CRC Foundations - Principal
Investigator (PI) Responsibilities
questions with answers.
Which of the following is true regarding FDA inspections?
A) The sponsor or study subjects may contact the FDA to report concerns, which may result in an audit
of the PI's site.
B) The sponsor may choose which sites the FDA audits.
C) The PI does not need to be present for the FDA audit as long as the research staff are available.
D) The PI may refuse to allow access to study essential documents if the FDA decides to complete a for-
cause audit. ANS -The sponsor or study subjects may contact the FDA to report concerns, which may
result in an audit of the PI's site.
*For-cause audits may be conducted if, during the monitoring process, the sponsor has documented
accounts of possible noncompliance, data discrepancies, or concerns regarding ethical conduct of the
study. The sponsor may contact the FDA and report the concerns. Study subjects also may contact the
FDA (21 CFR 50).
In order to document the delegation of study-related tasks, the PI should:
A) Ask the research nurse to sign the delegation log on the PI's behalf.
B) Use the same delegation log for each study in order to be consistent.
C) Keep a signed and dated delegation log that describes the delegated tasks, identifies that study staff
have received training that qualifies them to perform the tasks, and documents dates of involvement in
the study.
D) Not worry if the study plan does not allow certain study staff to perform tasks. ANS -Keep a signed
and dated delegation log that describes the delegated tasks, identifies that study staff have received
training that qualifies them to perform the tasks, and documents dates of involvement in the study.
Investigator (PI) Responsibilities
questions with answers.
Which of the following is true regarding FDA inspections?
A) The sponsor or study subjects may contact the FDA to report concerns, which may result in an audit
of the PI's site.
B) The sponsor may choose which sites the FDA audits.
C) The PI does not need to be present for the FDA audit as long as the research staff are available.
D) The PI may refuse to allow access to study essential documents if the FDA decides to complete a for-
cause audit. ANS -The sponsor or study subjects may contact the FDA to report concerns, which may
result in an audit of the PI's site.
*For-cause audits may be conducted if, during the monitoring process, the sponsor has documented
accounts of possible noncompliance, data discrepancies, or concerns regarding ethical conduct of the
study. The sponsor may contact the FDA and report the concerns. Study subjects also may contact the
FDA (21 CFR 50).
In order to document the delegation of study-related tasks, the PI should:
A) Ask the research nurse to sign the delegation log on the PI's behalf.
B) Use the same delegation log for each study in order to be consistent.
C) Keep a signed and dated delegation log that describes the delegated tasks, identifies that study staff
have received training that qualifies them to perform the tasks, and documents dates of involvement in
the study.
D) Not worry if the study plan does not allow certain study staff to perform tasks. ANS -Keep a signed
and dated delegation log that describes the delegated tasks, identifies that study staff have received
training that qualifies them to perform the tasks, and documents dates of involvement in the study.
