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Clinical Trials Cooperative Group Program Guidelines, August 1996

X. TERMS AND CONDITIONS OF AWARD

A. Awardee Rights and Responsibilities
B. NCI Staff Responsibilities
C. Collaborative Responsibilities

A. AWARDEE RIGHTS AND RESPONSIBILITIES

The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES (Sections I-IX); the INVESTIGATOR'S HANDBOOK, (a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute); and the NCI­CTMB GUIDELINES FOR ON­SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES, and any subsequent modifications of these documents. Specific portions of these documents, as enumerated in the following sections, are incorporated by reference as terms of award. These documents are available from the Cancer Therapy Evaluation Program (CTEP) upon request.

Throughout these Terms and Conditions of Award "Participant" refers to all awardees as well as all institutions and/or individual investigators, both funded and unfunded, with whom they are participating or collaborating.

1. Development of Cooperative Group Research Agenda and Protocols: It is the responsibility of the Cooperative Group (henceforth termed the Group) in accordance with its constitution, bylaws, policies and procedures to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The Group shall, with CTEP assistance, develop Group research goals in accord with national research goals and develop protocols for clinical cancer research in accord with the Group's research interests, abilities and goals. The Group Chairperson shall designate other Group investigators to serve as Protocol Chairpersons for each proposed study. Protocols will be developed in accordance with the instructions in the CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES, and the INVESTIGATOR'S HANDBOOK. The INVESTIGATOR'S HANDBOOK is reference handbook for all investigators who use DCTD-sponsored investigational agents in their clinical trials, irrespective of funding mechanism. The INVESTIGATOR'S HANDBOOK describes, in accordance with NCI-FDA agreements:

  • Requirements for Protocol Development and Submission
  • Ordering Investigational Drugs from NCI
  • Responsibility for Reporting of Results to CTEP
  • Adverse Event Procedures
  • Accountability and Storage of Investigational Drugs
  • Monitoring and Quality Assurance

2. Coordination of Group Activities: In accordance with the Group constitution, bylaws, policies and procedures, the Group Headquarters (or Statistical/Data Management Office as appropriate), under the leadership of the Group Chairperson and with CTEP assistance, is responsible for coordinating protocol development, protocol submission, study conduct, quality control and study monitoring, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and Federally mandated regulations, and protocol and performance reporting. All the scientific and administrative decisions related to the Group funded activities and made by the participating institutions will be coordinated by the Group Chairperson with the assistance of the staffs of the Headquarters, Statistical Office, and/or Data Management Office. The Group Chairperson or designee will be responsible for communication with the appropriate CTEP staff.

3. Protocol Submission: Prior to protocol implementation, the Group Headquarters, under the leadership of the Group Chairperson, will submit the protocols for review to CTEP, or its designated Contractor, in accordance with the instructions in the NCI's INVESTIGATOR'S HANDBOOK and the CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES. It is required that all Phase III protocols be preceded by Concept Review letter describing the hypothesis to be investigated, the general design of the contemplated trial plus relevant information on accrual capabilities to document feasibility. A Letter of Intent (LOI) must be submitted for all Phase II trials that include a DCTD investigational agent. These two mechanisms for preliminary review are required to expedite protocol development and implementation and to facilitate agreement on study priority and design (see the INVESTIGATOR'S HANDBOOK, pp32­35, for further discussion of these mechanisms).

The Group Chairperson, with the assistance of the Group Headquarters' staff, will communicate the results of the NCI review of protocols to the participating institutions.

4. Group Compliance with Federally Mandated Regulatory Requirements: The Group must be in compliance with all Food and Drug Administration (FDA) regulatory requirements for studies involving investigational agents and NIH policies applying to the conduct of research involving human subjects. These regulations include but are not limited to Title 21 CFR 50,56 and 312 and Title 45 CFR 46. Participants are required to follow established Group procedures for complying with the Federally mandated regulations.

