Nci s role as sponsor of acrin clinical trials regulatory considerations
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American College of Radiology Imaging Network Fall Meeting. NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations. Barbara A. Galen, MSN, CRNP, CNMT Cancer Imaging Program, National Cancer Institute, U.S.A. October 2-5, 2008 Pentagon City, Arlington, Virginia. Outline.

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American College of Radiology Imaging Network

Fall Meeting

NCI’s Role as Sponsor of ACRIN Clinical Trials: Regulatory Considerations

Barbara A. Galen, MSN, CRNP, CNMT

Cancer Imaging Program, National Cancer Institute, U.S.A.

October 2-5, 2008

Pentagon City, Arlington, Virginia


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Outline

  • NCI’s Relationship to ACRIN- sponsor and grantee

  • Basis for regulation and oversight

  • Key U.S. regulatory groups and regulations

  • Cornerstones of government oversight

    • Dr. Anna Edouard: Current AE reporting process

    • Ms. Shanda Finnigan: New AdEERS imaging pathway for electronic AE reporting


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Division of Cancer Treatment and Diagnosis

Office of the Director, DCTD

Biometric Research Branch

Cancer Therapy Evaluation Program

Cancer

Imaging Program

Radiation Research Program

Cancer Diagnosis Program

Developmental Therapeutics Program


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Sponsor and Grantee: Cooperative Agreement- linked U01’s

  • Partnership

  • Stewardship

    • Advice

    • Technical assistance

    • Coordination

    • Programmatic/scientific functions

  • Oversight of quality assurance and monitoring


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Basis for regulation/oversight

  • To protect and ensure patient safety and data accuracy & validity

  • Principles of bioethics (The Belmont Report)

    • Beneficence

      • Duty to protect the welfare of participants

        • Risk/benefits to individuals and communities

        • Study design? Valid Findings? If not, NO BENEFIT

    • Respect for persons

      • Duty to respect autonomous persons, their choices, and their information

        • Informed consent/Privacy of persons and confidentiality of information/Voluntary

        • HIPAA

    • Justice

      • Duty to distribute benefits and burdens fairly

        • Fair selection of individual/populations/ opposite is exploitation


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U.S. Regulations

  • 1991: adopted by 17 US federal agencies as “Common Rule”

    • CFR Title 45 Part 46 Protection of Human Subjects Revised June 23, 2005

  • 21 CFR 50 and 56

  • Health Insurance Portability and Accountability Act 1996 (HIPAA)

  • Office for Human Research Protections (OHRP)

  • Food and Drug Administration (FDA)

  • Centers for Medicare and Medicaid Services (CMS)

  • Office of Civil Rights (OCR)


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Government Oversight

The Common Rule (Title 45 CFR Part 46, Subpart A)

  • Governed by Office for Human Research Protections (OHRP) – 17 Fed Dept /Agencies

  • Enforced by Office of Civil Rights (OCR)

    Sets standards for

  • Informed Consent Process

  • Formation and function of Institutional Review Board’s

  • Involvement of prisoners, children, and other vulnerable groups

    NIH and OHRP together: strengthened in 2000

  • Education and Training in human subjects protection

  • Data and safety monitoring plans-all /boards for Phase III trials

  • Audit informed consent process

  • Clarify regulations regarding conflict of interest


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Government Oversight

  • Title 21 CFR Parts 50 and 56

    • Enforced by the Food and Drug Administration (FDA)

    • IRB review

    • Informed consent

    • Participant protection

      Apply to any clinical trial that involves

      • Investigational drug or imaging agent

      • Biological product, or

      • Device regulated by FDA- regardless of Federal Funding

        Periodically inspects IRB records and operations


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Protecting Participants

  • Protection of Participants before the Trial Begins

    • Scientific Review by the Sponsor

      • Significance, Approach, Innovation, Investigator, Environment

    • Institutional Review Board (IRB) Approval

    • Informed Consent Document/Process

      • Legal, regulatory, ethical concept


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Protecting Participants

  • Protecting Participants During a Clinical Trial

    • Informed Consent Process

    • IRB- approval/monitor progress

    • DSMB-monitoring/oversight

    • Quality Assurance Monitoring

      • Data quality/integrity

      • Auditing

      • Adverse Event Reporting


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Resources on the Web

  • Cancer Imaging Program (CIP) http://imaging.cancer.gov

  • The NCI Clinical Trials http://www.cancer.gov/clinicaltrials

  • Human Subject Protections Education-web-based http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

  • CFR Title 45 Part 46 Protection of Human Subjects Revised June 23, 2005

    http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html

  • 21 CFR 50 and 56 http://www.access.gpo.gov/nara/cfrwaisidx_01/21cfr50_01.html Also see sections 12.1.1 and 12.1.2

