Rescue acrin 4701 protocol development regulatory compliance pdrc
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RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC). Josephine Schloesser, ACRIN Monitor Chris Steward, ACRIN QC Auditor. PDRC. Overview: Regulatory Requirements Adverse Events Monitoring Program Auditing Program Image Review Follow-up Resources. Monitoring Process.

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RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC)

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Rescue acrin 4701 protocol development regulatory compliance pdrc

RESCUE: ACRIN 4701Protocol Development & Regulatory Compliance (PDRC)

Josephine Schloesser, ACRIN Monitor

Chris Steward, ACRIN QC Auditor


Rescue acrin 4701 protocol development regulatory compliance pdrc

PDRC

Overview:

  • Regulatory Requirements

  • Adverse Events

  • Monitoring Program

  • Auditing Program

  • Image Review

  • Follow-up

  • Resources


Monitoring process

Monitoring Process

Monitoring process ensures the following:

  • The rights, safety and well-being of the human subjects are protected.

  • The reported trial data are accurate, complete and verifiable from source documents.

  • The conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP and with applicable regulatory requirements.


Regulatory requirements

Regulatory Requirements

  • Sites must have initial IRB approval for the protocol and site-specific informed consent form on file at ACRIN Headquarters prior to site activation.

  • International sites may use an Ethics Committee instead of an IRB

  • Other regulatory documents are may be required as the trial progresses, i.e. IRB annual IRB approval, amendment approvals

  • All documents faxed to ACRIN PDRC at 215 717-0936


Regulatory documents

IRB Approvals For

Protocol, ICF & Amendments

Annual reviews

Revised ICFs

Recruitment & retention materials

Participant questionnaires

Others as necessary

Site Signature and Responsibilities Log

Approved Medical Authorization Release Form

ACRIN Statement of Investigator

Regulatory Documents


Monitoring program

Monitoring Program

  • Remote/off-site review by ACRIN Monitor(s)

  • Monitoring begins at the time of site qualification with review of site-specific regulatory documents and continues throughout the conduct of the trial

  • Frequency and timing depends on the rate of enrollment, site performance and protocol status

  • Review

    • Regulatory Documents / IRB Binder

    • Study-specific Processes

    • Participant Cases

    • Imaging Processes (with Image Management Center)

    • Adverse Events


Adverse events

Adverse Events

  • Monitoring for AEs is imperative

  • Proper documentation of protocol-specific AEs is mandatory

  • Assignment of grade and attribution is made by the Site Principal Investigator

  • Prompt reporting of AEs is the responsibility of the investigator and/or investigator-designee


Adverse events1

Adverse Events

  • For trial purposes, only AEs considered possibly, probably or definitely related to study-related cardiac CTA will be collected; they must be managed, documented, and reported per protocol section 10.0

  • AEs pertaining to standard-of-care practice should be reported and managed per your institution’s policies and procedures


Adverse events2

Definition of AE

Definition of

Serious AE

Grading

Attribution

Expected vs. Unexpected

List of Expected AEs

Recording of AEs

When to Report

How to Report

Adverse Events

Protocol Section 10.0


Adverse events3

Adverse Events

For additional information on AEs -

  • ACRIN website - Under the Regulatory Resources Tab the ACRIN AE Manual and other useful links can be found

  • ACRIN AE Coordinator –

    Cornelia (Lia) Worley

    [email protected]

    215 574-3236


Audit program

Audit Program

  • On-site visits by ACRIN Auditor(s)

  • Review

    • Regulatory Documents / IRB Binder

    • Study-specific Processes

    • Participant Cases

    • Imaging Processes (with Image Management Center)

    • Facility and Imaging Area Tours

    • Interviews with Key Personnel

    • Adverse Events

    • Follow-up on Monitoring Report(s)

    • Follow-up on prior audit findings


Auditing program

Auditing Program

  • IRB Approvals

    • Initial protocol

    • Amendments

    • Annual reviews

    • Informed consents – initial & revised versions

    • Recruitment & retention materials

    • Participant questionnaires

    • Others as necessary

  • ACRIN Statement of Investigator

  • Site Signature and Responsibilities Log


Audit program1

Audit Program

Process Review

  • Recruitment & Informed Consent

  • Eligibility Evaluation

  • Study Procedures

  • Adverse Event Process

  • CRF Completion


Audit program2

Audit Program

Case Review

Protocol Compliance

Study Procedures

Adverse Event Recording & Reporting

GCP Compliance

Supporting source documents

CRFs completed accurately, completely, and

per CRF instructions

Data corrections

Timely data submission

Data entry accuracy


Image review

Image Review

  • ACRIN Image Management Center

    • Reviews images and imaging data

    • Provides quality and status reports to PDRC prior to monitoring and auditing

  • Monitors and Auditors

    • Review imaging data (collected on study CRFs)

    • Use reports provided by IMC

    • Assess compliance with the protocol

    • Assess for proper completion of imaging

      data collection forms


Follow up

Follow Up

  • Formal report: observations and/or finding

  • Monitoring is on-going throughout the conduct of the trial

  • Additional auditing dependent upon outcomes

  • Findings and observations detailed in report

  • Possible Outcomes  Acceptable, Acceptable with Follow Up, and Unacceptable


Resources

Resources

  • ACRIN

    Links to many useful resources can be found on our website - http://www.acrin.org. To access these resources, click on the ‘ADMINISTRATION’ tab on the home page, then click on ‘REGULATORY RESOURCES’.

  • FDA Information Sheet Guidances http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm

  • ICH E6

    http://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/good_clinical_practices.pdf

  • OHRP http://www.hhs.gov/ohrp/

  • ORI http://ori.dhhs.gov/


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