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Clinical Trials Cooperative Group Program Guidelines, August 1996VII. APPLICATION PREPARATION - SPECIAL
INSTRUCTIONS
VII. 1. General Information Financial assistance is provided to the Groups by NCI in order to help cover the costs involved in performing peer-reviewed and approved research-related activities. It is recognized that available funding in recent years has not been adequate to offset research costs completely. For clinical trials research, research costs include:
Applicants are instructed to develop their requested budgets, and the Initial Review Groups (peer reviewers) are instructed to recommend budgets, based on the FTEs required to accomplish the approved activities. The costs requested are inherently related to the implementation and maintenance of basic systems, the numbers of patients accrued, and the complexity of the study data being processed, but must also be related to the accuracy, quality and timeliness of the information collected. All budget requests must be fully justified. All new, competing continuation and competing supplemental (Types 1, 2 and 3) applications for support through the Clinical Trials Cooperative Group Program are submitted on Form PHS 398 (Rev. 5/95). These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/4350714; and from the Cancer Therapy Evaluation Program. The standard instructions included in the PHS 398 (Rev. 5/95) application kit are designed primarily for individual research projects, and do not address the unique goals and policies of this Program; this section supplements those instructions. It is strongly recommended that a letter of intent indicating the name of the Principal Investigator, Institution(s), Group and estimated cost be submitted six months in advance of the application submission deadline. A member institution which intends to apply or reapply out of cycle with the parent Group should submit a letter of intent as early as possible prior to the submission of the application. In cases where a new Group submits an application(s) or a member institution application will be in sequence with the competing continuation parent group, only the Group Chairperson need submit a letter of intent. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The Letter of Intent should be sent to: Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis Executive Plaza North, Room 741 Bethesda, MD 20892-7436 (301) 496-6056 EXPRESS MAIL ADDRESS: National Cancer Institute 6130 Executive Blvd. Room 741 Rockville, MD 20852FAX NUMBER: (301) 402-0557 The receipt dates and review schedule are as follows: Application Due Dates: Feb 1, Jun 1, Oct 1 Site Visit (if applicable): Apr/May, Aug/Sep, Dec/Jan Review Committee Meeting: Jun/Jul, Oct/Nov, Feb/Mar NCAB Meetings: Sep/Oct, Jan/Feb, May Earliest Possible Funding: Dec 1, Apr 1, Aug 1 Because of the interrelatedness of various components, all of the individual applications from a particular Cooperative Group should be submitted for review at the same time; similarly, funding recommendations for all of the components are usually of the same duration and time frame. Exceptions include competing supplement applications (see section VII.7), and applications from individual members submitted out-of-sequence with the remainder of the Group (see section VII.8); even in these cases, however, adjustments are made in the award such that funding periods coincide with those of the remainder of the Group. The guidelines which follow are based upon the operational model of a Cooperative Group described in Part VI, in which there are separate awards for the Headquarters, Statistical/Data Management Office, and individual Primary Group members. This structure is not required. Other models exist and may be more appropriate for some Groups. Nonetheless, this operational model describes the minimum essential elements for a successful Group, and the Group's aggregate application(s) should address these separate considerations regardless of actual Group structure. All applications, including that of the Headquarters/Operations Office, the Statistical and Data Management Center, and the Primary Members should describe the scientific and administrative experience of key personnel and should include and follow the PHS Form 398 instructions for Biographical Sketches and Other Support information (including support for clinical trials activities.) On page 2 of the PHS 398 (Rev. 5/95) form, in the section entitled KEY PERSONNEL, it is imperative that all applicants list all individuals and their institutions participating in the scientific execution of the project in the format as specified including those with no requested salary support. All applicants must ensure that the list is complete using as many continuation pages as necessary. VII.2. HEADQUARTERS (OPERATIONS OFFICE)
APPLICATION The essence of a Group's program of clinical trials should be
described in the application for support of its Headquarters. The
application should characterize the Group's mission, its plans to
