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How soon should deviations from the protocol be reported if they occur without IRB approval?

Within 24 hours

As soon as possible

The correct response emphasizes the importance of timely communication regarding protocol deviations in clinical research. When a deviation occurs without Institutional Review Board (IRB) approval, it is crucial to report it as soon as possible to ensure patient safety and adherence to ethical standards.

Immediate reporting is important for several reasons:

1. **Participant Safety**: Protocol deviations can impact the safety or efficacy of a trial, and prompt communication allows for rapid assessment of any potential risks to participants.

2. **Regulatory Compliance**: Keeping regulatory bodies informed ensures adherence to GCP (Good Clinical Practice) guidelines and institutional policies, which can crucially affect the validity of the study and the trustworthiness of the data collected.

3. **Corrective Actions**: Early identification of deviations allows for timely corrective actions, which might be necessary to mitigate any adverse effects or to return the study to its approved protocol.

This approach underlines the ethical responsibility of researchers to maintain transparent communication regarding the conduct of the study, thus fostering trust and accountability within the research process.

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After the study is completed

Only if requested by the sponsor

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