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Clinical Trials Cooperative Group Program Guidelines, August 1996VI. GENERAL OPERATIONAL CONSIDERATIONS VI.1. Headquarters VI. GENERAL OPERATIONAL CONSIDERATIONS
Each Cooperative Group consists of three major operational components: the headquarters (including the Group Chairperson's office), the central statistical/data management office, and the participating investigators and institutions. Each component has general responsibilities in meeting the goals and objective outlined in Parts II-V of these Guidelines, or in completing tasks necessary to accomplish those goals. Each Group is governed by a constitution and bylaws, which describes membership criteria, procedures for selecting Group leadership and other details of governance, and is led by a chairperson who is ultimately responsible for the content and conduct of the Group's research program. Beyond this requirement, the structure and management of the individual Group is the responsibility of the Group itself to determine. The following sections describe the responsibilities and functions of each of the three operational components. The Headquarters is the direct responsibility of the Group Chairperson. It provides executive leadership and day-to-day administrative management of the Group. Through this office the Chairperson implements the Group's scientific and organizational policies. Specific roles and responsibilities include the following:
VI. 2. STATISTICAL/DATA MANAGEMENT OFFICE
A Group's statistical and data management staff are integral collaborators in all stages of study development, conduct, analysis and reporting. The general operational responsibilities usually assumed by this component include: 1. Ensuring study feasibility and appropriateness of study design with respect to stated study objectives. 2. Ensuring that there are clear and consistent definitions of study objectives, eligibility criteria, primary analysis endpoints, evaluation criteria (such as toxicity and response definitions) and guidelines for removal of patients from protocol therapy. 3. Developing non-standard designs when necessary to achieve specific study objectives. 4. Implementing plans for interim monitoring of study data, including planned interim analyses of studies and timely reporting to the DSMC of all toxicities. Interim study reports should be prepared according to Group policies in this regard. In general, reports of accrual, eligibility, evaluability, and toxicity should be made for each open study on at least a semiannual basis.. 5. Implementing appropriate registration, randomization procedures and accrual tracking procedures. 6. Designing, developing and implementing forms required to collect Group study data. 7. Providing for all aspects of the collection and management of Group study data. 8. Participating in the establishment and conduct of quality control (see V.2) and study monitoring (section V.3) procedures. The Statistical Office may coordinate the Group's on-site monitoring program. 9. Preparing interim study reports according to Group policies in this regard. In general, reports of accrual, eligibility, evaluability, and toxicity should be made for each open study on at least a semi-annual basis. 10. Contributing to all decisions regarding the conduct of Group studies. 11. Performing statistical analyses that use state-of-the art methodology and provide unbiased results. 12. Co-authoring articles and abstracts based on protocol results and other Group data where appropriate; publishing on methodologic issues in cancer clinical trials. VI.3 PARTICIPATING INVESTIGATORS/MEMBERSHIP CATEGORIES Investigators participating in Cooperative Group research may come from a wide variety of academic and practice settings. Recognizing current realities of oncologic practice, the NCI provides various mechanisms of financial support for motivated investigators, including the Primary Member cooperative agreement (for members and their affiliates supported directly by NCI's DCTD), the Community Clinical Oncology Program (CCOP) cooperative agreement (for members supported directly by NCI's DCPC), and third-party payments (subcontracts or purchased service agreements) for member institutions that do not hold cooperative agreement awards, Cooperative Group Outreach Program (CGOP) institutions and/or other performance sites. Individual Cooperative Groups use some or all of these mechanisms. Participating investigators may receive additional headquarters office funds for the conduct of administrative, scientific, laboratory or high priority tasks which are within the workscope of the Group. The Group shall establish policies and procedures for
credentialling participating institutions and conducting periodic
review of the performance and membership status of each
performance site. This review should examine scientific and
administrative contributions, patient accrual, data accuracy and
timeliness, protocol compliance, and audit results. Primary/Full/Main member institutions are, for the most part, academic centers. In addition to patient accrual, substantial importance is placed on scientific and administrative contributions to the Group. Each Group establishes its own specific criteria for membership and a formal process for application. Institutions are generally initially admitted for membership on a provisional basis. Eligibility for institutional cooperative agreement awards is limited to institutions which have been granted full membership by the Group, and continued NCI funding is contingent upon maintenance of satisfactory membership status, progress and accrual by the institution and the Group as a whole. Investigators at primary member institutions are expected to: 1. Actively participate in the Group's scientific committees. 2. Serve as Study Chairs responsible for the development and conduct of specific Group studies. 3. Contribute their independent laboratory and clinical research experience to the Group. 4. Actively participate in Group meetings. 5. Accrue patients to Group protocols. 6. Submit timely and accurate patient data to the statistical office. 7. Author manuscripts and abstracts to disseminate the results of Group studies. 8. Participate in the Group's on-site audit program. 9. Serve on Group administrative committees. 10. Periodically serve on NCI site visit teams and peer review committees. 11. Develop community outreach programs that involve patients and patient advocates in the Group's research in a productive and meaningful manner. This effort should be coordinated with the Headquarters/Operations Office. 12. Foster and monitor accrual of women and racial/ethnic minorities to Group trials. 13. Assume responsibility for all Group activities conducted
at his/her own institution and at that institution's
affiliate/satellite locations. An affiliate or satellite member
of a Group is usually a physician or group of physicians which
enters patients on the Group's protocols through a member
institution. Specific criteria for affiliate membership are the
responsibility of the Group, but must be in accordance with NCI
policies as specified in the Investigator's Handbook, Section 13.
