These FAQs are related to the requirements for the Clinical Quality Management Plan (CQMP) and QA Summary Report as outlined in the DAIDS Site Clinical Operations and Research Essentials (SCORE) manual in the section on Quality Management. Please contact your OCSO PO with any additional questions.
The QA Summary Report requires that you report QA findings on 5 protocols.
If your QA Review includes more than 5 protocols, please include only 5 of those protocols on the CRS QA Summary Report. At the next submission of the QA Summary Report, please include protocols not previously reported (i.e. rotate the protocols). You should do this for each submission.
If you are conducting fewer than 5 protocols during your 3-month review period, submit findings on the number of protocols you are conducting. If at the next review and reporting period, you are conducting only the same protocols previously reported, please continue to report on those same protocols.
- Review of the QM Summary reports
- Information in Site Monitoring Reports (SMRs)
- Processes within DAIDS Quality Management System
- Other types of reports
- Communication with internal and external stakeholders