What action should be taken regarding documentation when new information arises that may affect willingness to continue?

Boost your GCP E6 (R3) exam readiness. Improve your understanding with engaging, insightful questions. Test yourself with hints and detailed explanations. Prepare effectively!

Multiple Choice

What action should be taken regarding documentation when new information arises that may affect willingness to continue?

When new information arises that could affect a participant’s willingness to continue, you must inform the participant or their legally acceptable representative promptly. This preserves ongoing informed consent and the participant’s autonomy. The communication should be documented as a clear, traceable record of what information was shared, to whom, when, how it was delivered, and the participant’s response, including any questions and the decision about continuing. Simply documenting the information or informing only the sponsor does not respect the participant’s right to be informed, and withholding information from the participant is not appropriate.

When new information arises that could affect a participant’s willingness to continue, you must inform the participant or their legally acceptable representative promptly. This preserves ongoing informed consent and the participant’s autonomy. The communication should be documented as a clear, traceable record of what information was shared, to whom, when, how it was delivered, and the participant’s response, including any questions and the decision about continuing. Simply documenting the information or informing only the sponsor does not respect the participant’s right to be informed, and withholding information from the participant is not appropriate.

More practice questions