Transcript CIP SAE Reporting

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
• 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
Division of Cancer Treatment and Diagnosis
Office of the Director, DCTD
Biometric Research Branch
Cancer
Radiation
Cancer
Research
Diagnosis
Program
Program
Therapy
Developmental
Cancer
Evaluation
Therapeutics
Imaging
Program
Program
Program
Sponsor and Grantee: Cooperative
Agreement- linked U01’s
• Partnership
• Stewardship
– Advice
– Technical assistance
– Coordination
– Programmatic/scientific functions
• Oversight of quality assurance and
monitoring
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
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)
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
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
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
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
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/humanparti
cipant-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
NCI Contacts
• Ms. Irenna Zubal 301-496-9531
[email protected]
• Ms. Barbara Galen 301- 496-9531
[email protected]
• Dr. Lalitha Shankar 301- 496-9531
[email protected]
American College of Radiology
Imaging Network
Fall 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
CIP SAE Reporting
Clinical Site
Requests
Information
Submits SAE report
(source
documents)
TRI
Notifies (SAE
receipt, info request)
Triages packet (SAE
report, source documents)
ACRIN
Assesses
SAE report
CIP
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) 8977402, attention CIP SAE Team.
CIP SAE Reporting
• Clinical site follows up with an email
to [email protected]
notifying team that an SAE form has
been faxed.
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.
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.
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.
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.
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).
Contact Information
• Anna Edouard, MD
Tel.: 301-897-7447
Fax: 301-897-7402
Email: [email protected]
• James Murray, PhD
(CTEP AE Team Manager)
Tel.: 301-897-1717
Fax: 301-897-7402
Email: [email protected]
Contact Information
• AdEERS Helpdesk (AdEERSMD):
Tel.: 301-897-7497
Email: [email protected]
• CIP SAE Reporting Desk
Fax: 301-897-7402
Email: [email protected]
• Adverse Event Expedited Reporting
System (AdEERS)
http://ctep.info.nih.gov Find clinical trial resources
on right-hand side and click on AdEERS.
American College of Radiology Imaging
Network
Fall Meeting
AdEERS: New electronic
imaging pathway
CIP/CTEP/CTIS
Shanda Finnigan, RN, BSN, CCRC
Health Program Specialist
Contractor
CTEP, DCTD, NCI
October 2, 2008
CTEP’s Adverse Event page: http://ctep.cancer.gov/reporting/adeers.html
AdEERS Application: https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main$.startup
Contact Information
• Medical Questions/Help
– email: [email protected]
– phone: (301) 897-7497
– fax: (301) 230-0159
• Technical Questions/Help
– email: [email protected]
– phone: 1-888-283-7457
– fax: (301) 948-2242
• Shanda Finnigan, RN, BSN, CCRC
– email: [email protected]