accomplish that mission, and present the Group's research
accomplishments and its proposals for the upcoming project
period. It should outline the Group's strategy for each disease
or modality, including rationale and future plans; a clear sense
of direction should be evident. The Headquarters application
should also contain information describing the Group's
organizational structure, and the operating procedures and
policies to accomplish major Group objectives and
responsibilities. The following format is suggested for following items 1-4 of the "Research Plan" section of the standard form 398 instructions. a. Major Research Objectives - This section should concisely describe the Group's several major research objectives for the next funding period. This section should include plans for the inclusion of women and minorities as research subjects in Group studies. b. Group Organizational Structure - This should include a clear description of the formal organizational structure of the Group, including lines of authority and responsibility, with particular attention to the relationship of the organizational structure to the Group's major objectives. The organizational structure will usually include a number of disease, modality, and administrative committees, in addition to the three major functional components (Headquarters, Statistical/Data Management Office, and Member Institutions). The committees will have various research, quality control, and administrative mandates. Productive interaction of the organizational elements should be described and documented. The current members of the Group's executive committee should be named, along with their subspecialty affiliations. Procedures for the selection of Group leadership should be described. Procedures for credentialling members, for review of their performance, and for ranking member institutions in terms of contributions to the Group, should be described. c. Research Strategies - It is essential for the Group and its
research committees to develop and articulate comprehensive plans
which summarize the Group's specific objectives and lines of
investigation for each disease and modality chosen for study (see
Section IV.2). For each DISEASE COMMITTEE, the application should: 1) Briefly describe the major scientific accomplishments of the committee during the current project period (interval since last competing application.) 2) Identify all protocols (by protocol number) which were
active during the current project period, incorporating the
information follow. A suggested format is as follows: Year 1 Year 2 Year 3Etc. Initiated Accruing Patients Closed to Accrual Completed Analysis 3) Identify and discuss the major current research questions relevant to the purview of the committee. 4) Identify and discuss the Group's active and proposed studies in the context of these research questions. 5) Identify and describe problems experienced by the committee together with plans designed to address such problems during the next project period. 6) List the members of the committee. 7) Briefly discuss changes in the committee leadership during the current project period. 8) Provide a bibliography (by calendar year for the current project period) for each protocol. Include manuscripts submitted for publication (at the end of each protocol listing). 9) Provide a copy of each protocol active at the time of submission of the application. 10) Provide a copy of the concept sheets or draft protocols
for planned studies (including: statement of study objectives,
summary of rationale and pertinent background data, proposed
intervention(s) and preliminary statistical considerations). For each MODALITY COMMITTEE, provide a summary of that committee's scientific and administrative activities using a format such as that suggested in Attachment 1. d. Quality Control and On-site Auditing - This section should describe the Group's progress and plans for its programs of quality control (section V.2), and on-site auditing (section V.5). e. Group Accrual Statistics - Statistics regarding annual patient accrual, by protocol and institution, for the current project period, will be requested by the review committee prior to the site visit. A patient accession refers to a unique entry on study, not necessarily a patient new to the Group. In the case of entries onto Intergroup studies, the application of the coordinating Group should include data displayed for all participating Groups; applications of participating Groups should indicate their own accrual only. Numbers of patients in active follow-up should be indicated. See Attachment 2 (items 1 and 2) for a suggested format that will aid in the review of your application. f. Group Administration - This section should address the major roles and responsibilities of the Group administrative staff described in section VI.1, together with other matters of relevance to the management of the Group. It should document capable, efficient, and responsible management by the Group's leadership, as well as identifying problems and proposed solutions. Applications