Master Alliance Provisions Guide (MAPGuide)

WHO Template Material Transfer Agreement

  • Information sharing & data safety

§9: Sharing Information

(a) Each Party shall, on request, disclose to the other Parties, in the form of written documentation, on a confidential basis in accordance with the terms of paragraph 10 below, all data and information already available to it, or developed by it during the course of this Collaboration Agreement, relating in any way to the Purpose.

(b) Each party should take the responsibility to ensure that results – even when preliminary – are adequately robust and have undergone quality control, prior to public disclosure.

(c) Each party has an obligation to publicly disclose quality controlled interim results according to a specific expedited timeline commitment for results sharing that should be made in protocols and analysis plans before trial commencement.

(d) Prior to the start of any clinical trial (ie prior to the first subject receiving the first experimental intervention) a clinical trial registry entry is to be made on a WHO ICTRP primary registry. Where the registry has a results summary section, public disclosure of interim and final results should occur using the results summary component of the registry.

(e) Final results are to be publicly disclosed, no later than 28 days after the primary study completion date, using the results summary section of the registry entry.