This section provides answers to the frequently asked questions (FAQs) regarding the Division of AIDS (DAIDS) Clinical Quality Management Plan (CQMP) Policy.
1. Where can sites find the current Clinical Quality Management Plan (CQMP) Policy and the fillable PDF Clinical Research Site (CRS) Quality Assurance (QA) Summary Report?
The policy and associated appendices can be found on DAIDS Clinical Research Policies.
2. Why did DAIDS revise the policy?
The policy was revised to meet Sponsor Regulatory requirements for oversight of Quality Management (QM) activities at its CRSs. In order to accomplish this DAIDS must document how oversight is provided for QM. This requires a standardized format (CRS QA Summary Report) for data collection from sites.
3.What are the major changes to the policy?
The major changes include:
- Strengthening sponsor oversight with the following:
- Defining Program Officer (PO) responsibilities
- Adding DAIDS review of QM activities
- Including additional background on QM to reflect the expansion of E6R2 in the ICH integrated addendum.
- Addition of a new Key Indicator (KI)
- A major revision of the CRS QA Summary Report template
4. What are the revisions to the Key Indicators (KIs)?
- “Investigator File Review deficiencies” has been added as a new KI.
- The KI “Eligibility Criteria” now includes “and Process,” which can refer to a site SOP or checklist or any other process used to verify participant eligibility.
5. Do sites have to revise their CQMP based on the new DAIDS CQMP Policy?
Yes, sites will need to revise their CQMP to be in compliance with the new DAIDS CQMP Policy. This includes the additional key indicator (KI), “Investigator File Review Deficiencies,” as well as updating the “Eligibility Criteria” KI to include “and process.” Additionally, for any subsequent versioned changes to the site’s CQMP, sites must submit a signed copy to their OCSO Program Officer.
6. Are new sites required to submit a CRS QA Summary Report?
7. How often do I need to submit a CRS QA Summary Report to DAIDS?
QA findings must be submitted to DAIDS bi-annually. The first submission will be due 01 December 2019 and it will become due on 01 June and 01 December at subsequent years. Note that at DAIDS discretion, QA reporting may be required more frequently based on site performance, higher enrollment, or other DAIDS indicators.
8. Can sites continue to use their old CRS QA Summary Report forms?
No, starting with the next submission of the CRS QA Summary Report, sites must use the revised form.
9. Should a site conduct QA review on all Participant IDs (PIDs) seen during the review period?
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 can go above their stated sample size based on certain criteria, as necessary.
10. What does “Reviewer” mean on the Chart and Regulatory File Review tools?
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.
11. What does “person preparing report” on the QA Summary Report mean?
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.
12. In the CRS QA Summary Report, what is meant by “total number of PIDS enrolled?”
“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.
13. What does it mean to rotate protocols for QA review?
The QA Summary Report requires that you report QA findings on 5 protocols or fewer for each submission.
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, on a 3-month review period, 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.
14. Should PIDs with findings correspond to protocols reported on the CRS QA Summary Report?
15. Can the site use its own list of Key Indicators?
While sites may add site-specific KIs if applicable, the site still needs to include all DAIDS KIs listed in the current CQMP policy.
16. Can sites submit QA findings on more than 20 PIDS?
No, sites should report QA findings on only 20 PIDS. Sites should however, continue to follow their established process and conduct QA review on the stated percentage or sample size as documented in their CQMP. The addendum for E6R2 emphasizes Quality by Design (QBD) and Quality Risk Management (QRM). The revised CQMP policy and the CRS QA Summary Report are reflective of a QRM process.
17. What if there is a PID with one (1) KI but two (2) different criteria for that KI?
If there are more than one (1) criteria for a KI, capture all associated criteria in the same row for that particular PID.
18. Can a PID with more than one KI be counted more than once?
If a PID has two (2) KIs, please list the KIs in separate rows. This would still count as one PID towards the 20 PID limit.
19. Can I use findings from my site monitoring report as findings in my CRS QA Summary Report?
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.
20. What should I do, if I need additional pages to Section 4 of the CRS QA Summary Report?
21. How often should a site evaluate their CQMP?
A site will evaluate its CQMP after each QA review.
22. What is the minimum period for a QA review?
The QA review should cover at least 3 consecutive months of protocol activities at a site.
23. Do I need to file my CQMP?
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 DAIDS Program Officer (PO) recommending implementation of the site’s CQMP should be filed with the CQMP.
24. Why does DAIDS want sites to file the tools used to capture data that is submitted on the CRS QA Summary report kept on file at the site 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.
25. Where should I file my QM documents??
Sites should file all QM related documents separately from the regulatory files, for example 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 performed.
26. How will DAIDS review QM activities at my site?
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 and communication with internal and external stakeholders.
27. What should a site expect after the CRS QA Summary report has been submitted to their PO?
The site’s PO will provide written feedback of their review within 30 calendar days.