On-site auditing of affiliates must be in accordance with CTMB
guidelines. (See Section V.5.D.)
VI.3.B. Affiliate Members Affiliate Members are proposed by primary member institutions
and represent sites of scientific or clinical expertise that are
judged by the primary member institution to contribute
significantly to the quality of that institution's programs.
Minimum standards for accrual should be established by the Group
for affiliate participation. All nominations for affiliate status
should be reviewed by the Group Membership Committee and endorsed
by the process established by the Group. Affiliates must comply
with all OPRR, NCI and Group policies prior to participation. VI.3.C. Cooperative Group Outreach Program Participants The Cooperative Group Outreach Program (CGOP) was established
in 1977 to involve community physicians, hospitals and their
patients in clinical cancer research. The Program supports
community investigator networks through funds provided by the
Division of Cancer Treatment and Diagnosis to a Cooperative Group
headquarters or statistical center. CGOP investigators affiliate
with a funded Cooperative Group, generally through a primary
member. They submit data in the same format and according to the
same standards as any other member or affiliate investigator.
Quality control is assured by the usual Group monitoring and
evaluation procedures. VI.3.D. High Priority Trials Initiative Participants The High Priority Trials Initiative was implemented by NCI in
order to increase accrual to designated studies selected by the
Cooperative Group Chairpersons and endorsed by the Board of
Scientific Counselors, DCTD. The Office of Cancer Communications,
NCI promotes the designated trials, and clinical trials research
in general, through Public Relations activities designed to
educate physicians and the public regarding opportunities to
participate in clinical trials research. High Priority Trials
investigators affiliate with the Cooperative Group through the
Operations Office. They submit data in the same format and
according to the same standards as any other member or affiliate
investigator. Quality control is assured by the usual Group
monitoring and evaluation procedures. VI.3.E. Minority Accrual Initiative Program Participants The Minority Accrual Initiative was conceived in 1990 in an
effort to increase the accrual of racial/ethnic minority patients
onto Group clinical trials and to investigate the basis for
observed differences in cancer outcome among racial/ethnic
groups. Activities supported through this program include
reimbursement of performance sites for increases in accrual of
minority patients over previously established baselines;
translation of patient education materials into languages other
than English; training for investigators to enhance skills for
recruiting minority patients; and the recruitment of translators
and patient advocates to help with accrual and follow-up of
minority patients. These efforts are supported by funds provided
to the Operations Office; performance sites submit data in the
same format and according to the same standards as any other
member or affiliate investigator. VI.3.F. Community Clinical Oncology Program (CCOP) Participants CCOP participants are funded by the Division of Cancer
Prevention and Control (DCPC). They are community-based
organizations which participate in Cooperative Group treatment
protocols and cancer prevention and control research studies
based in Cooperative Groups or in cancer centers. DCPC
periodically publishes a Request for Applications (RFA) for CCOP
funds in which the application process, eligibility and funding
criteria are described. CCOP participants affiliated with a
Cooperative Group have access to Group protocols approved by the
Group and by NCI for CCOP accrual, and submit data in the same
format and according to the same standards as any other member or
affiliate investigator. Group operations/statistics offices are
funded by DCPC through separate research base awards to support
the additional administrative responsibilities for and analysis
of the data supplied by CCOP members. Duplicative funds should
not be requested in applications to be funded by DCTD, nor may
funds awarded to the Groups be rebudgeted for accruals. |
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