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What and When to Report on this Formal problems, protocol and regulatory deviations, protocol and regulatory violations and adverse events occurring on a study overseen by the Southwest Tribal IRB
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How to fill out protocol deviations and adverse

01
Clearly document any deviation from the study protocol in the designated section of the case report form.
02
Provide a detailed explanation for the deviation, including the reason it occurred and any corrective actions taken.
03
Ensure all deviations are reviewed and approved by the study investigator before being submitted to the sponsor or regulatory authorities.
04
For adverse events, follow the specific reporting guidelines outlined in the study protocol and regulatory requirements.
05
Include all relevant information about the adverse event, including the date of onset, severity, outcome, and any actions taken in response.

Who needs protocol deviations and adverse?

01
Researchers conducting clinical trials
02
Study coordinators and clinical research associates
03
Regulatory bodies overseeing the study
04
Sponsors funding the study

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Protocol deviations refer to any departure from the study protocol that may affect the integrity of the study, while adverse events are any undesirable experiences associated with the use of a medical product or intervention.
Researchers, clinical trial sponsors, and institutions conducting clinical trials are required to file protocol deviations and adverse events.
To fill out protocol deviations and adverse events, one should provide detailed descriptions of the event, the date it occurred, actions taken, and the impact on the study.
The purpose is to ensure patient safety, maintain the validity of the study, and comply with regulatory requirements.
Information to be reported includes a description of the event, date, severity, actions taken, resolution status, and any relevant patient details.
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