Requirements for Clinical Quality Management Plans (CQMP) Policy Policy POL-A28-OCS-001.00, Effective July 5, 2019 Bariatu Smith RN, MS, CCRA MJ Humphries RN, BS, CCRC Isabel Guerra, MPH
Objectives To highlight the changes in the updated required DAIDS CQMP Policy To provide highlights on the requirements of a site CQMP To provide instructions on the completion of the CRS QA Summary Report template
Revised Policy – Effective July 5, 2019 Meets sponsor regulatory requirements for oversight of Quality Management (QM) activities at Clinical Research Sites (CRSs ).
So what has changed? 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 Adding a new Key Indicator (KI) Revising the CRS QA Summary Report Template
CQMP Update Requirements Sites must submit a new CQMP to be in compliance with the new policy Must be submitted with the first CRS QA Summary Report on December 13 th , 2019. Ensure that the CQMP includes the required elements
CQMP Elements Roles and Responsibilities Key Indicators for QA/QC review Description of QM activities Description of QM Tools QA Audit Sample Size Description of QA activities for protocol regulatory files Documentation of QM activities Evaluation Process Reporting Retention of QM documents
Informed Consent Form (ICF) and Process Assessment Investigator of Understanding File Review of ICF as Deficiencies applicable Source Eligibility Documents, Criteria and Signatures, Process Initials, Dates DAIDS CQMP Key Protocol Defined Protocol Endpoint Required Indicators Identification Tests and and reporting Procedures as applicable AE, SAE, and DAIDS EAE, Visits/Missed identification Visits and reporting Study Product Concomitant/ Administration Prohibited /Dosing Medications
Review Tools
Completing the CRS QA Summary Report o New Submission Date: December 13, 2019 Subsequent submissions will be on June 1 st and December 1 st o Additional resources when completing the report: CQMP Policy FAQs Guidance Document
CQMP Resources DAIDS Clinical Research Policies and Standard Procedures Documents - Site Implementation and Operations - List of Frequently Asked Questions
Site Guidance Document A guidance document with instructions and examples to aid in the completion of the CRS QA Summary Report has been posted on the HANC website. Resources DAIDS Resources and Announcements Guidelines and Documents
Report Cover Page
1. Summary of Protocols Reviewed • Complete only for protocols associated with PIDs for which chart review was conducted during this review period. • Please report no more than five (5) protocols • Please rotate protocols with each submission • At DAIDS discretion, certain protocols can be requested for inclusion in submission of QA Summary reports
2. List tools used for this QA Review Participant Chart Review Tool Regulatory File Review Tool Site Monitoring Reports DMC query reports
3. Summary of Key Indicators (KIs) and Number of Associated Findings Sites are required to report numbers for all 11 KIs defined in the Policy. o Sites may add additional KIs to this section, but may not omit any of the required KIs. Only populate the protocol numbers that you are reporting in the table in Section 1, “Summary of Protocols Reviewed.” Please report all KIs for all participants reviewed from the five (5) protocols you are reporting.
3. Summary of Key Indicators (KIs) and Number of Associated Findings
3. Summary of Key Indicators (KIs) and Number of Associated Findings If a KI is not applicable to a protocol or the time-period of review, report “N/A” for that KI. For example, for Protocol YYYY, if all participants have already been enrolled and the study is in the follow-up phase, then the KIs Informed Consent Form (ICF) and Process , Assessment of Understanding of ICF , and Eligibility Criteria and Process should be marked as “N/A”
3. Summary of Key Indicators (KIs) and Number of Associated Findings Number of Findings (per protocol) Key Indicator(s) Protocol Protocol Protocol Protocol Protocol XXXX YYYY _________ _________ _______ Informed Consent Form (ICF) and Process N/A (initial or subsequent) N/A Assessment of Understanding of ICF as applicable Eligibility Criteria and Process N/A (as stated in the protocol) Protocol Required Tests and Procedures Visits/Missed Visits Concomitant Meds/Prohibited Meds. Study Product Administration/Dosing AEs/SAEs/EAEs identification and reporting Protocol Defined Endpoint identification and reporting as applicable Source Docs, Signatures, Initials and Dates Investigator File Review Deficiencies
3. Summary of Key Indicators (KIs) and Number of Associated Findings If there are no findings for a certain KI for a given protocol, report “0” for that KI. For example, in Protocol YYYY, if all visits were conducted within the visit window during the review period, then the KI Visits/Missed Visits should be reported as “0”.