  1. The Group must be able to demonstrate that each participant has a current approved assurance number on file with the NIH Office for Protection from Research Risks (OPRR).
  2. The Group must be able to demonstrate that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, and that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch, (PMB), CTEP.
  3. The Group must be able to demonstrate that each patient (or legal representative) gives written informed consent prior to entry on study.
  4. The Group must assure timely reporting of all serious and unexpected toxicities to CTEP.
  5. The Group must establish and maintain an on-site audit program in compliance with the NCI­CTMB GUIDELINES FOR ON­SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES.
  6. The Group must have a method of providing, upon CTEP request, summary efficacy and toxicity data to be included in DCTD's annual report to the FDA for each investigational agent.
  7. The Group must implement the CTEP requirements for storage and accounting for investigational agents provided under DCTD sponsorship.

5. Investigational Drug Management: Investigators performing Group trials are expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. When new avenues of cancer therapy involving investigational drugs are pursued, the clinical information should be acceptable to the FDA for inclusion in a new drug application (NDA).

6. Quality Control and Study Monitoring:

a. The Group shall establish and implement mechanisms for quality control of therapeutic and diagnostic modalities employed in its trials. Participants are required to follow Group procedures for quality control. Quality control at a minimum should consist of:

  1. Pathology: Verification of pathologic diagnosis in cases where known variability in the accuracy of histologic diagnosis is a potentially serious problem and where pathology data may provide important prognostic information.
  2. Radiation Therapy: Review (either concurrent or retrospective) of port films and compliance with protocol­specified doses for individual patients. Determination of adequacy of radiation delivery with assistance of the Radiological Physics Center (RPC), whose functions usually include equipment dosimetry, periodic institutional visits and other aspects of physics review.
  3. Chemotherapy: Review of flow sheets with determination of protocol compliance in dose administration and dosage modification.
  4. Surgery: Assessment of adequacy of protocol­specified surgical procedures through review of operative notes and study­specific surgical forms.

b. The Group shall establish and implement mechanisms for study monitoring and quality assurance. Participants are required to follow Group procedures for study monitoring. The Group is responsible for assuring accurate and timely knowledge of the progress of each study through:

  1. tracking and reporting of patient accrual and adherence to defined accrual goals;
  2. ongoing assessment of case eligibility and evaluability;
  3. timely medical review and assessment of patient data;
  4. rapid reporting of treatment­related morbidity and measures to ensure communication of this information to all parties;
  5. interim evaluation and consideration of measures of outcome as consistent with patient safety and good clinical trials practice;
  6. timely communication of results of studies; and
  7. an on­site monitoring program.

The awardee is responsible for ensuring that all Main Members and Affiliates have routine audits in accordance with the NCI-CTMB GUIDELINES FOR ON­SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and that the results of audits are reported to the NCI in accordance with the guidelines. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients to the Group's protocols at the affected Main Member/Affiliate shall be suspended immediately upon notice of the NCI determination. The suspension will remain in effect until the awardee conducts the required audit and the audit report or remedial action is accepted by the NCI.

The awardee will be responsible for notifying any affected Main Member/Affiliate of the suspension. During the suspension period, no funds from this award may be provided to the Main Member/Affiliate for new accruals, and no charges to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution or at a third party institution supported under that institution's cooperative agreement.

c. Quality Assurance and Quality Control of Data

The awardee must follow NCI­approved procedures developed by the Group for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the Group. The awardee must follow Group procedures for the assurance of data quality and quality control in accordance with Group guidelines and NCI policies.

In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non­compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI­CTMB GUIDELINES FOR ON­SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES.

The awardee must follow policies developed by the Group and approved by the NCI for auditing the accuracy of scientific data submitted by Group participants.

7. Data Management and Analysis: The Group shall establish and implement mechanisms for data management and analysis that ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across Groups. Participants are required to follow Group procedures for data management and analysis.

8. Data and Safety Monitoring Committees: The Group must establish and maintain a Data and Safety Monitoring Committee (DSMC) for Phase III clinical trials. The policies and procedures of the DSMC must be approved by the NCI. The Group must comply with the approved policies and procedures of the DSMC.

9. Protocol Closure: The Group shall establish and implement mechanisms for interim monitoring of results and monitoring protocol progress. If the Group wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to implementation of the decision by the Group. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the protocol in order to facilitate these decisions. In the event that the DSMC has recommended early closure, DSMC procedures regarding notification of CTEP must be followed.