should clearly document that the proposed Group Chairperson is experienced in dealing with the problems of cooperative clinical cancer research and that s/he has appropriate experience to qualify him/her as the Group's leader. g. Accrual of Women and Minorities - Describe the composition of the proposed study population in terms of gender and racial/ethnic group. Include a description of proposed outreach programs for recruiting women and minorities as participants. h. Data and Safety Monitoring Committees - the application should describe the Group policies and procedures regarding DSMCs. It should include membership rosters of the committee(s), and procedures for avoiding conflicts of interest, such as financial disclosure procedures. i. Group Policies and Procedures - A copy of the Group Constitution and Bylaws, and a current copy of the Group Policies and Procedures, should be provided as an Appendix to the application. The application itself should specifically describe, in addition, Group policies regarding conflict of interest issues, the training of Group investigators, nurses and data managers/clinical research associates regarding ethics in the conduct of clinical research, and procedures in the event of scientific misconduct. The application should document ongoing ethics training of Group participants, collection of conflict of interest statements from relevant members, and other efforts to employ these policies. At the time of the award, the Grants Management Specialist may request an additional copy of the Group's Constitution and Bylaws, and a copy of the Group Policies and Procedures. j. Progress Report - A Progress Report is required for
competing continuation applications. The progress report may be
in the body of the application or submitted as an Appendix to the
application. The progress report should include a concise review
of the progress of each protocol active during the current
project period (accrual, amendments, toxicity, etc.) VII.2.B. Headquarters (Operations Office) Budget Since the organizational framework of each Group may be different, the headquarters budget should be presented in logical, discrete units, with specific budgets for each unit (e.g., Cooperative Group Outreach Program, Minority Accrual Initiative) as well as the total headquarters request. A specific budget page for the Group's quality control, study monitoring, and on-site audit programs and Independent Data and Safety Monitoring Committees must be included (see Section V). A separate budget page and item entitled "Developmental Fund" may be included. The purpose is to provide the Group leadership with resources to support new initiatives, special high-priority projects, and limited funding for candidate members. The first year's plans for this Developmental Fund must be carefully justified, and the Group's process for allocating the funds clearly described where relevant. Previous uses of the Fund should also be carefully described; it is a major factor in peer review assessment of subsequent requests. It is recommended that quality control services, and all research- and reference-laboratories of the Group, be funded via subcontract from, or consortium agreement with, either the headquarters or the statistical and data management office. (The exception to this policy is for quality control facilities providing services to the entire Cooperative Group Program which are funded under individual U10 awards for these purposes - e.g., the Radiological Physics Center). In this way responsibility for resource management rests most clearly and appropriately with the executive leadership of the Group utilizing the quality control services. The following budget guidelines apply specifically to the headquarters and statistical office budgets; the categories refer to the item entitled "Detailed Budget for Initial Budget Period" on (Form Page 4) of the PHS 398 (Rev. 5/95) grant application kit. a. Personnel - Precise justification for the amount of effort requested for each position is essential. 1) Scientific - research costs include the time and effort involved in developing the research agenda and repertoire of protocols for the Group, and analysis and publication of the results of Group research in peer reviewed journals in a timely manner. 2) Data Management - research costs include the time and effort involved in the central collection, computerization and analysis of primary patient data; determination of eligibility; registration and randomization; forms development; etc. 3) Laboratory investigations - research costs include the time and effort related to additional laboratory investigations specific to the research goals of the project, i.e., not associated with conventional patient care (note: some Cooperative Groups recommend these activities be allocated by NCI directly, through institutional U10 awards), 4) Administrative - research costs include the time and effort involved in the overall management of the Group's resources, compliance with regulatory activities, quality assurance and study