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Clinical Trials Cooperative Group Program Guidelines, August 1996

ATTACHMENT 3 (Revised 8/96)

SUGGESTED FORMAT FOR NON-COMPETING CONTINUATION APPLICATIONS FOR

NCI CLINICAL TRIALS COOPERATIVE GROUP PROGRAM COOPERATIVE AGREEMENTS

The annual non-competing continuation (Type-5) cooperative agreement application serves as a report to the funding agency on the achievements of the awardee in the previous funding period and presents the plan of activity for the upcoming funding period along with the associated cost projections. The application is due two months prior to the anniversary date of the Group award.

Separate applications are required for each cooperative agreement supported by NCI, and thus are usually submitted from the headquarters office, the statistical/data management office and from those funded member institutions with individual cooperative agreements. For Cooperative Groups which have merged functions in one way or another into fewer cooperative agreements, each activity should be separately reported in the relevant application along with its associated budget. Each application begins with the face page and the detailed budget pages as described in the Instructions for the PHS 2590 (Rev. 5/95), Application for Continuation of a PUBLIC HEALTH SERVICE GRANT. The budget presentations for the separate components should be in accord with the support recommended on the NIH Notice of Grant Award for the continuation period and in sufficient detail to assure that NCI staff (CTEP and GAB) are advised of proposed budget commitments. For allowable expenditures see Clinical Trials Cooperative Group Program Guidelines.

A. GROUP HEADQUARTERS/STATISTICAL OFFICE APPLICATION(S)

Please prepare the Group Headquarters/Statistical Office cooperative agreement application(s) according to Instructions for the PHS 2590 (Rev. 5/95) except as noted below:

1. BUDGETS AND BUDGET JUSTIFICATIONS (Form Page 2 and Form Page 3)

The budget section should begin with summary budget pages, followed by separate detailed budgets and justifications for each component or activity including separate budgets/tables for individual consortia. (See Section II VII.2.B. Headquarters (Operations Office) Budget).

2. IMMEDIATELY FOLLOWING FORM PAGE 3, THE FOLLOWING IS REQUIRED:

a. On-site Auditing Activities

The NCI-CTMB Guidelines for On-Site Monitoring of Clinical Trials for Cooperative Groups and CCOP Research Bases require all institutions to be audited at least once every 36 months. In order for NCI staff to review each the Group's compliance with this requirement, each Group should conduct a comprehensive review of its current membership and provide in the non-competing continuation application an accounting in tabular format (see suggested format - Attachment 4) for all institutions to include: (1) date of affiliation with or termination from the Group; (2) accrual for the immediate preceding 36 months broken down by year; (3) the projected accrual for the upcoming year; (4) the date of the institution's last audit; and (5) the date (projected month/year) of the next proposed audit.

In addition, please provide the following information related to the costs of conducting the audits:

  1. For the immediately preceding budget period, the actual total costs (direct and associated indirect) charged to the Headquarters or Statistical Center, as appropriate.
  2. For the correct budget period, the estimated total costs (direct and associated indirect) charged to the Headquarters or Statistical Center, as appropriate. If all audits have been completed, please provide the actual total costs charged.
  3. For the upcoming budget period, the estimated total costs (direct and associated indirect) for conducting the planned audits.
  4. Please provide this information in the Budget justification section. The information may be provided in the format of the Group's choosing.

b. If the Headquarters provides funds to performance sites for accruals (including High Priority and Minority Accrual Initiatives) via per patient reimbursement mechanisms, (e.g., purchased service agreements or subcontracts), the following information must be provided:

  1. For the current budget period, (i) a list of performance sites that received funds to date in that year; and (ii) the total costs provided to each site (direct and indirect) to date in that year; and (iii) the number of patients accrued for each site to date in that year.
  2. For the immediately preceding budget period, (i) a list of performance sites that received funds to date in that year; and (ii) the total costs provided to each site (direct and indirect) to date in that year; and (iii) the total number of patients accrued in that year for each site.
  3. For the upcoming budget period, (i) the estimated number of accruals and (ii) the estimated total costs (direct and indirect) for each performance site.

The above information may be provided in the format of the Group's choosing and should follow the budget justification section of the application.

