CCRC EXAM | NEW 2026 UPDATE | QUESTIONS AND
ANSWERS | 100% CORRECT
This phase determines therapeutic benefit and is usually done in a larger,
specific population. Answer - Phase 3
The purpose of source documentation is Answer - To verify that the date in
case report forms are consistent with that in the source documents
(ICH E6 sec 8.3.13)
What is the minimum number of members on an IRB/IEC Answer - 5
(ICH E6 sec 3.2.1)
When should the contractual agreement between the sponsor and the
investigator be signed? Answer - Before the trial
(ICH E6 sec 4.5)
Most typical study, investigates human pharmacology. It is the initial
administration or an investigational new drug into humans. It is most
commonly done in healthy subjects. Answer - Phase 1
(ICH E6 sec 3.1.3.1)
The World Medical Association (WMA) ethical principles for medical research
involving human subjects is called: Answer - The Declaration of Helsinki
, What is the purpose of ICH-GCP Answer - To standardize the design, conduct,
recording, and reporting of clinical trials
(ICH E6 sec 3.1.1)
What is the purpose of the IRB/IEC Answer - To protect subject safety
(ICH E6 sec 3.1.1)
Who is ultimately responsible for Source Data Verification (SDV) Answer - The
monitor
(ICH E6 sec 5.18.4)
Therapeutic use. Begins after drug approval. Answer - Phase 4
(ICH E8 sec 3.1.3.4)
Essential documents are Answer - Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the
data produced.
(ICH E6 sec 1.23)
What does the IRB/IEC evaluate Answer - The scientific tenability of the trial
What is the purpose of the initiation visit? Answer - 1. To review the protocol
2. To review standard procedures
3. To review the blank Case Report Forms (CRFs)
(ICH E6 sec 8.2.20)
According to ICH, the abbreviation 'LAR' stands for 'Legally authorized
representative' Answer - False
ANSWERS | 100% CORRECT
This phase determines therapeutic benefit and is usually done in a larger,
specific population. Answer - Phase 3
The purpose of source documentation is Answer - To verify that the date in
case report forms are consistent with that in the source documents
(ICH E6 sec 8.3.13)
What is the minimum number of members on an IRB/IEC Answer - 5
(ICH E6 sec 3.2.1)
When should the contractual agreement between the sponsor and the
investigator be signed? Answer - Before the trial
(ICH E6 sec 4.5)
Most typical study, investigates human pharmacology. It is the initial
administration or an investigational new drug into humans. It is most
commonly done in healthy subjects. Answer - Phase 1
(ICH E6 sec 3.1.3.1)
The World Medical Association (WMA) ethical principles for medical research
involving human subjects is called: Answer - The Declaration of Helsinki
, What is the purpose of ICH-GCP Answer - To standardize the design, conduct,
recording, and reporting of clinical trials
(ICH E6 sec 3.1.1)
What is the purpose of the IRB/IEC Answer - To protect subject safety
(ICH E6 sec 3.1.1)
Who is ultimately responsible for Source Data Verification (SDV) Answer - The
monitor
(ICH E6 sec 5.18.4)
Therapeutic use. Begins after drug approval. Answer - Phase 4
(ICH E8 sec 3.1.3.4)
Essential documents are Answer - Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the
data produced.
(ICH E6 sec 1.23)
What does the IRB/IEC evaluate Answer - The scientific tenability of the trial
What is the purpose of the initiation visit? Answer - 1. To review the protocol
2. To review standard procedures
3. To review the blank Case Report Forms (CRFs)
(ICH E6 sec 8.2.20)
According to ICH, the abbreviation 'LAR' stands for 'Legally authorized
representative' Answer - False