monitoring procedures. b. Consultant costs - Reasonable consultant costs are allowed, if the consultant is contributing in a substantial way to the conduct or development of Group research. Most of a Group's consultant costs should appear in the Headquarters budget. Clear and quantifiable justification is required. These costs include travel, per diem and consultant fees, if applicable and within institutional policy. c. Equipment - Justification should include percent of time used for Group business as well as necessity for purchase. The amount of funds requested should be based on the percent of usage. Include only those equipment items that are required to conduct Group protocols. d. Supplies - Research costs include those related to communication and information dissemination among Group members. Quantitative justifications based on actual use should be provided. e. Travel - The importance of meetings to the accomplishments of any Group's research objectives is obvious, as is the necessity to maintain careful control of the size of this budget item. The budget for travel must be itemized and justified. It should include: 1) trips by the Group's leadership and investigators on behalf of the Group to the NCI and other national organizations where the results of the Group research must be represented or where Group research strategies are to be discussed; 2) travel for committee members to committee meetings held separately from the semi-annual Group meetings; 3) travel for protocol chairs and others who must perform quality control functions away from their home institution; 4) travel for persons on the Headquarters staff who must attend the Group's semi-annual meetings; 5) travel for the on-site audit program (Section V.4); and 6) a reasonable number of carefully justified trips for provisional or otherwise unfunded Group members to attend the semi-annual meetings in order to encourage participation and assure input from all relevant modalities is also allowable (see above regarding Developmental Fund). f. Patient care costs - See Section VII.4.B.e. g. Alterations and renovations - These costs are not allowable in the Cooperative Group Program. h. Other expenses - research costs include those related to communication and information dissemination among Group members. Include here costs of equipment rental and maintenance (copiers, telephones, computers), postage, copying and printing, etc., justified quantitatively on the basis of previous experience, where relevant. i. Consortium/contractual costs - research costs include support to Group members who are responsible for committees or laboratory investigations, for Group members whose institutions do not receive institutional U10 awards for the research costs related to approved clinical trials activities, or for patient accrual. For example, these allocations may be provided for the Cooperative Group Outreach Program, for the Minority Accrual Initiative Program, for the High Priority Trials Initiative Program and for otherwise unfunded performance sites. These third party costs may be presented as consortium arrangements (for substantive programmatic work), as subcontracts, or as reimbursements based on formulas. If third party costs are requested for consortium/contractual participants, a separate detailed budget page, with appropriate justification, must be provided for each arrangement. Indirect costs to consortium/contractual participants are included in the direct cost level for the Headquarters. Groups are encouraged to structure their organization in a manner which minimizes the burden of indirect costs on the overall Group budget. Reimbursement for patient accrual is to be based on formulas that must relate to the institution's membership category, scientific and leadership contributions, and prior performance including accrual and assessment of data accuracy and timeliness. A description of how the formula was determined, including a line item budget breakdown of the research costs, must be included in the application. In addition, the application must include a plan for disbursement of funds that includes consideration of performance and quality factors including eligibility and evaluability rates; data accuracy and completeness; and quality of onsite audits, etc. The funds received by Affiliates for patient accrual should be subject to modification based on results of the Group's performance reviews. These costs should be included in the consortium/contractual costs category of the Headquarters' budget. Consortium arrangements and all other contractual
arrangements, including all mechanisms for reimbursement for
patient accrual, must be formalized in writing in accordance with
applicable Public Health Service policy requirements (PHS Grants
Policy Statement, revised 9/94, page 817). A statement that the
applicant organization and the collaborating organization have
established or are prepared to establish a formalized agreement
that will ensure compliance with all pertinent Federal
regulations and policies must be included in the application.
