CRP CRP Research Project Management & Coordination

Question 1

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

Accepted Answer

The executed clinical trial agreement and IRB approval letter

Answer

The sponsor's invoice

Answer

The principal investigator's CV

Answer

The DUNS number registration

Question 2

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

Accepted Answer

To train site staff on protocol requirements, procedures, and regulatory expectations

Answer

To enroll the first participants

Answer

To submit the annual IRB progress report

Answer

To audit the site's financial records

Question 3

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

Accepted Answer

Document which tasks each qualified study team member is authorized to perform

Answer

Track IRB submissions

Answer

Record adverse events

Answer

List study participants by ID number

Question 4

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

Accepted Answer

Draw a single line through the error, write the correction, date, and initial

Answer

Use correction fluid (white-out) to cover the error

Answer

Destroy the form and create a new one

Answer

Leave the error and attach a separate note

Question 5

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

Accepted Answer

A potential participant who is evaluated but does not meet eligibility criteria

Answer

A participant who completes the study without adverse events

Answer

An IRB rejection of a protocol amendment

Answer

A failed data quality check

Question 6

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

Accepted Answer

The drug/device accountability log

Answer

The delegation of authority log

Answer

The IRB approval letter

Answer

The site feasibility questionnaire