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Biospecimen Access

NRG Oncology Biospecimen Access

The NRG Oncology Biospecimen Bank is the central repository and reference laboratory for biospecimens collected from patients enrolled in Phase II and III NRG Oncology clinical trials. This collection includes, but is not limited to: unstained slides, paraffin-embedded tissue blocks, frozen tissues, and biofluids such as blood, plasma, serum, and buffy coats. All biospecimens are from patients enrolled in NRG Oncology clinical trials and in the legacy Group trials of NSABP, RTOG, and GOG. Extensive clinical and outcome data exist for most of these biospecimens and are stored in the Statistical and Data Management Center.

The Biospecimen Bank provides annotated, de-identified, and, if required, anonymized biospecimens to qualified investigators who comply with National Cancer Institute (NCI) National Clinical Trials Network (NCTN) Banks access policies and who have funding to support their project (https://nctnbanks.cancer.gov/).  

Requesting NRG Oncology Biospecimens through NCI’s NCTN Navigator

Since the launch of NCI's NCTN Navigator on April 2, 2018, requests for biospecimens from many of NRG Oncology clinical trials must be submitted through Navigator. Please refer to the Navigator website (https://navigator.ctsu.org/) for additional details, a list of available trials, and/or to begin the biospecimen request process. The Navigator Front Door Service (navigatorcontact@imsweb.com) is available to address any further questions or concerns regarding Navigator.

All Other NRG Oncology Biospecimen Requests

For biospecimen requests from trials that are not available in the NCTN Navigator, please continue to use the following procedure (forms and processes are similar to those used in the Navigator access process):

1.) It is strongly recommended that investigators research the availability of biospecimens at https://nctnbanks.cancer.gov// and by directly contacting the NRG Oncology Biospecimen Bank prior to submitting the feasibility form. For questions about the process please contact BiospecimenAccess@NRGoncology.org.

2.) Complete the Feasibility Query Form and submit it to NRG Oncology at BiospecimenAccess@NRGoncology.org. Once received, NRG Oncology will assign a staff member to work with the investigator throughout the review process.

3.) The Feasibility Query will be reviewed by NRG Oncology staff. The investigator will be provided with a preliminary evaluation of the overall feasibility of the project including specimen availability and the appropriateness of the research question. 

4.) If the proposal is determined to be feasible, the investigator will be instructed to complete the NCTN CCSC Proposal Submission Form and submit it along with all letters of collaboration to BiospecimenAccess@NRGoncology.org. NRG Oncology will review the proposal, and upon approval, staff will work with the investigator, as appropriate, to refine the application prior to submission to the NCTN Core Correlative Science Committee (NCTN CCSC; 
https://ctep.cancer.gov/initiativesPrograms/nctn_ccsc_overview.htm) for review and approval.

5.) The NCTN-CCSC will review the application for scientific merit and alignment with the goals of the NCTN.  The NCTN-CCSC will provide written comments of their review.  

6.) If the application is approved by the NCTN-CCSC, the investigator will work with NRG Oncology staff to complete the regulatory and legal documentation needed prior to distribution of biospecimens. The documentation required includes:

      • Institutional Review Board (IRB)/Ethics Committee (EC) review/approval notification from the investigator’s institution 
      • Material Transfer Agreement (MTA) 
      • Funding commitment (There must be sufficient funds available to the investigator to cover the expenses related to the accession and distribution of biospecimens. The total cost with further details will be provided by the NRG Oncology Biospecimen Bank on inquiry from the investigator.)
      • Data Transfer Agreement (DTA), if appropriate, for the transfer of clinical data

7.) Investigators are required to notify NRG Oncology of any publications that result from the use of biospecimens.

For questions regarding this process, please contact BiospecimenAccess@NRGoncology.org.


Biospecimen Collection, Processing, and Shipping Inquiries

Nurses and CRAs with questions about biospecimen collection, processing, and shipping should refer to the following webpage for additional information: https://www.nrgoncology.org/Nurses-CRAs/Biospecimen-Bank.



Copyright 2018 by NRG Oncology