requirements for clinical quality management …...2019/10/17 · requirements for clinical quality...

Requirements for Clinical Quality Management Plans (CQMP) Policy

Bariatu Smith RN, MS, CCRAMJ Humphries RN, BS, CCRCIsabel 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 activitiesIncluding additional background on QM to reflect the expansion of

E6R2 in the ICH integrated addendumAdding 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 policyMust 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

of Understandingof 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

oNew Submission Date:December 13, 2019Subsequent submissions will be on June 1st and December 1st

oAdditional resources when completing the report:CQMP PolicyFAQsGuidance Document

DAIDS Clinical Research Policies and Standard Procedures Documents

- Site Implementation and Operations

- List of Frequently Asked Questions

CQMP Resources

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=2ahUKEwi6v_uoy6HlAhVDheAKHQ2vAMcQjRx6BAgBEAQ&url=%2Furl%3Fsa%3Di%26rct%3Dj%26q%3D%26esrc%3Ds%26source%3Dimages%26cd%3D%26ved%3D2ahUKEwjosf-Wy6HlAhXESt8KHewqBz8QjRx6BAgBEAQ%26url%3Dhttp%253A%252F%252Fclipart-library.com%252Fmagnifying-glass-cliparts.html%26psig%3DAOvVaw16aB3Fd7uRQu_nNw0CTG1l%26ust%3D1571343013210958&psig=AOvVaw16aB3Fd7uRQu_nNw0CTG1l&ust=1571343013210958

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

https://www.hanc.info/resources/Pages/DAIDS-docs.aspx

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 ToolRegulatory File Review ToolSite Monitoring ReportsDMC 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


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”


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/AAssessment of Understanding of ICF as applicable N/AEligibility Criteria and Process (as stated in the protocol) N/AProtocol Required Tests and Procedures


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



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”.


Key Indicator(s)


Protocol

XXXX

Protocol

YYYY

Protocol

_________

Protocol

_________

Protocol

_______


Visits/Missed Visits 0Concomitant Meds/Prohibited Meds.







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.


Key Indicator(s)


Protocol

XXXX

Protocol

YYYY

Protocol

_________

Protocol

_________

Protocol

_______


Visits/Missed Visits 2 0Concomitant Meds/Prohibited Meds.






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.


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)


Protocol

XXXX

Protocol

YYYY

Protocol

_________

Protocol

_________

Protocol

_______

Informed Consent Form (ICF) and Process(initial or subsequent) 2



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 PreventativeActions Implemented

123456 XXXX Informed Consent Form (ICF) andProcess (initial orsubsequent)

1. Informed consent process not documented in source

2. Participant was not offered copy of signed ICF

1. Note to File documented byappropriate site staff addedin 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.


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)


Protocol

XXXX

Protocol

YYYY

Protocol

_________

Protocol

_________

Protocol

_______

Informed Consent Form (ICF) and Process(initial or subsequent) 1

Visits/Missed Visits 1


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 PreventativeActions 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 on 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

ProtocolWas a Reg File reviewconducted?

If no review was done, provide anexplanation:

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.



Document findings

Criteria associated with

deficient documents



YYYY YES N/A DAIDS Approvals

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

2. Subsequent confirmation of submission not onfile.

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 documentfinding.

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



Document findings

Criteria associated with deficient documents



XXXX NO reg file review conducted during previous reviewperiod.

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 LeaderAt 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 oversightDAIDS will periodically review QM activities at CRSs to determine their

effectiveness and relevancy.

Ensure that the Summary Report is representative of your siteWe 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 [email protected] and Isabel Guerra at [email protected] questions prior to submitting the report.

If you have questions after the report has been submitted, please contact your OCSO PO.

mailto:[email protected]

mailto:[email protected]