NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers counterproductive since fewer children would be available for the pediatric Network study if other studies were required to recruit and include children. 1.5.6 Data and Safety Monitoring Policy and Plans The Network Group Operations Center must establish a Data and Safety Monitoring Policy for the clinical trials conducted by the Group in compliance with NIH and NCI guidelines for data and safety monitoring for clinical trials. Data and Safety Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs) must be established that comply with the “NCI NCTN Program Data Monitoring Committee Policy” as provided in Part 4 – Appendices – Section VIII. For the purposes of these Guidelines, the terms DSMB and DMC are used interchangeably to refer to committees established under with this policy. The DSMB/DMC must be used to monitor all phase 3 trials and randomized phase 2 trials led by the Network Group. The Network Group’s DSMB/DMC policy and membership roster, as well as any changes/modifications to the policy or membership roster, must be submitted to and approved by the Lead NCTN Program Director. Monitoring Plans for Trials Not Under DSMB/DMC: Data and Safety Monitoring plans developed for other Network Group studies (e.g., phase 1 and phase 2 studies, pilot studies, etc.) must comply with the NIH policy for data and safety monitoring, posted on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/not98-084.html, with additional description at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Further information concerning essential elements of Data and Safety Monitoring Plans for clinical trials funded by the NCI is available at: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines. 1.5.7 Resource Sharing Plans Data Sharing Policy: The Network Group Operations Center is required to have a plan for sharing research data. Information on the NIH policy regarding sharing research data can be found on the NIH website at: http://grants.nih.gov/grants/policy/data_sharing. The Network Group Operations Center’s policy for data sharing must be submitted to and approved by the Lead NCTN Program Director. A template to help Network Group Operations Centers develop their own Data Sharing Policies is provided in Part 4 – Section VII of these Guidelines. Per this policy, requests for data will only be considered once the primary study analyses have been published. Requests for data from clinical trials, conducted under a binding collaborative agreement between NCI/DCTD and a pharmaceutical/biotechnology company, that are not under DSMB monitoring but are not yet subject to the Data Sharing Policy (e.g., because the primary study analyses have not yet been published) must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD (i.e., the Lead NCTN Program Director in conjunction with the NCI/DCTD Regulatory Affairs Branch). Release of data may also be subject to the terms of any contracts the Network Group Operations Center has with other entities which cover any of the requested data. Biospecimen Sharing Policy: The Network Group Operations Center is required to follow the NCI/DCTD policy regarding review of requests for use of banked biospecimens collected in association with NCTN trials that it leads by CTEP’s Protocol Review Committee or an NCI/DCTDapproved NCTN Correlative Science Committee as described in Part 1 – Section IV.C.3. Network Group Operations Centers are also required to have a plan/policy in place to describe how information on its inventory of biospecimens will be made available to the public that is submitted to and approved by the Lead NCTN Program Director, Associate Director Cancer Diagnosis Program, and Program Director of the Tumor Banking Program for the Network Groups. This inventory should be consistent with standards established by the Network Tumor Banking Committee for the NCTN Program. Page 52 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers Network Group Operations Centers should also have plans in place regarding the following types of resources, as appropriate for the clinical research it conducts: Sharing Model Organisms and Genome Wide Association Studies (GWAS). 1.5.8 Education on the Protection of Human Subjects NIH policy requires education on the protection of human subject for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. This policy is available on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 1.5.9 Other Federal Regulations Information on other federal regulations (and their associated citations/URLs) that may be applicable to the Network Group Operations Center’s research is provided in Part 4: Appendices – Section IV.B. 1.6 Conflict of Interest Policy The Network Group Operations Center receiving NIH funding from a grant or cooperative agreement must establish a Conflict of Interest Policy that is in compliance with all of the DHSS regulatory requirements for conflict of interest as outlined by NIH grants policy available at: http://grants.nih.gov/grants/policy/coi. This policy should ensure that there is no reasonable expectation that any investigator or staff member of the Network Group Operations Center or at any of its member institutions/sites involved in the design, conduct, or reporting