CTEP Multicenter Guidelines for Protocols NOT Conducted Through the CTSU/OPEN

Responsibility of the Protocol Chair

• The Protocol Chair will be the single liaison with the CTEP Protocol and Information Office (PIO). The Protocol Chair is responsible for the coordination, development, submission, and approval of the protocol as well as its subsequent amendments. The protocol must not be rewritten or modified by anyone other than the Protocol Chair. There will be only one version of the protocol, and each participating institution will use that document. The Protocol Chair is responsible for assuring that all participating institutions are using the correct version of the protocol.
• The Protocol Chair is responsible for the overall conduct of the study at all participating institutions and for monitoring its progress. All reporting requirements to CTEP are the responsibility of the Protocol Chair.
• The Protocol Chair is responsible for the timely review of Adverse Events (AE) to assure safety of the patients.
• The Protocol Chair will be responsible for the review of and timely submission of data for study analysis.

Responsibilities of the Coordinating Center

• Each participating institution will have an appropriate assurance on file with the Office for Human Research Protection (OHRP), NIH. The Coordinating Center is responsible for assuring that each participating institution has an OHRP assurance and must maintain copies of IRB approvals from each participating site.
• Prior to the activation of the protocol at each participating institution, an OHRP form 310 (documentation of IRB approval) must be submitted to the CTSU Regulatory Office along with any other protocol-specific regulatory documentation required by that study. The CTSU Regulatory Office will track receipt in the CTSU Regulatory Support System (RSS) and, once all requirements are met, set the institution status to "approved" in the RSS.
• The Coordinating Center is responsible for central patient registration. The Coordinating Center is responsible for assuring that IRB approval has been obtained at each participating site prior to the first patient registration from that site.
• The Coordinating Center is responsible for the preparation of all submitted data for review by the Protocol Chair.
• The Coordinating Center will maintain documentation of AE reports. There are two options for AE reporting: (1) participating institutions may report directly to CTEP with a copy to the Coordinating Center, or (2) participating institutions report to the Coordinating Center who in turn report to CTEP. The Coordinating Center will submit AE reports to the Protocol Chair for timely review.
• Audits may be accomplished in one of two ways: (1) source documents and research records for selected patients are brought from participating sites to the Coordinating Center for audit, or (2) selected patient records may be audited on-site at participating sites. If the NCI chooses to have an audit at the Coordinating Center, then the Coordinating Center is responsible for having all source documents, research records, all IRB approval documents, NCI Drug Accountability Record forms, patient registration lists, response assessments scans, x-rays, etc. available for the audit.

Inclusion of Multicenter Guidelines in the Protocol

The protocol must include the following minimum information:

• The title page must include the name and address of each participating institution and the name, telephone number and e-mail address of the responsible investigator at each participating institution.
• The Coordinating Center must be designated on the title page.
• Central registration of patients is required. The procedures for registration must be stated in the protocol.
• Data collection forms should be of a common format. Sample forms should be submitted with the protocol. The frequency and timing of data submission forms to the Coordinating Center should be stated.
• Describe how AEs will be reported from the participating institutions, either directly to CTEP or through the Coordinating Center.
• Describe how Safety Reports and Action Letters from CTEP will be distributed to participating institutions.

Agent Ordering

• Except in very unusual circumstances, each participating institution will order DCTD-supplied investigational agents directly from CTEP. Investigational agents may be ordered by a participating site only after the initial IRB approval for the site has been forwarded by the Coordinating Center to the CTEP PIO.