Requirements for Clinical Quality Management Plans (CQMP) Policy - - PowerPoint PPT Presentation

Requirements for Clinical Quality Management Plans (CQMP) Policy

Bariatu Smith RN, MS, CCRA MJ Humphries RN, BS, CCRC Isabel Guerra, MPH

Policy POL-A28-OCS-001.00, Effective July 5, 2019

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 13th, 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

DAIDS CQMP Key Indicators

Informed Consent Form (ICF) and Process Assessment

• f Understanding
• f ICF as

applicable Eligibility Criteria and Process Protocol Required Tests and Procedures Visits/Missed Visits Concomitant/ Prohibited Medications Study Product Administration /Dosing AE, SAE, and DAIDS EAE, identification and reporting Protocol Defined Endpoint Identification and reporting as applicable Source Documents, Signatures, Initials, Dates Investigator File Review Deficiencies

Review Tools

Completing the CRS QA Summary Report

• New Submission Date:
• December 13, 2019
• Subsequent submissions will be on June 1st and December 1st
• Additional resources when completing the report:
• CQMP Policy
• FAQs
• Guidance Document

DAIDS Clinical Research Policies and Standard Procedures Documents

• Site Implementation and

Operations

• List of Frequently Asked

Questions

CQMP Resources

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.
• 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

• f ICF, and Eligibility Criteria and Process should be marked as

“N/A”

• 3. Summary of Key Indicators (KIs) and Number of

Associated Findings

Key Indicator(s) Number of Findings (per protocol) Protocol XXXX Protocol YYYY Protocol _________ Protocol _________ Protocol _______ Informed Consent Form (ICF) and Process (initial or subsequent)

N/A

Assessment of Understanding of ICF as applicable

N/A

Eligibility Criteria and Process (as stated in the protocol)

N/A

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

Key Indicator(s) Number of Findings (per protocol) Protocol XXXX Protocol YYYY Protocol _________ Protocol _________ Protocol _______ Informed Consent Form (ICF) and Process (initial or subsequent)

N/A

Assessment of Understanding of ICF as applicable

N/A

Eligibility Criteria and Process (as stated in the protocol)

N/A

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 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
• ne (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

Key Indicator(s) Number of Findings (per protocol) Protocol XXXX Protocol YYYY Protocol _________ Protocol _________ Protocol _______ Informed Consent Form (ICF) and Process (initial or subsequent)

N/A

Assessment of Understanding of ICF as applicable

N/A

Eligibility Criteria and Process (as stated in the protocol)

N/A

Protocol Required Tests and Procedures Visits/Missed Visits

2

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.

Key Indicator(s) Number of Findings (per protocol) Protocol XXXX Protocol YYYY Protocol _________ Protocol _________ Protocol _______ Informed Consent Form (ICF) and Process (initial or subsequent) 2 Visits/Missed Visits

• 4. Summary of Deficient Key Indicators (KIs) and

associated Criteria

Examples shows one (1) KI with two (2) associated criteria The CAPA required 2 different corrective actions but the preventative action was applicable to both findings.

PID #

(list only 1 PID per line)

Protocol # Deficient Key Indicator(s) Criteria Associated with Deficient KIs Describe Corrective Actions Implemented Describe Preventative Actions Implemented 123456 XXXX Informed Consent Form (ICF) and Process (initial or subsequent)

• 1. Informed consent

process not documented in source

• 2. Participant was not
• ffered copy of signed

ICF

• 1. Note to File documented by

appropriate site staff added in chart

• 2. Participant was called,

asked to return to clinic, and offered a copy Revise informed consent (IC) checklist to include review of IC requirements including proper documentation prior to participant departure from clinic. *This preventative action plan applies to both criteria associated with the deficient KI.

• 4. Summary of Deficient Key Indicators (KIs) and

associated Criteria

• In protocol YYYY below, there is a PID with one KI deficiency for

“Informed Consent Form (ICF) and Process” and one KI deficiency for “Visits/Missed Visits,” so you will report each deficiency separately.

Key Indicator(s) Number of Findings (per protocol) Protocol XXXX Protocol YYYY Protocol _________ Protocol _________ Protocol _______

Informed Consent Form (ICF) and Process (initial or subsequent)

1

Visits/Missed Visits

1

• 4. Summary of Deficient Key Indicators (KIs) and

associated Criteria

Examples shows PID with more than one (1) deficient KI; each KI is listed in separate rows Even though PID is listed twice, it still counts as one (1) PID towards the 20 PID Requirement.

