Step 2: Conducting a Cancer Prevention Clinical Trial
Roles and Responsibilities
Staff Roles and Responsibilities
Roles and Responsibilities of the NCI and the Prevention Consortia components and staff are depicted in the DCP Prevention Consortia Organization Chart (doc, 30kb).
The Contractor Organization for Prevention Clinical Trials Consortium Management (doc, 37kb) provides descriptions of key Consortium components and staff.
The DCP Organization for Prevention Clinical Trials Consortia Management (doc, 44kb) provides descriptions of key Consortium components and staff within the Division of Cancer Prevention and the National Cancer Institute.
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FDA Roles and Responsibilities
Any clinical trial that involves an FDA-regulated drug or device, regardless of whether the trial receives Federal funding, is subject to FDA regulations on participant protection in clinical trials. The agency periodically inspects Institutional Review Board records and operations to certify the adequacy of approvals, participant safeguards, and conduct of business.
FDA manages the approval process for new drugs and new indications and formulations for previously approved drugs. The Center for Drug Evaluation and Review (CDER) and the Center for Biologics Evaluation and Review (CBER) are the specific divisions responsible.
The institution holding the funding agreement with the NCI is considered the lead organization. Usually the principal investigator is affiliated with it. The lead organization ensures that organizations accruing patients to a trial comply with Federal regulations, Good Clinical Practice Guidelines, and the study protocol.
An organization that, by agreement with the NCI and the lead organization participates in a clinical trial by accruing patients is referred to as a participating organization.
As a sponsor of a clinical trial, the NCI's Division of Cancer Prevention is responsible for ensuring that clinical trials proceed safely and according to protocol from the initial safety studies to clinical testing.
DCP has contracted with Westat, a clinical research organization, to conduct study site monitoring visits at the lead organizations for ensuring clinical trials are in compliance with FDA regulations and applicable policies, patients are treated safely and according to the protocol, and accrual goals and time lines are met.
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OHRP Roles and Responsibilities
The Office for Human Research Protections (OHRP) safeguards participants in federally funded research and provides unity and leadership for many federal departments and agencies that carry out research involving human participants.
OHRP is responsible for the oversight of compliance of institutions receiving awards with the Department of Health and Human Services (HHS). The office evaluates all written allegations or indications of noncompliance with HHS regulations. Institutions engaged in human subject research conducted or supported by HHS, must provide written Assurances of Compliance.
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