of research will be biased by any conflict of interest (using the definition of investigator provided in the NIH grants policy). This policy should also be in compliance with NCI/DCTD/CTEP’s Conflict of Interest Policy for NCTN Phase 3 Clinical Trials found on the CTEP website at: http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies. 1.7 Special Requests for Use of the NCTN Program Infrastructure Services The infrastructure of the NCTN Program, including NCI/DCTD supported contract services, can only be used for NCTN trials approved by NCI/DCTD under this Cooperative Agreement. In special circumstances, a Network Group Operations Center may request limited use of certain services (e.g., regulatory support services (RSS), the Oncology Patient Enrollment Network (OPEN) for a related research effort or study such as a banking protocol not associated with a specific NCTN clinical trial that is supported by charitable funds or a related oncology research study funded by another NIH-funded program). These requests must be reviewed and approved by NCI/DCTD via an official written approval by the Lead NCTN Program Director and the Associate Director, CTEP. It is anticipated that only requests that are compatible with and are anticipated to benefit the overall research goals of the NCTN Program would be approved, subject to the availability of NCTN Program resources/funding, since the use of the requested services are funded under the NCTN Program. Page 53 of 241
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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section IV – Terms/Conditions of Award – <strong>Network</strong> Group Ops Centers<br />
<strong>Network</strong> Group Operations Centers should also have plans in place regarding the following types<br />
of resources, as appropriate for the clinical research it conducts: Sharing Model Organisms and<br />
Genome Wide Association Studies (GWAS).<br />
1.5.8 Education on the Protection of Human Subjects<br />
NIH policy requires education on the protection of human subject for all investigators submitting<br />
NIH applications for research involving human subjects and individuals designated as key<br />
personnel. This policy is available on the NIH website at:<br />
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.<br />
1.5.9 Other Federal Regulations<br />
Information on other federal regulations (and their associated citations/URLs) that may be<br />
applicable to the <strong>Network</strong> Group Operations Center’s research is provided in Part 4: Appendices<br />
– Section IV.B.<br />
1.6 Conflict of Interest Policy<br />
The <strong>Network</strong> Group Operations Center receiving NIH funding from a grant or cooperative agreement<br />
must establish a Conflict of Interest Policy that is in compliance with all of the DHSS regulatory<br />
requirements for conflict of interest as outlined by NIH grants policy available at:<br />
http://grants.nih.gov/grants/policy/coi. This policy should ensure that there is no reasonable<br />
expectation that any investigator or staff member of the <strong>Network</strong> Group Operations Center or at any of<br />
its member institutions/sites involved in the design, conduct, or reporting of research will be biased by<br />
any conflict of interest (using the definition of investigator provided in the NIH grants policy). This<br />
policy should also be in compliance with <strong>NCI</strong>/DCTD/CTEP’s Conflict of Interest Policy for <strong>NCTN</strong> Phase 3<br />
<strong>Clinical</strong> <strong>Trials</strong> found on the CTEP website at:<br />
http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies.<br />
1.7 Special Requests for Use of the <strong>NCTN</strong> <strong>Program</strong> Infrastructure Services<br />
The infrastructure of the <strong>NCTN</strong> <strong>Program</strong>, including <strong>NCI</strong>/DCTD supported contract services, can only be<br />
used for <strong>NCTN</strong> trials approved by <strong>NCI</strong>/DCTD under this Cooperative Agreement. In special<br />
circumstances, a <strong>Network</strong> Group Operations Center may request limited use of certain services (e.g.,<br />
regulatory support services (RSS), the Oncology Patient Enrollment <strong>Network</strong> (OPEN) for a related<br />
research effort or study such as a banking protocol not associated with a specific <strong>NCTN</strong> clinical trial that<br />
is supported by charitable funds or a related oncology research study funded by another NIH-funded<br />
program). These requests must be reviewed and approved by <strong>NCI</strong>/DCTD via an official written approval<br />
by the Lead <strong>NCTN</strong> <strong>Program</strong> Director and the Associate Director, CTEP. It is anticipated that only<br />
requests that are compatible with and are anticipated to benefit the overall research goals of the <strong>NCTN</strong><br />
<strong>Program</strong> would be approved, subject to the availability of <strong>NCTN</strong> <strong>Program</strong> resources/funding, since the<br />
use of the requested services are funded under the <strong>NCTN</strong> <strong>Program</strong>.<br />
Page 53 of 241
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