Industry Best Practices Flashcards

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

Answer: The current IRB-approved version

Using an outdated or unapproved consent version is a significant protocol and regulatory deviation.

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

Answer: An impartial witness is present for the entire consent discussion

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

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

Answer: Immediately

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

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

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

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

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

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

Effective CAPA targets the systemic cause rather than the symptom.

How should a research assistant best prepare for a sponsor monitoring visit?

Answer: Have source documents, the regulatory binder, and up-to-date CRFs ready for review

Monitors verify CRF data against source and check regulatory files, so complete, accessible records make the visit efficient.

Which statement about using a note-to-file (NTF) is considered best practice?

Answer: NTFs should explain a specific issue, be signed and dated, and not be used in place of corrective action

Regulators warn against overusing NTFs; they record an explanation but do not correct systemic problems.