Also include all pertinent biographical sketches and a list of
all other support for all relevant consortium participants. VII.2.C. SPECIAL APPLICATION REQUIREMENTS VII.2.C.1. 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 the Group's compliance with this requirement, each Group should conduct a comprehensive review of its current membership and provide in the 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. This table should follow the budget justification section of the application. In addition, please provide the following information related to the costs of conducting the audits: a. For the immediately preceding budget period, the actual total costs (direct and associated indirect) charged to the Headquarters or Statistical Center, as appropriate. b. For the current 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. c. For the upcoming budget period, the estimated total costs (direct and associated indirect) for conducting the planned audits. Please provide this information in the Budget justification section. The information may be provided in the format of the Group's choosing. No Group applications will be funded until all of the Group's
required audits are conducted and audit reports are received by
NCI. New Cooperative Groups should provide a projected accrual,
proposed audit dates and estimated audit costs for the upcoming
budget period. VII.2.C.2. Provision of Funds to Performance Sites for
Accruals 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: a. 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. b. 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. c. 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. VII.3. STATISTICAL/DATA MANAGEMENT OFFICE
APPLICATION In most Groups the Statistical and Data Management Office is
funded via a separate cooperative agreement. This arrangement is
encouraged by NCI. Occasionally, funding of a single Headquarters
cooperative agreement includes operations and statistics/data
management. In any event, the operational roles and
responsibilities discussed in Section
VI.2. should be addressed in a separate application or a
separate section of the Headquarters application. It should
describe in detail the Group's data management practices and
procedures, its quality control and study monitoring methodology,
and its analytical techniques and resources. VII.3.A. Research Plans The following format is suggested for following items 1-4 of the "Research Plan" section of PHS Form 398 (Rev 5/95) instructions. Wherever appropriate, narrative should supplement (rather than duplicate or replace) standard manuals, which should be supplied. 1. Roles and Responsibilities - list the major objectives of the Group's statistical and central data management staff. 2. Organization and Facilities - describe the organization and facilities to accomplish the complex tasks of central data management, quality control, study monitoring, and data analysis. 3. Data Management Policies and Practices - describe the flow of data following submission from the individual investigator. 4. Quality Control - describe procedures for quality control and accuracy verification. 5. Study Monitoring Procedures - describe the Group's standard methods for ongoing study monitoring, including interactions with study chairs. 6. Study Design and Data Analysis - describe the Group's routine methodologic practices (e.g., methods of sample size calculations, choice of testing and estimation procedures, interim analysis policies, early stopping procedures, etc.) Include plans for the inclusion of women and minorities as research subjects in Group studies (also required in Headquarters application). 7. Partnership in Group Research - describe the role and contributions of the Group's statisticians to Group research. The involvement of statisticians in designing studies should be documented. 8. Independent Research - describe research being conducted by the statistical office of the Cooperative Group using Group resources, including the data base. 9. Past Problems and Plans for the Future - Problems should be
frankly described, together with plans designed to address them
in the next funding period. VII.3.B. Statistical Office Budget Section VII.2.B. also applies to the Statistical/Data
Management Office budget requests. Request for computer systems
or other major equipment must be very carefully documented with
supporting justification and cost analysis. VII.4. PRIMARY/FULL/MAIN MEMBERS
APPLICATIONS Each primary member application should concentrate on the contributions of the institution to the Group. Specifically, applications should focus on the roles and responsibilities defined in Part VI.3.A. The clinical trials and research strategies of the Cooperative Group are described in the Headquarters application, and should not be repeated in the individual institution applications. Affiliate investigators associated with primary members must satisfy Group criteria for participation, and may request funds from only one source. Statistics on recent patient accrual, data quality and
scientific/administrative leadership will be obtained from the
Group Headquarters immediately prior to the peer review site
visit, in order to have uniformly collected and reported
information from all Group members. For a suggested format see
attachment 2, items 1 and 2. Accrual data regarding inclusion of
women and minorities as research subjects, however, must also be
reported in the institutional application(s). Specific assets of
the institution regarding access to particular patient
populations or unusual problems related to patient accrual should
