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
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
• 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 7170936
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
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
• 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 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 Events
Protocol Section 10.0
1. Definition of AE
6.
2. Definition of
7.
Serious AE
8.
3. Grading
9.
4. Attribution
5. Expected vs. Unexpected
List of Expected AEs
Recording of AEs
When to Report
How to Report
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
• 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
• 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 Program
Process Review
•
•
•
•
•
Recruitment & Informed Consent
Eligibility Evaluation
Study Procedures
Adverse Event Process
CRF Completion
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
• 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
• 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
• 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_pra
ctices.pdf
• OHRP
http://www.hhs.gov/ohrp/
• ORI
http://ori.dhhs.gov/