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CCSC: Steps After Proposal Approval

Obtaining Biospecimens and Clinical Data

Following proposal approval, the investigators must provide the following to the appropriate Network Group Bank in order for biospecimens and clinical data to be released:

  1. 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
  2. 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)
  3. Completion of the appropriate Material Transfer Agreement(s) (MTA) necessary for your receipt and use of these biospecimens
  4. Completion of the Data Use Agreement(s) (DUA) for receipt and use of 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.

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 email the NCTN-CCSC administrative team (NCINCTN-CCSC@mail.nih.gov). 

Unused Biospecimens

When I finish my specimen study, can I send any remaining samples or extracted nucleic acid back to the bank?

No. Specimens that are removed from the bank cannot be returned.

Can I isolate my own RNA or DNA or do I have to have the Bank do it?

The NCTN Group bank must do the isolations. Use of specific protocols can be negotiated with the bank. This is done to maximize availability and use of the samples, and to maintain quality control.

Responsibilities of CCSC Investigators

Progress Reports

CCSC investigators are required to submit regular progress reports to the NCI using the CCSC Progress Report Form. Progress reports should be submitted by email to the NCTN Navigator Front Door Service (navigatorcontact@imsweb.com).

Progress reports must be submitted:

  1. One year after CCSC proposal approval
  2. At study completion (final study report)
  3. At additional interims, for studies requiring more than one year to complete 

Publications

All correlative study results are expected to be published, including negative results.

Proof of submission of results for publication should take place no later than 1 year after completion of your study.

Publications should acknowledge, at a minimum:

  1. The NCI Network Groups who participated in the clinical trial(s)
  2. The grant numbers for the clinical trial(s)
  3. The grant number for the specimen bank(s)

Primary publications, including abstracts and manuscripts, must be emailed to the NCI (NCICTEPpubs@mail.nih.gov) prior to submission. You should allow time for NCI and collaborator review prior to submission. If your study included specimens from a trial conducted under a collaborative agreement, the collaborator must be given 30 days for comment before manuscript submission (5-7 days for abstracts).

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.

Data Sharing Policies

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. They are also subject to any applicable requirements of binding collaborative agreements.

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. This is because the clinical trials were conducted under the NCTN program. Requests for approval can be emailed (NCICTEPpubs@mail.nih.gov).

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
  • data sharing must comply with the terms of those agreements as explained in the Data Sharing Section of the Proposal Submission Form

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.

  • Updated:

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