Clinical Trials Cooperative Group Program Guidelines, August 1996 Guidelines Document (MS Word Doc) Guidelines Document (PDF) These guidelines explain the policies and procedures of the National Cancer Institute (NCI) with respect to the Clinical Trials Cooperative Group Program of the Division of Cancer Treatment and Diagnosis (DCTD). Some of these guidelines reflect Department of Health and Human Service requirements for federally funded clinical research while others are the result of a consensus among NCI staff and qualified extramural clinical investigators. These guidelines have been updated to reflect current practices. Although further evolution of these guidelines is inevitable, it is hoped that the codification of NCI policies and procedures will continue to be of practical value to participants in, and reviewers of, DCTD-supported clinical trials research. Richard S. Ungerleider, M.D. Chief, Clinical Investigations Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute National Institutes of Health Executive Plaza North, Room 741 6130 Executive Boulevard, MSC 7436 Bethesda, MD 20892-7436 TABLE OF CONTENTS I. Introduction II. Purpose of the Cooperative Groups III. Goals of Cooperative Group Research IV. Study Development V. Quality Control, Study Monitoring, Independent Data and Safety Monitoring Committees and On-site Audits VI. General Operational Considerations VII. Application Preparation - Special Instructions VIII. Peer Review IX. Miscellaneous Administrative Considerations X. Terms and Conditions of Award ATTACHMENT 1 - Sample Format for Modality Committee Summary of Activities ATTACHMENT 2 - Sample Format for Member Institution Summary of Activities ATTACHMENT 3 - Suggested Format for Non-competing Continuation Applications ATTACHMENT 4- Suggested Format for Reporting On-site Auditing Activities Forms and Tables: Sample Table 1: Accrual Summary for Protocols Open to Accrual During Reporting Period [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 2: Accrual Summary for Companion (i.e., Non-Therapeutic) Studies [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 3: Patients Being Followed as of One Month Prior to Application Deadline [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 4: Group Bibliography [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 5: Submitted Manuscripts and Abstracts Not Yet Published [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 6: Patient Accrual by Institution for Each Therapeutic Protocol [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Sample Table 7: Patient Accrual by Institution for Each Non-Therapeutic Protocol [ Acrobat (.pdf) format ]   [ MS Word (.doc) format ] Date Last Modified: 11 June 1998

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