ANSWER: A
EXPLANATION: The CRF is designed to collect protocol-specified data from
study subjects.
6. What is the purpose of a Data Validation Plan?
A) Define edit checks and validation procedures
B) Outline database structure
C) Specify user access controls
D) Document backup procedures
ANSWER: A
EXPLANATION: The validation plan defines how data quality will be ensured
through edit checks and validation procedures.
7. Which MedDRA hierarchy level is most detailed?
A) Lowest Level Term (LLT)
B) Preferred Term (PT)
C) High Level Term (HLT)
D) System Organ Class (SOC)
ANSWER: A
EXPLANATION: LLT is the most granular level in MedDRA terminology.
8. What does SAE stand for in clinical trials?
A) Serious Adverse Event
B) Significant Adverse Effect
C) Severe Adverse Experience
D) Substantial Adverse Event
ANSWER: A
EXPLANATION: SAE = Serious Adverse Event, defined by specific regulatory
criteria.
9. Which process ensures data consistency across databases?
A) Reconciliation
B) Validation
C) Transformation
D) Migration
ANSWER: A
EXPLANATION: Reconciliation ensures consistency between different data
sources (e.g., lab data vs. CRF data).
10. What is the primary goal of query management?
A) Resolve data discrepancies and inconsistencies
B) Track protocol deviations
C) Monitor patient recruitment
D) Manage site payments
, ANSWER: A
EXPLANATION: Query management resolves data issues identified during
review.
11. Which CDASH domain contains demographic data?
A) DM
B) VS
C) EX
D) CM
ANSWER: A
EXPLANATION: DM (Demographics) contains subject demographic information.
12. What does UAT stand for in system validation?
A) User Acceptance Testing
B) User Access Testing
C) Unified Acceptance Testing
D) Universal Access Testing
ANSWER: A
EXPLANATION: UAT ensures the system meets end-user requirements.
13. Which regulatory agency requires submission in CDISC standards?
A) FDA
B) EMA
C) PMDA
D) All of the above
ANSWER: D
EXPLANATION: Major regulatory agencies require or recommend CDISC
standards.
14. What is the purpose of a coding dictionary in clinical trials?
A) Standardize medical terminology
B) Calculate sample size
C) Randomize patients
D) Track shipments
ANSWER: A
EXPLANATION: Coding dictionaries (MedDRA, WHO Drug) standardize adverse
events and medications.
15. Which process converts source data to SDTM format?
A) Mapping
B) Cleaning
C) Validation
D) Archiving
ANSWER: A
