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DENEBOLA ETHICS COMMITTEE2 INITIAL EXPEDITED REVIEWSYEC2/SOP7B/v1 14/06/2018Page 1 of 20YENEPOYA ETHICS COMMITTEE2 INITIAL EXPEDITED REVIEWSYEC2/SOP7B/v1 14/06/2018Table of Contents: No. Contents
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Fill in the necessary details such as study name, protocol number, date of deviation, nature of deviation, reason for not reporting earlier, and actions taken to prevent recurrence.
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Researchers involved in clinical trials or scientific studies.
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Compliance officers responsible for ensuring protocol adherence.
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Quality assurance personnel monitoring study conduct.
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Unreported protocol deviationsform tip is a form that is used to report any deviations from the protocol that were not previously disclosed.
The principal investigator or study sponsor is required to file unreported protocol deviationsform tip.
To fill out unreported protocol deviationsform tip, one must provide details of the deviation, impact on the study, and any corrective actions taken.
The purpose of unreported protocol deviationsform tip is to ensure transparency and accuracy in clinical trial reporting.
The information that must be reported on unreported protocol deviationsform tip includes the nature of the deviation, when it occurred, and its impact on the study.
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