3. BIOGRAPHICAL SKETCH (Form Page 4)

Include biographical sketches for new participants in administrative and scientific leadership roles only.

Limit to two pages each.

4. OTHER SOURCES OF SUPPORT FOR THE GROUP

  1. Include in the listing all sources of support (both NCI and non-NCI) for the Group's headquarters and/or statistical office for all research activities. For that support which is linked to specific studies, indicate which studies receive this support, the associated dollar amounts and the nature of any costs not normally supported by NCI.
  2. Unmet funding needs: Outline in detail funding needs beyond those which can be met by the Group's committed budget for the upcoming year and which the Group feels are required for its continued function; describe the justification precisely. Requests for additional funds must be for efforts within the Group's approved work scope. How would additional funding affect the quality of research currently in progress? What new initiatives would be possible? Would this represent a one-time request or a continuing obligation?

5. PROGRESS REPORT SUMMARY (Form Page 5) -

ORGANIZATION OF THE APPLICATION ACCORDING TO THE FOLLOWING FORMAT IS SUGGESTED:

a. ADMINISTRATIVE

  1. Achievements: Briefly describe the Group's significant achievements in the past year in its administrative activities. These might include: organizational or structural aspects, data management practices and procedures, statistical approaches, compliance with regulatory requirements, quality assurance practices, efficiencies in protocol development, growth in membership, educational activities, etc., including changes in primary personnel, their roles and responsibilities.
  2. Proposed Activities: Outline planned new initiatives in terms of organizational and administrative activities for the upcoming year for the Group as a whole.
  3. Special Emphasis Issues:
  4. Scientific prioritization - Describe the process used by the Group for setting priorities regarding the use of (limited) Group resources to accomplish its approved work scope.
  5. Ethics and integrity in the conduct of clinical research -
    1. ethics training - Describe current Group procedures for education of Group members regarding the ethical requirements of clinical trials research, including the mechanism (such as the Affirmation of Integrity statement) by which the Group assures that all its members who handle clinical trials data know the Group policy towards scientific misconduct.
    2. conflict of interest policy - Briefly describe Group policies and procedures regarding the evaluation of potential conflicts of interest. Include a table listing Group members to whom the conflict of interest policies are applicable, stating their position in the Group.
    3. procedures in the event of scientific misconduct - Describe Group procedures in the event of detection of scientific misconduct. Describe the instructions given Group members regarding reporting concerns about possible scientific misconduct
  1. Quality of Group data - Describe mechanisms in place which provide quality control of the data set used for Group analyses.
  2. Data and Safety Monitoring Committees - Briefly describe how decisions made by the Group Phase III Data and Safety Monitoring Committee(s) are made independently from study coordinators and involved investigators. Describe the composition of the DSMC.
  3. Group membership and accrual - Describe the following:
    1. Group membership categories, including a complete list, by membership categories, of all performance sites.
    2. Overall accrual to Group studies, separated into therapeutic and non-therapeutic study categories.
    3. Inclusion of women and minorities in clinical trials research. Total Group patient accrual by study shall be reported in the parent Cooperative Group application in accordance with the guidelines for the PHS 2590 (Rev 5/95), pages 8-9, using the table on Form Page 5. Describe, where relevant, initiatives to improve access by underserved populations to clinical trials participation.
    4. Accrual to NCI-designated High Priority Trials, if relevant.
    5. Outreach efforts, including accrual through the Group's utilization of the Cooperative Group Outreach Program (CGOP) and Community Clinical Oncology Program (CCOP) mechanisms, if relevant.

4) Outline the Group's most important problems and proposed solutions.

b. COOPERATIVE GROUP COMMITTEES AND LABORATORIES - PROGRESS REPORT

(organized by Committee: include all committee and laboratory progress reports in the Headquarters application)

  1. Achievements - Summarize the most significant achievements in the past year for each committee or laboratory (limit to one page per committee)
  2. Review of studies - Briefly describe new findings and changes in the status of committee studies.
  3. Membership - Briefly describe changes in the membership of each committee focusing particularly on changes in leadership responsibilities.
  4. Plans - Briefly discuss changes in the research focus of each committee including projected new initiatives, future directions, and priorities.
  5. To aid in the review of your application information for each committee or laboratory should be arranged in a tabular format as shown in sample tables 1 - 3.

