Proposal Submission and Instructions

Proposal submission

Proposals requesting samples from clinical trials of the NCTN Network Groups submitted via the NCTN Navigator Clinical Trials Specimen Resource will be considered for review.

For more information about the specimens inventoried in Navigator and the query, LOI, and proposal submission process, visit the Navigator website and read the FAQs: https://navigator.ctsu.org/.

Proposals for use of biospecimens from NCT Network Group Phase 2 clinical trials should be submitted directly to the CTEP PIO.

All submission formats require that the proposal PI be a CTEP-registered investigator.

Detailed instructions for investigators for proposal submission, review, and post-approval

STEP 1: Proposal submission

• To submit a proposal through Navigator, you must have submitted an LOI and received a Report that the request is feasible. If you receive a report that the request is not feasible, you will need to revise your approach and submit a new LOI.
• If the FDS Report indicates feasibility, you may fill out and submit a full proposal for NCTN Core Correlative Science Committee (CCSC) review. This is done using the Proposal Submission Form, which also is available through Navigator.
• Note: Each section of the Proposal Submission Form includes prompts for critical information, such as the sample, assay, and statistical specifications that are required. Incomplete proposals may be returned and/or administratively disapproved.
• Each proposed marker/analyte must be supported by background data for the proposed hypothesis(es) and by evidence that the proposed biomarker assay(s) works in the targeted biospecimen type with appropriate quality control and quality assurance.
• Letters of Collaboration, including from the primary statistician, must be obtained and provided with the study proposal in a single pdf upload document.
• After proposal submission, Navigator will forward the proposal for quality assurance review and subsequent assignment to the NCTN-CCSC.
• All inquiries into the status of your proposal should be addressed to the Front Door Service (FDS) at navigatorcontact@imsweb.com.
• Proposals are accepted through Navigator on a rolling basis. Proposals received and accepted by PIO ≥6 weeks prior to the standing CCSC review date will be scheduled for the call 6 weeks hence, pending review slot availability. If the Committee agenda is full, it will be queued to the next available review slot.

STEP 2: Proposal review

• Proposals will be reviewed by the NCTN-CCSC for scientific merit, feasibility, and appropriateness of the statistical plan. Proposals may be approved, approved-on-hold (explained below), receive revisions requiring a response, disapproved, or not forwarded to Committee. Proposals not forwarded to Committee are administratively disapproved by CTEP. Reasons for such disapproval may include lack of sufficient information to analyze the science, feasibility, and/or statistical plan, inappropriate use of samples (see Overview and Expanded Evaluation Guidelines sections). If/when resubmitted, such proposals will be entertained as de novo submissions.
• As of January 1, 2019, there are two Core Correlative Science Committees, A and B. CCSC-A will focus predominantly on adult solid tumors, with overflow going to CCSC-B. CCSC-B will be tasked with review of proposals using biospecimens from sarcomas, hematologic malignancies, and from AYA and pediatric cancer trials.
• Proposals that are disapproved may only be resubmitted at a later date, as a new proposal, should new and compelling data and/or supportive information arise.
• Notification of the decision on your proposal is anticipated to be forwarded from CTEP PIO to you, via Navigator, within 2 weeks of Committee proposal review.

• Any correlative science proposal requesting biospecimens from a clinical trial conducted under a binding clinical collaborative agreement between CTEP and a Collaborator will be subject to review and comment by the Collaborator (for example, by the company that provided the drug) prior to final CTEP approval. These proposals, if approved by the NCTN-CCSC, will therefore receive an approval-on-hold and will be forwarded to the Collaborator for comment, due within approximately 2 weeks.  Final CTEP approval will be given after NCTN-CCSC and Collaborator comments have been addressed.

  Note: Proposals from other investigators may be under review or approved during the time of your proposal development and review. These other proposals may, if approved and funded, lead to biospecimen release that may reduce the biospecimen inventory available for release to your proposal. Biospecimens are not allocated to your proposal until it receives full approval.

