Regulatory oversight for ACRIN is provided by the National Cancer Institute’s Cancer Imaging Program (NCI-CIP) and the ACR Institutional Review Board (IRB). ACRIN’s Protocol Development and Regulatory Compliance (PDRC) Department monitors regulatory compliance for all ACRIN sites. Also, all protocol development and regulatory compliance resources can be found on the Regulatory Resources page of the Web site.
Required Regulatory Materials
Before a trial can open at a site, several regulatory requirements must be met:
Some regulatory materials must be submitted as part of the protocol-specific application:
Proof of OHRP Federalwide Assurance
FDA Form 1572
CVs for principal investigators
Proof of medical license (as appropriate)
All personnel working on a protocol must provide proof of human research subject protection training.
Sites must provide ACRIN with proof of institutional IRB approval of the protocol, the site-specific consent form, and recruitment materials.
For ongoing studies, sites must provide ACRIN with proof of annual renewal of IRB approval.
Remote monitoring, which is conducted by mail, helps ACRIN PDRC staff review site performance promptly and assist with any problems. The process is for educational purposes to enhance study compliance and data integrity.
- After sites have registered one or two cases, ACRIN regulatory staff will initiate the monitoring process per the protocol-specific monitoring plan.
- The site research associate submits requested documents (including IRB documentation, informed consent content, and case records) for review by ACRIN staff.
On-site audits are an integral part of ACRIN’s quality assurance and regulatory compliance programs.
- ACRIN audits are mandated and monitored by the National Cancer Institute’s Cancer Imaging Program (NCI-CIP). They validate study data, verify regulatory compliance, identify scientific misconduct, and serve as an educational resource for sites.
- Audits are scheduled per protocol-specific guidelines, usually 18 months after a site’s first enrollment of a participant.
- If a site participates in multiple ACRIN trials, several trials may be audited at one time.
- Several weeks before an audit, the principal investigator will be provided with a list of cases to be reviewed. At least one unannounced case will also be reviewed.
Adverse Event Reporting
An adverse event (AE) is any unfavorable medical occurrence in a participant that is not necessarily caused by the study intervention.
- Prompt reporting of AEs is the responsibility of every investigator and RA involved in ACRIN research.
- Full AE reporting information can be found in every ACRIN protocol and in the ACRIN Adverse Event Manual.