3. Summary of Key Indicators (KIs) and Number of Associated Findings Number of Findings (per protocol) Key Indicator(s) Protocol Protocol Protocol Protocol Protocol XXXX YYYY _________ _________ _______ Informed Consent Form (ICF) and Process N/A (initial or subsequent) N/A Assessment of Understanding of ICF as applicable Eligibility Criteria and Process N/A (as stated in the protocol) Protocol Required Tests and Procedures 0 Visits/Missed Visits Concomitant Meds/Prohibited Meds. Study Product Administration/Dosing AEs/SAEs/EAEs identification and reporting Protocol Defined Endpoint identification and reporting as applicable Source Docs, Signatures, Initials and Dates Investigator File Review Deficiencies
3. Summary of Key Indicators (KIs) and Number of Associated Findings If there is more than one (1) finding for a given KI, then the number of findings reported for that KI will be the actual number of findings. For example, for Protocol XXXX, if you have a participant that missed one (1) visit, and one (1) out of window visit, then you will report two (2) under Visit/Missed Visits KI .
3. Summary of Key Indicators (KIs) and Number of Associated Findings Number of Findings (per protocol) Key Indicator(s) Protocol Protocol Protocol Protocol Protocol XXXX YYYY _________ _________ _______ Informed Consent Form (ICF) and Process N/A (initial or subsequent) N/A Assessment of Understanding of ICF as applicable Eligibility Criteria and Process N/A (as stated in the protocol) Protocol Required Tests and Procedures 2 0 Visits/Missed Visits Concomitant Meds/Prohibited Meds. Study Product Administration/Dosing AEs/SAEs/EAEs identification and reporting Protocol Defined Endpoint identification and reporting as applicable Source Docs, Signatures, Initials and Dates Investigator File Review Deficiencies
4. Summary of Deficient Key Indicators (KIs) and associated Criteria Enter no more than 20 PID entries in this section. These PIDs should be associated with the five (5) protocols that you have chosen to report in the previous section When choosing which PIDs to report, focus on choosing as many different identified deficient KIs as possible.
4. Summary of Deficient Key Indicators (KIs) and associated Criteria
4. Summary of Deficient Key Indicators (KIs) and associated Criteria In the example below, there is a PID with one (1) KI deficiency for protocol XXXX but two (2) findings for the KI deficiency, so you will report two (2) findings . Number of Findings (per protocol) Key Indicator(s) Protocol Protocol Protocol Protocol Protocol XXXX YYYY _________ _________ _______ Informed Consent Form (ICF) and Process 2 (initial or subsequent) Visits/Missed Visits
4. Summary of Deficient Key Indicators (KIs) and associated Criteria Examples shows one (1) KI with two (2) associated criteria PID # Protocol Deficient Key Criteria Describe Corrective Describe Preventative (list only 1 # Indicator(s) Associated with Actions Implemented Actions Implemented PID per Deficient KIs line) 1. Note to File documented by 123456 XXXX 1. Informed consent Informed Consent Revise informed consent (IC) appropriate site staff added Form (ICF) and process not checklist to include review of IC in chart Process documented in requirements including proper (initial or source subsequent) documentation prior to participant departure from clinic. 2. Participant was not 2. Participant was called, *This preventative action plan offered copy of signed asked to return to clinic, and offered a copy applies to both criteria ICF associated with the deficient KI. The CAPA required 2 different corrective actions but the preventative action was applicable to both findings.
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