be included in the application. The following format is suggested for following items 1-4 of the "Research Plan" section described in the standard form 398 instructions. Standardized reporting formats and time frames across the Group are strongly advised. Unless otherwise specified, contributions refer to the current project period, or in the case of new applications to the period of time since first affiliation with the Group. Updates will be requested from Group Headquarters immediately prior to the peer review site visit. For a suggested format see attachment 2, items 3-10. a. Summarize the institution's cancer research interest and capabilities. b. Describe the scientific contributions of the institution's investigators to the Group, focusing on their roles in shaping the Group's research strategies and in scientific committee leadership. Current committee membership should be listed. c. Describe the role of the institution's investigators in chairing or otherwise managing protocols currently accruing patients, identifying the investigators involved with the specific protocols. d. Describe institutional pilot studies preparatory to Group-wide studies and other clinical research contributions to the Group. e. Identify core services provided by the institution, such as laboratory studies or assays for particular protocols, service on site-visit teams or audits, etc. f. List all participants from the institution attending Group meetings (including committee and other special meetings) during the current project period. g. List authorship by the institution's investigators of Group publications, with separation of articles published, in press, and in preparation. h. Describe past and current participation by the institution's investigators in Group administrative committees (e.g., membership, audit, etc.) i. Describe institutional procedures for data management and data submission to the Group. Particular attention should be given to management of data from affiliates. j. Describe the organization employed for institutional Group participation. Document adequate participation from and interactions among all modalities and disciplines required for conduct of Group studies. Describe the process for determining intra-institutional protocol priorities. k. Describe problems with past institutional participation together with concrete plans designed to address such problems during the next project period. l. Accrual of Women and Minorities - Describe the composition of the proposed study population in terms of gender and racial/ethnic group. Include a description of proposed outreach programs for recruiting women and minorities as participants. m. Describe the existing affiliate network, if any,
identifying affiliated performance sites; describe institutional
procedures for processing affiliate data and auditing affiliate
charts, if relevant; describe communications systems between the
institution and its affiliates. VII.4.B. Budget Primary members perform two specific activities - they contribute scientific expertise to the Group, and they accrue patients to Group clinical trials. Institutional budgets should request those costs necessary for conduct of Group studies at the institution and for attendance of a reasonable number of investigators at regular Group meetings. The budget of a typical primary member institution is largely devoted to personnel, although variation from this norm is common. Each institution must develop its request based upon its unique requirements. The importance of meticulous justification for all budget items should be apparent. The Group Chairperson should provide each institution with guidance in the preparation of a reasonable request, in the development of a consistent format for budget presentation, and in the use of consistent formulas for institutional travel budgets. As indicated above, s/he will have been provided with guidance on the Group's aggregate budget by CTEP staff. Any specific fiscal or administrative questions should be addressed to the NCI Grants Management Specialist (Section IX.2). The following budget guidelines apply specifically to primary member institution applications; the categories refer to the items entitled "Detailed Budget for Initial Budget Period" on (Form Page 4) of the PHS 398 (Rev. 5/95) grant application kit. a. Personnel- Precise justification for the percent effort requested for each position is essential. 1) Data Management - research costs include the time and effort involved in accurate data collection and submission. 2) Other consultant costs (e.g., pathology, radiology). 3) Intellectual - research costs include the time and effort involved in developing the research agenda and repertoire of protocols for the Group, and preparing the results of the Group's research for publication. 4) Laboratory investigations - the time and effort related to additional laboratory investigations specific to the research goals of the project, i.e., not associated with conventional patient care (note: most Cooperative Groups fund these activities in the Group Operations Office cooperative agreements). 