Data and samples access
Any researcher (French or foreign) can request access to the data and samples collected by OFSEP by submitting a research project. Projects are evaluated following the submission procedure described below.
|Deadline for project submission||Scientific Board session date|
|Monday, September 2nd 2019||Tuesday, September 24th 2019|
|Monday, October 28th 2019||Tuesday, November 19th 2019|
- Description of data available, v2 (07/2016)
- biological samples catalogue, v3 (10/2018)
- OFSEP presentation brochure for projects leaders
How to access OFSEP data?
Whether you are from academia, industry or an institution (or elsewhere), you must submit a project request before being able to access the data.
1st step: letter of intent (brief description of the project)
A letter of intent must be sent to the NCC briefly describing the project (objectives, prospective or retrospective study, type of data required, etc.). You will then have to submit a detained request, unless it is impossible for OFSEP to fulfill your request.
The partnership manager (academic or industry) will contact you and be your priority contact throughout the duration of your project.
Optional step: assistance from the NCC
The NCC can help you to prepare your project before submission to OFSEP's Scientific Board (SB). Its knowledge of the data and the pathology, the analysis methods and the participant network makes the NCC an ideal source of help to adapt your protocol, if necessary. The modifications proposed do not represent a commitment from the Scientific Board, but they do improve your chances of a favorable opinion.
2nd step: submission of the project using the specific form
3rd step: evaluations and decision
Project evaluation, which is based on the Scientific Board, is arranged every two months and takes place in three stages:
- The NCC evaluates the technical and operational feasibility of the project, and the methodology aspects.
- The Scientific Board evaluates the methodology and scientific pertinence, having consulted the NCC report and sought an opinion from internal or external assessors.
- The OFSEP Steering Committee validates or invalidates project implementation via OFSEP on the basis of the opinions given by the SB and NCC.
4th step: drafting of contracts
This step defines the contractual framework, including aspects regarding intellectual property, budget (activity of the OFSEP participant centers, specific project team within the NCC, data management and analysis, drafting of reports, etc.), project calendar and deliverables to be provided.
5th step: project implementation
- For a prospective study: the NCC provides a project team to ensure study monitoring (relations with the participant centers, relations with the sponsor, etc.)
- For prospective and retrospective studies: the data are managed by the NCC data manager and analyzed by the NCC statistician (raw data can only be available in certain very specific circumstances)
6th step: scientific communication
Any scientific communication made as part of a project involving OFSEP data, must comply with the publication charter and be sent to the relevant partnership manager.
OFSEP also proposes partnership contracts to industrial parties, providing them with a regular inventory of the cohort and aggregate data on patients under treatment, respecting confidentiality rules, and enabling access to OFSEP data under preferential conditions. For further information, please contact the industrial partnership Manager.