CTRU Request Form

When is a CTRU Request Form required?

If you are conducting a study and would like to use any of the participant interaction resources or the clinical lab for sample processing, you must complete a CTRU Request Form through Study Navigator. This is required for all:

• Adult Studies
• Child Health Studies
• Cancer Protocols to be Performed at the CTRU
• CTRU services at the 1070 Arastradero Road Research Clinic (research sample acquisition and processing)

Reminder: Investigators must submit a revision to the IRB prior to initiating any modification to the original protocol. This includes changes in treatment plan, patient eligibility requirements, or exclusion criteria.

Protocol Review

Protocol applications are reviewed for CTRU resource utilization by CTRU staff — administration, nursing, laboratory, dietary. The Chair of the Scientific Review Committee (SRC) will determine if a scientific review is required.

Scientific Review

Stanford faculty-initiated studies that have not had other peer review will be assigned for medical/scientific review by the SRC Chair.

Requests that require Scientific Review must be received a minimum of three weeks prior to the Committee's scheduled meeting. (SRC Committee meets the 4th Tuesday of each month.)

The SRC reviewer will transmit questions and comments to the P.I. of the proposed study, and will recommend one of the following actions to be voted on by the SRC:

• Approve
• Approve contingent on response by P.I.
• Disapprove
• Defer pending major revisions or other considerations

Note: The CTRU Advisory Committee requires the PI or his/her responsible, knowledgeable representative to attend the committee review meeting. The CTRU will contact both the PI and the contact person named in the application on the Monday prior to the Advisory Committee review meeting. If a member of the study team does not attend the meeting and questions remain unanswered, the protocol will be deferred to the following month.

Scientific Review Exemptions

The following protocols are exempt from medical scientific review by the SRC:

• Cancer protocols, reviewed by the Scientific Review Committee of the Cancer Center
• Studies which have been peer-reviewed via NIH or non-profit foundation grants
• Industry sponsored trials

Cancer Center Studies Protocol Review

Cancer Center Studies require the same CTRU Request Form as non-cancer studies. In addition to completing the Request Form, you must also apply for review by the Cancer Clinical Trials Office (CCTO) Scientific Review Committee (SRC).

Following Approval of Request Form

• Call the CTRU Nurse Manager at 723-6973 to arrange an in-service for the CTRU staff prior to patient admission.

Key Points

• A CTRU Request Form is required for all CTRU services and resources.
• Submit your completed CTRU Request Form at least three weeks prior to scheduled Scientific Review Committee Meetings.