    Agencies

    FDA http://www.fda.gov/

    CMS http://www.cms.hhs.gov/

    OHRP http://www.hhs.gov/ohrp/

    OCR http://www.hhs.gov/ocr/hipaa


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NCI Contacts

  • Ms. Irenna Zubal 301-496-9531 zubalire@mail.nih.gov

  • Ms. Barbara Galen 301- 496-9531 bgalen@mail.nih.gov

  • Dr. Lalitha Shankar 301- 496-9531

    shankarl@mail.nih.gov


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American College of Radiology Imaging NetworkFall Meeting

Current SAE Reporting Process: Cancer Imaging Program Non-IND Studies

Dr. Anna Edouard

Senior Safety and Pharmacovigilance Specialist, Contractor

Technical Resources International, Inc

October 2, 2008


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CIP SAE Reporting

Clinical Site

Requests

Information

(source

documents)

Submits SAE report

TRI

Notifies (SAE receipt, info request)

Triages packet(SAE report, source documents)

ACRIN

Assesses

SAE report

CIP


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CIP SAE Reporting

  • Clinical site fills out appropriate sections of the SAE submission form

    • Note: For a 24-hour phone notification, follows up with a faxed SAE submission within 5 business days.

  • Faxes SAE submission form with any additional information (supporting source documents) to (301) 897-7402, attention CIP SAE Team.


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CIP SAE Reporting

  • Clinical site follows up with an email to CIPSAEReporting@tech-res.com notifying team that an SAE form has been faxed.


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CIP SAE Reporting

  • TRI retrieves the faxed documents (SAE report), notifies ACRIN and the CIP staff/ Medical Monitor (MM) of receipt, and triages the packet.

  • TRI requests from the site any pertinent medical information necessary to evaluate the report.

  • Sends SAE report, supporting documents, and newly-created tracking record to CIP staff via email for assessment.


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CIP SAE Reporting

  • CIP staff reviews SAE report, signs Part A of tracking record electronically, and sends back to TRI who logs in the information and status of the report.

  • CIP may request that TRI send a follow-up query to the site for additional information. ACRIN and CIP are copied on any emails sent to site requesting additional information.


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CIP SAE Reporting

  • Once TRI is satisfied that all pertinent information has been received, the SAE report, tracking record, and supporting documents are forwarded via email to the MM for assessment. MM completes Part C of the tracking record and signs electronically. MM emails this tracking record back to TRI.


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CIP SAE Reporting

  • Upon receipt of tracking record via email, TRI completes Part D and files the completed report electronically. The original hardcopy is sent to CIP for filing.


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Lessons Learned

  • Follow-up email from clinical site to TRI after submission of paper document is inconsistent.

  • Situations in which there are 2 or more SAEs being reported require a separate report to be completed for each event.

  • Attributions for each SAE must be indicated on submitted reports (select 1-5 to indicate unrelated, unlikely, possible, probable, definite).


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Contact Information

  • Anna Edouard, MD

    Tel.: 301-897-7447

    Fax: 301-897-7402

    Email: aedouard@tech-res.com

  • James Murray, PhD

    (CTEP AE Team Manager)

    Tel.: 301-897-1717

    Fax: 301-897-7402

    Email: jmurray@tech-res.com


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Contact Information

  • AdEERS Helpdesk (AdEERSMD):

    Tel.: 301-897-7497

    Email: adeersmd@tech-res.com

  • CIP SAE Reporting Desk

    Fax: 301-897-7402

    Email: CIPSAEReporting@tech-res.com

  • Adverse Event Expedited Reporting System (AdEERS)

    http://ctep.info.nih.gov Find clinical trial resources on right-hand side and click on AdEERS.


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American College of Radiology Imaging NetworkFall Meeting

AdEERS: New electronic imaging pathway CIP/CTEP/CTIS

Shanda Finnigan, RN, BSN, CCRC

Health Program Specialist

Contractor

CTEP, DCTD, NCI

October 2, 2008


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CTEP’s Adverse Event page: http://ctep.cancer.gov/reporting/adeers.html


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AdEERS Application: https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main$.startup


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Contact Information

  • Medical Questions/Help

    • email: adeersmd@tech-res.com

    • phone: (301) 897-7497

    • fax: (301) 230-0159

  • Technical Questions/Help

    • email: ncictephelp@ctep.nci.nih.gov

    • phone: 1-888-283-7457

    • fax: (301) 948-2242

  • Shanda Finnigan, RN, BSN, CCRC

    • email:finnigas@mail.nih.gov