ACRIN PDRC
ACRIN PA 4008
Protocol and Regulatory
Requirements
Patricia Atkinson, Quality Control Monitor
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ACRIN PDRC
Meet the Team
Maria Oh, Director
James Concannon, Protocol Associate
Martha Heckel, Protocol Associate
Patricia Atkinson, Quality Control Monitor
Mary Kelly-Truran, Quality Control Auditor
Chris Steward, Quality Control Auditor
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Regulatory Documentation Required
for Site Participation
 Protocol specific IRB Approval Letter;
 IRB-approved, site-specific Informed Consent Form;
 IRB Approval Letter (s) for all recruitment materials when
required by the site IRB;
 IRB Approval Letters for all revised Informed Consent Forms,
amendments and annual approvals;
 IRB Membership List, if available, or a memo from IRB
indicating membership meeting federal regulatory compliance.
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Adverse Event Reporting
The site Principal Investigator is responsible for the assignment of
grade (severity level) and attribution (causation) of each Adverse
Event.
(Please review protocol section 10.0 for definitions and details)
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Adverse Event Reporting
Routine vs. Expedited reporting:
 Routine reporting is defined as documentation of Adverse Events on the
ACRIN AE CRF. Once submitted to ACRIN this data will be reported to the
Data and Safety Monitoring Committee (DSMC), CDUS, and used in the
final study report.
 Expedited reporting Expedited reporting is defined as immediate
notification of ACRIN within the specified timeframe outlined in the protocol
and in Table A (page 31) and completion of the ACRIN SR CRF. Routine
reporting requirements also apply(completion of ACRIN AE CRF) .
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Adverse Event Reporting
 Prompt reporting of AEs is the responsibility of each
investigator, clinical RA, and/or nurse engaged in clinical
research. Please refer to protocol section 10.0 for specific details
about Adverse Events.
 ACRIN will collect and report adverse events and serious
adverse events per protocol section 10.8 (please review).
 Anyone uncertain about whether a particular AE should be
reported should contact ACRIN headquarters at 215-717-2763
for assistance.
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ACRIN Monitoring and Auditing Programs
 To ensure study integrity and quality through data verification
 To ensure safety and welfare of study participants
 Continual assessment and review to ensure accuracy and
completeness of study data and compliance through:
 Review of Regulatory Requirements;
 Review or Protocol Requirements;
 Review of Participant Charts.
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ACRIN Monitoring Program
 Monitoring at ACRIN consists of a remote review of all
regulatory documents and participant chart(s) for source
verification of the study data.
 Monitoring reviews are implemented at various time points or
rounds from initial participant enrollment and throughout the
conduct of the trial.
 The number of participant charts to be reviewed for each round
of monitoring will be determined by:
 study design;
 the number of participants enrolled at each site;
 scientific endpoints.
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ACRIN Auditing Program
 Audits will be conducted on site.
 The number of participant charts to be reviewed at each audit
visit will be determined by the auditor.
 The timing of initial on-site audit will depend on several factors
including the following:
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rate of accrual (both study-wide and site-specific);
the number of evaluable participants enrolled at an individual site;
the status of the protocol and pending amendments;
at least 3 months after an institution has been monitored;
after the number of evaluable participants reaches 30% of targeted accrual,
either study-wide and/or site-specific;
 closure of the study to accrual;
 site-specific circumstances.
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ACRIN Auditing Program
 Audits can be conducted more frequently at the discretion of the
protocol team;
 Subsequent audits will be scheduled per the outcome of the
initial audit;
 Major discrepancies will be forwarded to the appropriate
oversight body within ACRIN;
 The ACRIN Audit Manual is available online at
www.acrin.org/pdrc.aspx.
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Questions?
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Thank you!
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