Adverse Event Tracking
At every study visit, the subject should be observed for adverse events and should be asked about any adverse event that might have happened since the previous visit. Most of these adverse events might not meet the definition of an Unanticipated Problem Involving Risks to Subjects or Others. All study events need to be tracked meticulously in an Adverse Event Tracking Log. See HRPP Post-Approval Reporting for additional guidance.

Protocol Deviation Information
Although it is important to follow the protocol very strictly, deviations do sometimes occur due to various reasons. Some protocol deviations might meet the definition of an Unanticipated Problem Involving Risks to Subjects or Others. The Protocol Deviation Tracking Log tracks all the protocol deviations and serves as documentation of the determination of whether or not a particular deviation should be submitted to the IRB. See the HRPP Violation Incident Guidelines for additional guidance.

Note to File
A Note-to-File may be written by any member of the study team to provide additional information or clarification.

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