CRP Research Project Management & Coordination Flashcards

Which document formally authorizes a research coordinator to conduct a clinical study at a site?

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.

What is the primary purpose of a study initiation visit (SIV)?

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.

A delegation of authority log in clinical research is used to:

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.

What is the standard Good Clinical Practice (GCP) requirement for correcting an error in a paper case report form (CRF)?

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.

What does 'screen failure' mean in clinical research project management?

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.

Which regulatory document must a research coordinator maintain to verify a participant actually received the investigational product as specified?

Answer: The drug/device accountability log

The drug or device accountability log tracks dispensing, returns, and destruction of investigational products to verify protocol compliance.