10. Protocol Reporting Requirements:

Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing study shall appear in the minutes of each Group meeting and shall include specific data on patient accrual as well as, when appropriate, detailed reports of treatment­associated morbidity. Quarterly accrual information must be provided by the Headquarters or Statistical Office as appropriate to NCI for all active studies. A system for providing such information in a timely manner should be in place. Participants must provide accrual data to the Group in accordance with Group procedures.

11. Adverse Event Procedures: In order to be in compliance with FDA regulations, all recipients of NCI support for clinical trials, including Groups responsible for coordinating and monitoring such trials, must promptly notify the NCI and any other sponsors of the trial of adverse events (i.e., adverse drug reactions) according to directions provided in the adverse event reporting section of the protocol.

The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/ investigators' responsibility to report adverse events as specified in the protocol.

The awardee will promptly notify the Investigational Drug Branch (IDB) Drug Monitor for DCTD-sponsored investigational agents and the NCI Program Director for other agents, of serious or life­threatening events, as instructed in the protocol.

12. Performance Review: The Group shall establish and follow policies and procedures for credentialling participating institutions and conducting periodic review of the performance and membership status of each Main Member/Affiliate. This review should examine scientific contributions, patient accrual, data accuracy and timeliness, protocol compliance, long­term patient follow­up and audit results. This mechanism will include a procedure for the Group Chair to recommend an adjustment of funds within the Group as appropriate for the level of participation in Group activities, including (but not limited to) accrual. This procedure can be either prospective (i.e., reimbursement by the case) or retrospective (financial adjustment at the time a non­competing continuation Type 5 award is made).

13. Procedures in the Event of Scientific Misconduct: If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work.

The awardee is also responsible, if the events described above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or patient safety, for submitting to NCI a reanalysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the reanalysis. The awardee must submit the reanalysis for publication. The NCI may disseminate information about the reanalysis as broadly as it deems necessary.

The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data.

True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to reanalyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee.

14. Data Files Available to NCI Upon Request: Upon the request of the Grants Management Officer, NCI, true copies of data files and supporting documentation for all NCI­supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner.

15. Notification of Patients by the Awardee During Patient's Lifetime: In order for there to be an appropriate response in the event the NCI determines, either while a protocol is active or (if relevant) during the lifetime of the subjects following protocol closure, that a medically important toxicity or side effect is associated with protocol­directed treatment or that the medical care of one or more subjects may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third­party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these subject(s') accrual, whether funded or unfunded, will have procedures in place to: (i) contact each subject individually at his or her last known address on file with the institution and which give each subject contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the subject has participated; and (ii) encourage subjects to notify the institution of any changes of address. The procedure must provide for informing the subjects fully of: the consequences of the toxicity or misconduct for their care and well­being, if any, and the availability of follow­up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or patient safety.

It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide subject names and treatments to the NCI in a format which allows direct notification of the patient by the NCI.

16. Progress Reporting: Annual progress reports will be submitted to the NCI in accordance with the instructions in the CLINICAL TRIALS COOPERATIVE GROUP PROGRAM GUIDELINES.

B. NCI STAFF RESPONSIBILITIES

The role of the Cancer Therapy Evaluation Program (CTEP) staff as described throughout these terms and conditions of award is to assist and facilitate but not to direct research activities. This cooperative agreement is part of a larger program of investigational agent development in the NCI. Each of the CTEP staff listed below has very specific and well defined responsibilities in terms of investigational agent development and the role of DCTD as a drug sponsor as defined in CFR 21 Part 312.

