CCRC Exam 03-19-2024-2025
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 - answer5
(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: - answerThe Declaration of Helsinki
What is the purpose of ICH-GCP - answerTo standardize the design, conduct,
recording, and reporting of clinical trials
(ICH E6 sec 3.1.1)
What is the purpose of the IRB/IEC - answerTo protect subject safety
(ICH E6 sec 3.1.1)
Who is ultimately responsible for Source Data Verification (SDV) - answerThe monitor
(ICH E6 sec 5.18.4)
Therapeutic use. Begins after drug approval. - answerPhase 4
(ICH E8 sec 3.1.3.4)
Essential documents are - answerDocuments 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 - answerThe scientific tenability of the trial
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 - answer5
(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: - answerThe Declaration of Helsinki
What is the purpose of ICH-GCP - answerTo standardize the design, conduct,
recording, and reporting of clinical trials
(ICH E6 sec 3.1.1)
What is the purpose of the IRB/IEC - answerTo protect subject safety
(ICH E6 sec 3.1.1)
Who is ultimately responsible for Source Data Verification (SDV) - answerThe monitor
(ICH E6 sec 5.18.4)
Therapeutic use. Begins after drug approval. - answerPhase 4
(ICH E8 sec 3.1.3.4)
Essential documents are - answerDocuments 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 - answerThe scientific tenability of the trial