5) Administrative - research costs include the time and effort involved in coordinating research activities at the institution, compliance with regulatory activities, quality assurance and study monitoring procedures and participation in the Group on-site audit program. b. Consultant Costs- These are not usually appropriate in a primary member institution's budget. Requests should be justified in detail. These costs include travel, per diem and consultant fees, if applicable and within institutional policy. c. Supplies/Equipment/Other - Research costs include those associated with communication with the Group office and with affiliate institutions, the costs of compiling and mailing data and the costs of mailing or handling patient-related specimens, forms, and materials (e.g., slides, X-ray films). Significant equipment costs are unusual; all must be carefully justified. The amount of funds requested should be based on the percent of usage. d. Travel - Travel for a reasonable number of the institution's participating investigators, data managers and nurses to attend the regular Group meetings should be included in the institutional budgets. Attendance of investigators at meetings on behalf of the Group, or at special (i.e., non-routine) meetings of committees of the Group should generally be funded through the Headquarters or Statistical Office award, rather than the institution award. e. Patient Care Costs - Cooperative Group treatment trials always involve treatment which is administered with therapeutic intent to patients who require medical care, and always involves therapy which is either considered standard medical treatment, or can reasonably be expected to be superior to it. Therefore all costs associated with standard treatment are legitimately borne by third party carriers. Only in the most unusual circumstances would a Cooperative Group clinical trial require interventions beyond those considered state-of-the-art care for cancer patients. In those circumstances, a Group may make a case for reimbursement for patient care costs associated with the research element. The justification should be presented at the level of the Group headquarters application with specific request from each institution based upon likely accrual to the specific protocol. NCI will not support the costs associated with routine medical care. f. Consortium/Contractual Costs - Separate budget pages with detailed justification of all requested items should be submitted for each consortium agreement. Include applicable indirect costs. Consortium arrangements and all other contractual arrangements, including mechanisms for reimbursement for patient accrual, must be formalized in writing in accordance with applicable Public Health Service policy requirements (PHS Grants Policy Statement, Section 8-17). A statement that the applicant organization and the collaborating organization have established or are prepared to establish a formalized agreement that will ensure compliance with all pertinent Federal regulations and policies must be included in the application. Also include all pertinent biographical sketches and a list of all other support for all relevant consortium participants. VII.5. APPLICATION FOR NEW GROUPS An organization which chooses to apply to the NCI to establish a new Cooperative Group is strongly advised to consult with CTEP staff at the earliest stage of the planning process. CTEP staff then have maximum opportunity to advise the Group during the preparation of its application(s). While these Guidelines are written specifically for currently funded Cooperative Groups, the principles set forth should be followed in planning a new (first-time) competing application. VII.6. COMPETING CONTINUATION APPLICATIONS
Approximately 4 months in advance of the submission deadline for its competing continuation application(s), the Group Chairperson, Statistician and other executive leadership will be asked to meet with NCI staff to discuss the Group's future directions and plans in detail. While ongoing dialogue is an important feature of the cooperative agreement relationship, this meeting allows both the Group leadership and CTEP staff to focus attention on the application and review process and to discuss a realistic aggregate budget for the Group. Budget information discussed in this regard is, of course, advisory, but will be based on program staff's knowledge of the total clinical trials of the CTEP and the funds likely to be available for competing activities. The Group executive leadership should work with Group members in the preparation of a standard application format and individual component budgets, developing a total Group application package which, while requesting funds deemed necessary to support the proposed research, is organized and prioritized in accordance with CTEP's budget projections. VII.7 COMPETING SUPPLEMENT APPLICATIONS Potential applicants should consult with CTEP staff prior to the submission of a supplemental application. All applications for supplemental support must address a critical need which has developed since review of the basic application. Supplemental applications will not be reviewed if seeking restoration of funds for competing awards made at levels below that recommended by peer review. VII.8 APPLICATIONS OUT-OF-SEQUENCE WITH
THE PARENT'S GROUP CYCLE These applications are generally from new members of a Group
seeking funding for the first time, or are amended applications
from previously funded members who received priority scores too
low to allow funding at the time of the competing application of
the entire Group. Such applications should be submitted in the
same format as described in section VII.4., and will undergo peer
review using the same criteria as described in section VIII.3.C.
Although there is usually no site visit, a supporting evaluation
of the institution's performance as a Group member will be
obtained from the Group Chairperson by the Scientific Review
Administrator of the Clinical Groups Subcommittee. Applications
out-of-sequence with the parent Group's review and funding are
generally not encouraged. Should an award be made, it will be
phased in such that its budget periods and renewal date coincides
with those of the Group's. Potential applicants and the Group
Chairperson should consult with CTEP staff prior to the
submission of such applications. |
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