STEP 3: Obtaining the biospecimens and clinical data

You must provide the following to the appropriate Network Group Bank, before biospecimens or data for approved proposals can be released to you:

• Documentation of funding to cover:
  • NCTN Network Group biospecimen processing and shipping fees
  • NCTN Network Group data collection and processing fees
  • Execution of scientific study according to the approved proposal, including the laboratory resources needed
• Demonstration of IRB or Ethics Committee approval to receive and study anonymized, linked biospecimens (i.e., approval from your local IRB, as well as the local IRB of any collaborating investigator who will be receiving biospecimens).
• Completion of the appropriate harmonized Material Transfer Agreement(s) (MTA) necessary for your receipt and use of these biospecimens, and Data Use Agreement(s) (DUA) for receipt and use of the clinical data.

The above documentation must be received within 12 months of the date of the approval letter. If funding is still pending, the principal investigator may submit a request for an extension via the progress report (see Step 4). If funding documentation is not received within 12 months, the biospecimens may be released back to inventory and you will have to reapply for the biospecimens. If there are any other issues, please contact the NCTN-CCSC administrative team at NCINCTN-CCSC@mail.nih.gov.

STEP 4: Responsibilities of investigators with approved studies

• A progress report at one year post-proposal approval and at study completion (final study report) must be submitted to the National Cancer Institute (NCI) via the NCTN Navigator Front Door Service at navigatorcontact@imsweb.com, using the Progress Report Form. If the study will take more than one year to complete, additional interim progress reports may be required.

• Primary publications (abstracts, manuscripts) must be submitted to the NCI at NCICTEPpubs@mail.nih.gov, and should include appropriate acknowledgments — e.g., of the Network Groups who participated in the clinical trial(s), and the grant numbers for the clinical trial(s) and specimen bank(s).

  Please note: If at least one of the trial(s) from which your study used specimens was conducted under a collaborative agreement, the Collaborator (for example, the company that supplied the drug) will be given a 30-day comments period for manuscripts prior to manuscript submission and a 5 to 7 day comments period prior to abstract submission. Therefore, in these cases, manuscripts and abstracts resulting from your study must be sent to NCI at NCICTEPpubs@mail.nih.gov within a timeframe that would accommodate both these timelines and your submission deadline. In your email, please indicate that you are attaching the manuscript/abstract for pre-submission review by the Collaborator, and list the trial(s) from which your study used specimens.

  Please note: It is expected that all results are published, including negative results. Proof of submission of results for publication should take place no later than 1 year after completion of your study.

• Follow-through on data-sharing and public access responsibilities as delineated in your approved proposal is expected. Research projects using biospecimens from NCTN clinical trials are subject to the requirements in NIH policies for data sharing and public access to publications, listed below, and to any applicable requirements of binding collaborative agreements.

  Final NIH Statement on Sharing Research Data
  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
  http://grants.nih.gov/grants/policy/data_sharing/

  NIH Genomic Data Sharing Policy
  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html
  http://gds.nih.gov/

  Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research
  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html
  http://publicaccess.nih.gov/index.htm

  If the biospecimens are from a trial that was conducted under a binding collaborative agreement with NCI or a pharmaceutical company (for example, with a company that supplied the drug), data sharing may have to await the timelines stipulated in those agreements and must be in compliance with the terms of those agreements as explained in the Data Sharing Section of the Proposal Submission Form.

  Any data related to your approved project cannot be submitted to any public or controlled access database (after your data are published) without NCI written approval from the DCTD/CTEP NCTN Program Director since the clinical trials were conducted under the NCTN program. Requests for approval can be sent to NCICTEPpubs@mail.nih.gov.

  If the trial(s) from which specimens are requested were conducted under a NCI/CTEP IND and/or CTEP Collaborative Agreement, your correlative research is subject to the terms of the CTEP IP Option as well as the terms of the CTEP Collaborative Agreement. Similarly, studies requesting specimens from trials conducted under a NCTN Group or Company IND will also be subject to the terms of the agreement between the Collaborators. Any discoveries from research performed on such specimens will be subject to the CTEP IP Option and/or the licensing terms as required by these agreements.