NCI and the NCI Community Oncology Research Network (NCORP) developed the Landscape survey primarily to inform CCDR trial design and to aid in targeted site recruitment for study/trial participation. Stakeholders witnessed an increase in requests to access and utilize the landscape data for publication, independent of NCORP trial development. Consequently, NCI created an approval process for data requests with the goal of publication. First, investigators must request approval by their affiliated NCORP Research Base (RB).Per NCI, RB Statistics and Data Management Center (SDMC) are solely responsible for the landscape survey data and cannot disseminate any data. Consequently, the RB SDMC will perform all data analyses within the respective research base infrastructure. This document outlines NRG Oncology’s NCORP approval process to access landscape survey data for potential publication. Please note that this process is only if the landscape survey data will be published. The table below outlines the scenarios when an application must be submitted for approval.
| Concept development / Trial design
|
Publication
|
Approval of landscape survey access application required
|
| Yes
|
Yes
|
Yes
|
| Yes
|
No
|
No
|
| No
|
Yes
|
Yes
|
- Investigators must complete an application outlining the objectives, study rationale, and survey items requiring analysis. Investigators must submit this request to NRG’s NCORP Administrator, Erica Field (fielde@nrgoncology.org). Note:
Investigators must be affiliated with an NCORP site or a member of an NRG NCORP
committee.
- NRG Oncology CCDR chair and vice-chair, and the Deputy Director of NRG NCORP SDMC will review each request.
- The NRG NCORP Administrator will notify investigators of NRG’s decision via e-mail within 8 weeks of submission.
- Any approved project requires the investigator to subsequently submit their request for the NCI’s Landscape Survey Committee approval via Wake Forest link. Authorline requirements will be stated in the approval letter from NRG.
- Notification letters will articulate the rationale for any disapproval. The requesting investigator may use this information to resubmit an application after addressing the provided concerns.
- NCI’s Landscape Survey Committee will notify both the requesting investigator and NRG NCORP of the decision.
- If approved, NRG SDMC will prioritize the analysis within their workload. Highest priority is given to approved requests related to a concept. NRG Publications guidelines must be followed for all abstracts/presentations and manuscripts.