  1. Scientific Resource for NCI­Supported Clinical Investigations: The NCI Program Director, the Associate Director, CTEP (AD, CTEP), and staff of the Clinical Investigations Branch (CIB), the Investigational Drug Branch (IDB), the Biometric Research Branch (BRB), the Regulatory Affairs Branch (RAB), the Pharmaceutical Management Branch (PMB) and the Clinical Trials Monitoring Branch (CTMB) will serve as resources available to Cooperative Groups for specific scientific information with respect to treatment regimen, clinical trial design, investigational agent management and regulatory issues. The CIB Senior Investigator(s) designated by the NCI Program Director will assist the Group as appropriate in developing information concerning the scientific basis for specific trials and also will be responsible for advising the Group of the nature and results of relevant trials being carried out nationally or internationally. The CIB Senior Investigators and IDB Drug Monitors will also provide updated information on the efficacy and toxicity of investigational new agents supplied to Group members under an Investigational New Drug (IND) Application sponsored by the Division of Cancer Treatment and Diagnosis (DCTD). The CIB Senior Investigator will advise the Cooperative Groups of potential studies which will be relevant to new avenues of cancer therapy.
  2. Protocol Development: A protocol is the detailed written plan of a clinical experiment. The protocol must be mutually acceptable to the Group and to the CTEP Protocol Review Committee (PRC). Communication with CTEP staff at the various stages of protocol development is encouraged. The CIB Senior Investigator will assist the Group in protocol design as may be appropriate by providing information regarding: (a) the existence and nature of concurrent clinical trials in the area of research, pointing out possible duplication of effort, (b) information including relevant pharmacokinetic and pharmacodynamic data concerning investigational agents, and (c) availability of investigational agents, including biologic response modifiers. The CIB Senior Investigator will also comment on the scientific rationale and value of the proposed study, the design, the statistical requirements, and the implementation of the study, if indicated.
  3. CTEP staff will review and provide a Program response through the AD, CTEP, to Concepts for Phase III protocols and Letters of Intent for Phase II protocols, commenting on study originality and programmatic interest. These two mechanisms for preliminary review are required to expedite protocol development and implementation and to facilitate agreement on study priority and design (see the "INVESTIGATOR'S HANDBOOK," Section 5.6, for further discussion of these mechanisms).
  4. Review of Proposed Protocols: Group protocols will be reviewed by the CTEP Protocol Review Committee (PRC) which will meet weekly. It will be chaired by the AD, CTEP or his/her designee. Ad hoc reviewers, external to NCI, will be utilized when deemed appropriate by the committee chairperson. Formal protocol review and CTEP approval prior to activation are required for the following types of studies: (a) all protocols utilizing DCTD resources and investigational agents regardless of IND­sponsor; (b) all protocols that permit entry of one hundred or more patients; and (c) all phase III protocols. In addition, protocols requiring fewer than one hundred patients which utilize commercial agents only will receive full review. This includes BMT studies. However, approval will be based only upon consideration of safety and regulatory issues. Other protocols will be filed with CTEP for information purposes but will not require CTEP approval. Advisory reviews of such protocols may be provided to the Group at CTEP's discretion. For all protocols that require review, the AD, CTEP will provide the Group with a consensus review that describes recommended modifications and other suggestions, as appropriate (see the Investigator's Handbook," Sections 7.3 - 8.5, for further information regarding protocol review at CTEP).
  5. The major considerations relevant to Protocol Review by CTEP include: (a) the strength of the scientific rationale supporting the study, (b) the medical importance of the question being posed, (c) the avoidance of undesirable duplication with other ongoing studies, (d) the appropriateness of study design including interim monitoring plans, (e) a satisfactory projected accrual rate and follow­up period, (f) patient safety, (g) compliance with Federal regulatory requirements, (h) adequacy of data management, (i) appropriateness of patient selection, evaluation, assessment of toxicity, response to therapy and follow­up.
  6. If a proposed protocol is disapproved, the specific reasons will be communicated to the Group chairperson as a consensus review within 30 days of protocol receipt by the NCI. NCI will not provide investigational drugs or permit expenditure of NCI funds for a protocol that it has not approved. The CIB Senior Investigator will be available to assist the Group in developing a mutually acceptable protocol, consistent with the research interests, abilities and strategic plans of the Group and of the NCI.
  7. Review of Quality Control and Study Monitoring: The CTMB staff, will review and provide advice regarding mechanisms established by the Group for quality control of therapeutic and diagnostic modalities employed in its trials. The CTMB staff will review and approve the mechanisms established by the Group for study monitoring including the Group's on­site auditing program.
  8. CTEP and/or its contractor staff may attend, as observers, the on­site audits conducted by the Group. The frequency of participation by an NCI representative as observer will be determined by the NCI.
  9. Review of Data Management and Analysis: The BRB staff will review mechanisms established by the Group for data management and analysis. When deemed appropriate staff will make recommendations to ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across Groups. The NCI will have access to all data although they remain the property of the awardee institution. Data must also be available for external monitoring as required by NCI's agreement with the FDA relative to the NCI's responsibility as drug sponsor.
  10. Data and Safety Monitoring Committees: The NCI Program Director, assisted by the BRB staff will assess Group compliance with NCI established policies on Data and Safety Monitoring Committees (DSMCs) for Cooperative Group Phase III trials. One or more CTEP staff will serve as non­voting members on the DSMC.
  • Protocol Closure: The AD, CTEP, may request that a Phase I or Phase II protocol study be closed to accrual for reasons including: (a) insufficient accrual rate; (b) poor protocol performance; (c) patient safety; (d) study results are already conclusive; and (e) emergence of new information which diminishes the scientific importance of the study question.
  • NCI will not provide investigational agents or permit expenditures of NCI funds for a Phase I or Phase II study after requesting closure (except for patients on treatment and follow­up).
  • The AD, CTEP, may request that the Group DSMC consider closing a Phase III protocol to accrual for reasons including: (a) insufficient accrual rate; (b) poor protocol performance; (c) patient safety; (d) study results are already conclusive; and (e) emergence of new information which diminishes the scientific importance of the study question.
  • NCI will not provide investigational agents or permit expenditures of NCI funds for a Phase III protocol that has been closed (except for patients on treatment and follow­up).
  1. Involvement in Investigational Drug Management: The NCI will have the option to cross file or independently file an IND on investigational agents evaluated in trials supported under cooperative agreements. This would apply to drugs not developed in the NCI drug development program. The NCI Program Director, assisted by the RAB staff and the PMB staff will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the Food and Drug Administration (FDA) may mandate.
  2. Review of Compliance with Federally Mandated Regulatory Requirements: The CTMB staff and the RAB staff will review and provide advice regarding mechanisms established by the Group to meet Food and Drug Administration (FDA) regulatory requirements for studies involving DCTD­sponsored investigational agents and Office for Protection from Research Risks (OPRR) requirements for the protection of human subjects.
  3. CTEP Attendance at Cooperative Group Meetings: CTEP staff, as designated by the NCI Program Director, will attend the semi­annual Group meetings and will be invited as a non-voting observer to Group Executive Committee Meetings.
  4. Facilitate Completion Of Important Trials: CTEP staff will take an active role in promoting the timely completion of important studies, for example by encouraging and facilitating Intergroup collaboration when appropriate, or by assisting in the mobilization of other available and required resources.

