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 requirements and associated appendices can be found in the DAIDS SCORE Manual.
DAIDS requires sites to develop and implement a CQMP in order to meet Sponsor Regulatory requirements for oversight of Quality Management (QM) activities at its Clinical Research Sites (CRSs). This requires sites to submit a CQMP to DAIDS and also use a standardized format (CRS QA Summary Report) for data collection.
Sites must submit a draft CQMP to their OCSO Program Officer for review and approval during OSCO site activation and any time subsequent non-administrative changes are made.
QA findings must be submitted to DAIDS bi-annually on approximately June 1st and December 1st of every year, unless otherwise communicated by the DAIDS PO. Note that at DAIDS discretion, QA reporting may be required more frequently based on site performance, higher enrollment, or other DAIDS indicators.
Yes, any new site which has been OCSO site activated and had protocol activity for at least 3 months must submit their bi-annual CRS QA Summary Report.
No. A site should not conduct QA review on all PIDs. QA review should be on a percentage of unique PIDs during a specified period of time. The defined subset or percent of the site’s sample size must be documented in the CQMP. Sites, at their discretion, can go above their stated sample size based on certain criteria.
Reviewer refers to whomever is verifying the accuracy of the information on the tools. The same person would be the signatory on the last page of the tools.
The “person preparing report” is whomever is completing the report (the author). The individual may not always be the person submitting the report to DAIDS.
Total number of PIDS enrolled” includes all PIDs on study, regardless if they were reviewed at the time of completion of the report. Enrolled participants are those who are on study even if not seen during the 3-month reporting period and for whom you have performed a QA review.
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.
Yes
No. While sites may add site-specific KIs if applicable, the site must include all 11 DAIDS required KIs.
No, sites should report QA findings on only 20 PIDS however, they may, based on the percentage or sample sized described in their CQMP, conduct QA review on a larger number of PIDS as part of their established process.
If there are more than one (1) criteria for a KI, capture all associated criteria in the same row for that particular PID.
No. If a PID has two (2) KIs, the KIs should be listed in separate rows but will count as one PID towards the 20 PID maximum.
No. QA review at a site is a separate activity from site monitoring and reflects the site’s review of its own records. While PIDs with findings may overlap with some monitoring observations, we expect this overlap to be minimal.
We have added an additional template page for Section 4 that you can incorporate into your report. This is listed as an appendix on the SCORE Manual Quality Management section
A site will evaluate its CQMP after each QA review and/or when requested by DAIDS.
The QA review should cover at least 3 consecutive months of protocol activities at a site.
CQMPs must be signed and dated by the PI and/or CRS Leader and kept on file. Completed CRS QA Summary Reports, Chart Review and Regulatory File Review tools must be kept on file and available to DAIDS. Communication from OCSO Program Officer (PO) approving implementation of the site’s CQMP should be filed with the CQMP.
DAIDS may, at its discretion, ask for the tools used to populate the CRS QA Summary report, for example Chart Review and Regulatory File review tool. As Sponsor, DAIDS has a regulatory obligation to oversee Quality Management activities at its CRSs conducting DAIDS trials and sites must have these tools available.
Sites should file all QM related documents separately from the regulatory files, for example in a QM binder/QM folder/electronically. This would include the CQMP, Participant Chart Review Tools, Regulatory File Review Tools and CRS QA Summary Reports and any additional documents used in the QA reviews.
DAIDS will determine the best approach for reviewing QM activities at sites based on but not limited to:
- 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
The site’s PO will provide written feedback of their review within OCSO’s established timelines.