c. BIBLIOGRAPHY

  1. Arrange in tabular form such as shown in sample table 4, the Group Bibliography, beginning with the most recent publications, abstracts and presentations. Attach any additional pages required to complete the bibliography. Do not include publications which had complete citations in a previous application.
  2. Arrange in tabular form such as shown in sample table 5, a complete listing of manuscripts and abstracts which have been submitted but not yet published.

d. PERFORMANCE REVIEW

  1. Describe the process by which the performance of each participating institution (members, affiliates, CCOPs, CGOPs, etc.,) is assessed. Include the current ranking of participants by these criteria. How has the evaluation impacted on the funding of the participants?
  2. List all institutions against which disciplinary action (probation, suspension of registration, etc.,) was taken on the basis of a site visit, performance review, etc. Describe circumstances leading to the action and the nature of the action taken.

e. ACCRUAL TABLES

The Headquarters application should provide two types of accrual tables summarizing Group activities (see suggested formats, attached). The first should provide total Group accrual displayed by protocol [sample tables 1 (therapeutic) and 2 (non-therapeutic)]; the second should provide total Group accrual displayed by performance site [sample tables 6 (therapeutic) and 7 (non-therapeutic)].

For sample table 1, Intergroup studies should be separated into two categories: a) those studies for which the Group serves as the coordinating center, and b) the additional studies to which the Group contributes patients. The Intergroup coordinating center is asked to provide in its application complete accrual information for the study with a breakdown by the contributing Groups. A participating Group other than the coordinating center is asked to provide in its application information limited to that Group's activities.

Sample tables 6 and 7 should contain accrual data for the entire Group, in tabular form such that the accrual for each member and its affiliated performance sites are displayed without duplication. Data for performance sites affiliated directly with the Group Headquarters should be displayed with the notation "Headquarters" where the member's name would otherwise be displayed.

Please note that applications from individual Group institutions holding cooperative agreements are to include sample tables 6 and 7 specific for that institution and its affiliates. The Group statistical center should provide the information to the member institution for inclusion in its application.

6. GENDER AND MINORITY INCLUSION (Form Page 5)

The Table on Form Page 5 must be filled out in accordance with the instruction in Section A. 5. a. 3) e) iii) above.

B. GROUP MEMBER INSTITUTION APPLICATIONS

In some Groups, member institutions receive cooperative agreements directly from NCI, thus requiring separate grant applications to be submitted by the member institution with the guidance of the Group leadership. Please prepare the member institution applications according to the Instructions for the PHS 2590 (Rev. 5/95), Application for Continuation of a PUBLIC HEALTH SERVICE GRANT, except as noted below:

  1. Briefly describe any changes in institutional profile, personnel, or affiliations relevant to the accrual of patients onto Group studies.
  2. Discuss the scientific contribution of the member institution in terms of specific study leadership, pilot study contribution, authorship, Group meeting participation, etc.
  3. Briefly describe the participation of personnel in administrative activities of the Group.
  4. The member institution application should include tables displaying institutional/affiliate accrual to therapeutic (Table 6) and non-therapeutic (Table 7) Group protocols by Phase; these should be prepared by the Group statistical office and supplied to the member institution for inclusion in the application.
  5. Gender and Minority Inclusion: Patient contribution by study will be reported in the parent Cooperative Group application in accordance with the instructions in the PHS 2590, Rev 5/95, therefore, institutional applicants are not required to report the study population by protocol. However, the table at the bottom of Form Page 5 of the PHS 2590 should be filled in, providing a summary of institutional accrual to Group studies for the following time period: either a) the twelve month period ending one month before the receipt date of this application, or b) the most recent calendar year. Institutional applications should discuss special resources which it provides to the Group in terms of special patient populations and affiliations. Include minority and medically under-served populations, as appropriate. Please provide written explanations of local demographics or other obstacles which may influence the ability of your institution to recruit women and minority patients in representative proportions, and efforts to overcome such obstacles.
  6. Budget and Budget Justification: Complete in accord with the instruction sheet for PHS 2590 (Rev. 5/95). Applicants requesting awards which are larger than the committed level should provide detailed justification for any increases and should enclose a supporting letter from the Group Chairperson.

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