C. COLLABORATIVE RESPONSIBILITIES

  1. Development of Intergroup Trials: The CIB Senior Investigators will conduct disease or modality oriented strategy meetings for the purpose of jointly developing the DCTD Clinical Trials Cooperative Group Program priorities for future protocol development. Group investigators, NCI staff and other extramural investigators will attend these meetings. The Groups and CTEP staff will work together to facilitate the timely development of protocols resulting from the consensus developed at such strategy meetings.
  2. Investigational Drug Development: When new avenues of cancer therapy involving investigational drugs are pursued, the clinical information should be acceptable to the FDA for inclusion in a New Drug Application (NDA). In collaboration with NCI staff, the Group will develop protocols to obtain such information as needed.
  3. Data Safety and Monitoring Committees: The appropriate conduct of the Group DSMC procedures are a collaborative responsibility of the Group and CTEP members.
  4. Cooperative Group Chairpersons' Semi­Annual Meetings: The Chairperson of each Cooperative Group, the NCI Program Director, the CIB Senior Staff, and other NCI personnel as indicated will meet semi­annually to discuss issues of relevance to the Clinical Trials Cooperative Group Program.
  5. Cooperative Group Statisticians' Meeting: Each Group's Chief Statistician, the NCI Program Director, the BRB staff, and other NCI personnel as indicated will meet together annually to discuss issues of relevance to the Clinical Trials Cooperative Group Program.

D. ARBITRATION

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel composed of one Group nominee, one NCI nominee, and a third member with clinical trials expertise chosen by the other two will be formed to review the CTEP decision and recommend an appropriate course of action to the Director, DCTD. The arbitration procedures in no way affect the awardee's right to appeal an adverse determination under the terms of 42 CFR Part 50, Subpart D, and 45 CFR Part 16. The Group will not expend NCI funds to conduct any study disapproved by CTEP unless CTEP's disapproval has been modified by the arbitration process outlined above.

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