Policy on the Issuance of Waivers for Protocol Deviation(s)

Staff in the Cancer Therapy Evaluation Program (CTEP) occasionally receive calls from investigators requesting that certain criteria in a CTEP-approved protocol be waived so a particular patient can be entered or modifications be made to the original treatment plan. In most cases, these waivers relate to the initial eligibility criteria or treatment plans established when the protocol was written and before patient recruitment begins. Granting waivers for protocol deviations has been handled different at CTEP depending on which program staff is contacted. This has led to confusion within CTEP and among the extramural investigators and has occasionally led to patients being judged ineligible during an on-site audit when proper documentation is not available. In order to avoid these situations, CTEP has adopted the following policy related to issuance of waivers for protocol deviations:

CTEP will not issue or approve any waivers for protocol deviations.

This policy applies to all components of CTEP-approved protocols, including eligibility criteria, treatment schedules, dose modifications, toxicity assessment, response criteria, and statistical aspects.

If a change to a CTEP-approved protocol is necessary, the Protocol Chairman may submit an amendment to the protocol. The amendment must be approved in writing by CTEP prior to its implementation (see amendment submission guidelines). An amendment must be submitted and approved by the local Institutional Review Board (IRB) in accordance with their local guidelines for amendment submission and approval prior to submission to CTEP for review. For the Cooperative Groups, amendments should be submitted to CTEP for review prior to sending to local IRBs. CTEP staff will be available to answer questions regarding a particular patient and to help guide an investigator in the best approach to deal with a specific problem.

Approved May 15, 1996; Revised September 3, 1996