PID #

(list only 1 PID per line)

Protocol # Deficient Key Indicator(s) Criteria Associated with Deficient KIs Describe Corrective Actions Implemented Describe Preventative Actions Implemented 78910 YYYY Visits/Missed Visits Participant missed visit 15/Month 4. Note to File documented by appropriate site staff added in chart. Participants will be called to remind them of their study visits 3 days before the visit day. 78910 YYYY Informed Consent and Process Participant was provided the wrong version of the ICF. Participant was asked to return to clinic and sign the correct version. Site will add a QC step of ensuring correct version of ICF

• n the ICF checklist

• 5. Regulatory File Review
• Use the CQMP Protocol Regulatory File Review Tool
• Populate the table with the findings from your QA review for the same

protocols that you’ve listed in Section 1 and 3.

• 5. Regulatory File Review

• 5. Regulatory File Review
• In the example below, Protocol YYYY has one category of document finding,

“DAIDS Approvals” with two (2) criteria for that category of document, so you will report 2 findings.

Since both criteria are associated to the same category of document, they are listed in the same row

Protocol Was a Reg File review conducted? If no review was done, provide an explanation: Document findings Criteria associated with deficient documents Describe corrective actions implemented Describe preventative actions implemented

YYYY

YES

N/A

DAIDS Approvals 1. Initial DAIDS Protocol Registration Office (DAIDS PRO) notification not on file. 2. Subsequent confirmation of submission not on file Locate DAIDS PRO approval letters and file in regulatory binder. Implement a filing system for all documents on a weekly basis. Delegate task to research assistant *This preventative action plan applies to both criteria associated with the document finding

• 5. Regulatory File Review
• Protocol YYYY has a second category of document finding, “CVs,

Biographical Sketches, Licenses.” You will report it in a separate row.

Since there are different categories of document findings, they are listed in separate rows, listing the protocol number twice. Protocol Was a Reg File review conducted? If no review was done, provide an explanation: Document findings Criteria associated with deficient documents Describe corrective actions implemented Describe preventative actions implemented YYYY YES N/A DAIDS Approvals

1.

Initial DAIDS Protocol Registration Office (DAIDS PRO) notification not on file .

2.

Subsequent confirmation of submission not on file. Locate DAIDS PRO approval letters and file in regulatory binder. Implement a filing system for all documents on a weekly basis. Delegate task to research assistant *This preventative action plan applies to both criteria associated with the document finding. YYYY YES N/A Sketches; CVs; Biographical Licenses CV for new staff member was not on file Request new staff to sign and date CV to file in the binder Implement process for new staff joining clinic and the required documentation that must be submitted to the regulatory officer

• 5. Regulatory File Review
• There was no regulatory review performed for Protocol XXXX for this

reporting period, so you will report “N/A” as indicated below.

Provide a reason for not doing regulatory review here

Protocol Was a Reg File review conducted? If no review was done, provide an explanation: Document findings Criteria associated with deficient documents Describe corrective actions implemented Describe preventative actions implemented XXXX NO reg file review conducted during previous review period. N/A N/A N/A N/A

• 6. CQMP Revision
• Per the DAIDS CQMP Policy, the CRS will evaluate the CQMP after

each QA review.

For example:

• Re-review of eligibility criteria before

enrollment

• Orientation to regulatory file requirements

for all new staff involved with protocol implementation

Reporting to DAIDS

• QA findings will be reported to DAIDS bi-annually using the CRS QA

Summary Report template.

• Submit your report to your OCSO PO and copy your CRS Leader
• At DAIDS discretion, QA reporting may be required more frequently

based on site performance, higher enrollment etc.

• DAIDS will review the CRS QA Summary Report using a DAIDS defined

process and communicate any recommendations and/or requests for additional information to the CRS.

Document Retention

• The CQMP will be signed and dated by the PI

and/or the CRS Leader and kept on file separate from the Regulatory File.

• Completed CRS QA Summary Reports, Chart

Review Tools, Protocol Regulatory File Review Tools and any other site tools used to conduct QA reviews will be kept on file and accessible upon DAIDS request.

Take away message…

• DAIDS has implemented a more robust process for oversight
• DAIDS will periodically review QM activities at CRSs to determine their

effectiveness and relevancy.

• Ensure that the Summary Report is representative of your site
• We expect that you’ll choose PIDs that represent issues/findings

based on your QM processes

• CQMP is not just a document to draft and file away

MULTIPLE PARTS REQUIRE COORDINATED EFFORTS

Ultimately this is about the safety of the participants and the quality of the data

Questions

Please contact both MJ Humphries at humphriesmj@niaid.nih.gov and Isabel Guerra at Isabel.Guerra@nih.gov for questions prior to submitting the report. If you have questions after the report has been submitted, please contact your OCSO PO.