CRP CRP Research Project Management & Coordination 1 — Questions and Answers
Question 1: Which document formally authorizes a research coordinator to conduct a clinical study at a site?
- The sponsor's invoice
- The executed clinical trial agreement and IRB approval letter (Correct answer)
- The principal investigator's CV
- The DUNS number registration
Correct answer: The executed clinical trial agreement and IRB approval letter
An executed clinical trial agreement plus IRB approval together formally authorize a site to initiate a study.
Question 2: What is the primary purpose of a study initiation visit (SIV)?
- To enroll the first participants
- To train site staff on protocol requirements, procedures, and regulatory expectations (Correct answer)
- To submit the annual IRB progress report
- To audit the site's financial records
Correct answer: To train site staff on protocol requirements, procedures, and regulatory expectations
The SIV ensures site staff are trained on the protocol and understand their regulatory obligations before enrollment begins.
Question 3: A delegation of authority log in clinical research is used to:
- Track IRB submissions
- Document which tasks each qualified study team member is authorized to perform (Correct answer)
- Record adverse events
- List study participants by ID number
Correct answer: Document which tasks each qualified study team member is authorized to perform
The delegation log documents each team member's assigned responsibilities and confirms they are qualified to perform those tasks.
Question 4: What is the standard Good Clinical Practice (GCP) requirement for correcting an error in a paper case report form (CRF)?
- Use correction fluid (white-out) to cover the error
- Draw a single line through the error, write the correction, date, and initial (Correct answer)
- Destroy the form and create a new one
- Leave the error and attach a separate note
Correct answer: Draw a single line through the error, write the correction, date, and initial
GCP requires a single line through errors with the correction, date, and initials so the original entry remains legible.
Question 5: What does 'screen failure' mean in clinical research project management?
- A participant who completes the study without adverse events
- A potential participant who is evaluated but does not meet eligibility criteria (Correct answer)
- An IRB rejection of a protocol amendment
- A failed data quality check
Correct answer: A potential participant who is evaluated but does not meet eligibility criteria
A screen failure refers to a potential participant who was assessed for eligibility but did not qualify to enroll in the study.
Question 6: Which regulatory document must a research coordinator maintain to verify a participant actually received the investigational product as specified?
- The delegation of authority log
- The drug/device accountability log (Correct answer)
- The IRB approval letter
- The site feasibility questionnaire
Correct answer: The drug/device accountability log
The drug or device accountability log tracks dispensing, returns, and destruction of investigational products to verify protocol compliance.
CRP CRP Research Project Management & Coordination 1
Which document formally authorizes a research coordinator to conduct a clinical study at a site?