Preliminary information on the identity of the Lead Researcher and on the Research Proposal must be submitted using the Preliminary Identification Form.
Chiesi conduct an initial evaluation of the submitted information and, based on this assessment, the Researcher may be granted with the access to the password-protected and reserved area of the Chiesi Clinical Trial Data Request Portal.
Upon registration and login into the reserved area of the Clinical Trial Data Request Portal, the Researcher can submit the request for clinical trial data through the Research Proposal Form.
A complete and valid Research Proposal must contain:
- Detailed description of the data being requested;
- Detailed description of the rationale of the proposed research with bibliographic references and copy of the cited papers;
- Details explanation of the hypothesis to be tested;
- Detailed research design and objectives;
- Proof of Ethics Committee or Institutional Review Board approval or commitment to provide proof of approval before any data is accessed (if necessary);
- Statistical Analysis Plan that will be used for the analysis;
- Publication and posting plan;
- Description of any potential competitive use of the data;
- Detailed and documented description of the source of any research funding;
- CV of every member of the research team;
- Description of any potential conflict of interest.
Once received the Research Proposal Form, Chiesi assesses and ensures that the Researcher’s request is complete and valid as per the above requirements. If and when the request is deemed valid and complete for formal acceptance, an appointed Chiesi Evaluation Committee starts the assessment of the Research Proposal.
- In case of a positive evaluation, Chiesi formally approves the research proposal.
- In case of a negative evaluation, but no direct competition is envisaged, Chiesi forwards the assessment to a Scientific Review Board, composed by qualified researchers who are not Chiesi employees. For more details about the Scientific Review Board, please contact email@example.com.
Within 90 working days from Research Proposal acceptance, Chiesi commits to informing the Researcher of the final decision and of any condition for collaboration.
Following the Research Proposal approval, signing of the Data Sharing Agreement between Chiesi and the Researcher or related Institution is the condition for granting the access to the required clinical data via a password-protected environment.
Within 90 working days from the Data Sharing Agreement signature, Chiesi commits to making available the requested clinical trial data.