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Clinical Trials Cooperative Group Program Guidelines, August 1996IX. MISCELLANEOUS ADMINISTRATIVE
CONSIDERATIONS IX.1. CTEP Staff Administration IX.1. CTEP STAFF ADMINISTRATION Within CTEP, major scientific policy and programmatic decisions concerning the Clinical Trials Cooperative Group Program are made on a corporate basis, with involvement by the Program Director, the Branch Chiefs and Section Heads, the CTEP scientific liaison to the Group, and the Associate Director, as necessary and appropriate. Actual programmatic administration is the responsibility of the Program Director, who assures uniformity of implementation across the various Groups. IX.2. GRANTS MANAGEMENT STAFF ADMINISTRATION
A Grants Management Specialist of the Grant Administration Branch, NCI, is responsible for the fiscal and administrative aspects of each application and award. The specialist works closely with the CTEP Program Director to assure that appropriate science is funded in accordance with applicable laws, regulations, policies and peer review recommendations and to the extent that the budget allows and NCI priorities dictate. IX.3. NON-COMPETING CONTINUATION APPLICATIONS
Approximately 4 months prior to the award's anniversary date, each cooperative agreement awardee receives a face page for form PHS 2590 (Rev. 5/95) from NIH. CTEP staff will supply a suggested format (Attachment 3) to be followed for the Progress Report Summary section of the application ("Format for Non-Competing Continuation Applications for NCI Clinical Trials Cooperative Group Program Cooperative Agreements"). The intent is to focus the awardee's reporting on the specific information needed for an adequate evaluation of progress. The format will vary depending on the operational component (Headquarters, Statistical/Data Management, or Primary Member), but will be similar to that described above for the competing application. IX.4. NON-COMPETING CONTINUATION BUDGET
ADJUSTMENTS Adjustments in the relative funding of the various components of a Cooperative Group at the time of non-competing continuation award represent one method of providing the Group leadership with flexibility in allocating the total resources supporting the Group. Such adjustments have the potential to provide the Group and the NCI with a program that ensures that those funds are put to their best use. Requests for the adjustments are initiated by the leadership of the Cooperative Group. They involve negotiation of awards by the NCI to reflect the increased or decreased level of activity at an institution. The effect of any such adjustments may be reflected in the adjustments to the previously committed level of future years' awards. Authority to effect an adjustment rests with NCI Grants Management staff, who act in conjunction with the Program Director. Initial budget recommendations for subsequent years are based upon the funding level for the competing year. Increases or decreases in cooperative agreement funding may be made on the basis of changes in performance relative to that approved in the last competing application or in the current year. Funds may be awarded upon demonstration of satisfactory progress as detailed in each non-competing continuing application. They are always, of course, subject to the availability of funds. Thus, funding levels can be increased or reduced because of increments or decrements in performance on the part of the cooperative agreement awardee, or the Group as a whole, or a change in the funds available to the government for distribution. IX.5. CHANGES OF AWARDEE INSTITUTION Only under exceptional circumstances will NCI permit transfer of a primary membership cooperative agreement from one institution to another, as such a transfer would be without the benefit of peer review of the recipient institution. The Program Director and the Grants Management Specialist should be consulted for further advice if such a request is contemplated by the Group. IX.6 TRANSFER OF GROUP MEMBERSHIP Only under exceptional circumstances will NCI permit the transfer of institutional membership from one Cooperative Group to another, as the institutional awardee has undergone peer review only in the context of participation within the original Group. In all cases the transfer must be mutually acceptable to both involved Groups and to the NCI. Data submission to the original Group remains the responsibility of the institution. IX.7. MULTIPLE GROUP MEMBERSHIPS Membership of a single institution in two or more Cooperative Groups having largely overlapping research interests and objectives is inappropriate and will be permitted by NCI only on an exception basis. This policy is not intended to prohibit or discourage participation of members of an adult multi-disease, multi-modality group in one or more subspecialty Groups. In such cases, however, particular attention must be given to lines of patient referral and the avoidance of any possibility of selection bias or dual protocol availability for a single patient population at the institution. IX.8. PIs NOT EMPLOYEES OF AWARDEE ORGANIZATION If the PI is not an employee of the awardee organization there must be a formalized agreement in writing delineating the PI's responsibilities. The PI must have a formal appointment with the applicant organization, which is characterized by an official relationship between the organization and the individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the individual's official organizational relationship must entail sufficient opportunity and physical resources for the PI to carry out his/her responsibilities for the overall scientific and technical direction of the project and for the organization to provide administrative and financial oversight of the project. Each competing application must include an explanation of the arrangement in sufficient detail to permit evaluation prior to award. IX.9. INDUSTRY/GROUP/NCI INTERACTIONS It is appropriate for the Cooperative Group to conduct clinical trials of interest to, and partially supported by, a pharmaceutical firm, provided that the trials have scientific merit in the context of the national research priorities, and are consistent with the overall goals of the Group. A formal policy statement in this regard has been developed by the CTEP, the Cooperative Groups, and representatives of the pharmaceutical industry. It addresses such issues as trial planning, protocol review, resources provided by the private sector for trial conduct, and data rights, confidentiality, and publications. For further information, refer to Appendix 1, "Relationships Between Pharmaceutical Industry and Therapeutic Trials in the Clinical Cooperative Groups Supported by the National Cancer Institute", contained in the Investigator's Handbook, published by NCI, October 1993. In addition, CTEP will provide a suggested protocol section to address intellectual property rights and proprietary data issues. Information on pharmaceutical industry support for NCI
supported studies must be included on the "Other
Support" page of the application. If program income is
earned it must subsequently be reported and accounted for in
accordance with the instructions on the annual financial status
report (PHS Form 269). |
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