Get University Hospitals Internal Qa Checklist - Participant 2018

This guide provides clear and detailed instructions for filling out the University Hospitals Internal QA Checklist - Participant online. By following these steps, users can ensure that all required information is accurately documented.

Follow the steps to complete the Internal QA Checklist effectively.

1. Click the ‘Get Form’ button to obtain the Internal QA Checklist and open it for further editing.
2. Begin filling out the subject ID field, ensuring that you include the subject ID associated with the participant. In the initials/date section, record your initials and the current date.
3. Under the informed consent document/HIPAA authorization section, check that all required signatures are present. This includes the participant's signature and date, as well as signatures from any parent or legal guardian, and the person obtaining consent. Mark the appropriate box for each item as ‘Yes’, ‘No’, or ‘N/A’.
4. Document any comments related to informed consent, noting if all originals are available and properly executed without any missing content or incomplete fields.
5. Ensure all participant safety reporting requirements are satisfied by verifying that relevant study-related information such as adverse events, protocol deviations, and significant events have been reported. Mark the compliance box accordingly.
6. In the test article/device accountability section, verify that all investigational products and devices were utilized per protocol. Document all administrated products along with their start and stop times, and ensure that a subject-specific accountability log is maintained.
7. Proceed to the specimens section, confirming that all specimen collection aligns with protocol requirements. Ensure that abnormal specimen results have been evaluated and documented appropriately.
8. In the data collection and source documentation section, verify that all visits occur within the specified windows, noting any missed visits on the protocol deviation log. Ensure that study-specific procedures are signed off by qualified personnel.
9. As you complete each verification point related to study data, ensure to mark each applicable box as ‘Yes’, ‘No’, or ‘N/A’. Refer to protocol documentation for inclusion and exclusion criteria, ensuring that corrections, if any, are appropriately noted.
10. Finalize the form by reviewing the financial information section. Confirm that all study-related expenses and participant compensations have been accurately recorded and reconciled.
11. After completing the checklist, save any changes, and download, print, or share the document as required for your records.

Complete your documentation online today to ensure compliance and proper record-keeping.