ACRIN CV Committee ACRIN PDRC ACRIN PA 4008 Protocol and Regulatory Requirements Patricia Atkinson, Quality Control Monitor

ACRIN CV Committee 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

ACRIN CV Committee ACRIN PDRC 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.

ACRIN CV Committee ACRIN PDRC 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)

ACRIN CV Committee ACRIN PDRC 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).

ACRIN CV Committee ACRIN PDRC 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 for assistance.

ACRIN CV Committee ACRIN PDRC 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.

ACRIN CV Committee ACRIN PDRC 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.

ACRIN CV Committee ACRIN PDRC 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:  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.

ACRIN CV Committee ACRIN PDRC 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

ACRIN CV Committee ACRIN PDRC Questions?

ACRIN CV Committee ACRIN PDRC Thank you!