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1. Source data/documentation should be:

A) Attributable, legible, correct, original, accurate, and complete.
B) Attributable, legible, correct, original, accurate, and clear.
C) Attributable, legible, contemporaneous, original, accurate, and clear.
D) Attributable, legible, contemporaneous, original, accurate, and complete.

2. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 6 participants
B) 5 participants
C) 4 participants
D) 3 participants

3. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Approval of protocol by the PI.
D) Submission of documents to IRB/IEC and regulatory authority for review.

4. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A member of the research team
B) A family member
C) A witness
D) A legally acceptable representative

5. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Withdraw the subject.
B) Notify the subject.
C) Notify the regulatory authority.
D) Notify the sponsor.

問題與答案：