Summary

A CRA, trainer or member of the QA team may want to be able to review activities that any given member of staff performed on a specific study, in order to:

• Check that they were trained in the activities

• Ensure they did not perform these activities before they were formally delegated to do so by the PI

• See the period of involvement of the staff in the study

Report Output

Excel Document with the following tabs:

• Subject Audits

• Study Event Audits

• Form AuditsForm Annotations

• Item Group Audits

• Item Group Annotations

• Item Audits

• Item Annotations

• Review AuditsAudits

• Lab Review Audits

• Lab Order Details

• Lab Panel Results

• Lab Test Results

• Sample Processing Audits

• Sample Processing Annotation Audits

• Medical Coding

• ECG Review

Report Logic

Report all audits present in the Study Data module at each level of data hierarchy, with one audit record reported per row within its respective sheet.

Example Report

Report Walkthrough

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