RA Industry Best Practices 4

Question 1

Which version of the informed consent form must be used when consenting a new participant?

Accepted Answer

The current IRB-approved version

Answer

Using an outdated or unapproved consent version is a significant protocol and regulatory deviation.

Question 2

A participant cannot read but wants to join a trial. According to ICH E6, what is required during the consent process?

Accepted Answer

An impartial witness is present for the entire consent discussion

Answer

An impartial witness attends the whole discussion and signs to confirm the information was explained and consent was freely given.

Question 3

Under 21 CFR 312.64, when must an investigator report a serious adverse event to the sponsor?

Accepted Answer

Immediately

Answer

Investigators must report serious adverse events to the sponsor immediately, whether or not they think the event is drug-related.

Question 4

In a blinded trial, when may site staff break the blind for one participant?

Accepted Answer

In a medical emergency, following the protocol's unblinding procedure

Answer

Emergency unblinding follows protocol-defined procedures and is documented and reported to the sponsor.

Question 5

What is the main goal of the root cause analysis step in a CAPA plan?

Accepted Answer

To find the underlying reason for a problem so the corrective action stops it from happening again

Answer

Effective CAPA targets the systemic cause rather than the symptom.

RA - Certified Research Assistant Practice Test