Investigator-initiated studies (IIS) are studies conceived, initiated, conducted and sponsored under the full responsibility of a non-Roche Sponsor, such as an individual investigator, institution, university, collaborative group, cooperative group or association. The Sponsor must ensure that all legal and regulatory requirements are met and that the study is conducted and managed in accordance with all applicable laws and regulations.
Roche may support investigator initiated studies with drug supply, diagnostics assays, medical devices or solutions supply, funding, material and/or information, as allowed under local laws and regulations, provided that they align with the company defined areas of strategic interest.
Clinical studies of approved and investigational uses of Roche drugs or diagnostics assays, medical devices and solutions (interventional studies phase I to IV)
Clinical observational studies, real world evidence (non-interventional studies)
Studies allowing the use of biobanks or sample collection
Health economics evaluations and analytical studies
Non-clinical studies (with mice or mice feed). Requests for these can be submitted to Roche Pharma
Requests for compassionate use should be submitted to the Roche Pharma
Have the scientific, technical and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc.)
Have expert statistical support
Submit a scientifically well designed and well-written study proposal
Deliver to agreed timelines
Be able to fulfill all regulatory requirements (including submitting a IND/CTA, as applicable, writing of final study report and manuscripts etc.)
Deliver a written report of the final study results to Roche (GNE), as applicable
Publish the study in a scientific journal, as applicable
Agree to safety reporting to health authorities and to Roche (GNE), as applicable
Agree to provide study updates to Roche (GNE)
Researchers are invited to submit their concept proposal via a Roche IIS submission portal. Each submission will be reviewed collectively by the Roche Review Committee based on scientific merit and alignment with corporate research, key business objectives and development plans.
The requester will be informed about the outcome and should Roche be interested in the concept submission, the investigator will be contacted and invited to submit further details and a final protocol on the IIS in order to be considered for full approval.
Roche requires that the following documents are in place before support can be initiated:
A fully executed IIS agreement between the sponsor and Roche
A fully executed IIS safety data exchange agreement between the sponsor and Roche, as applicable
An EC/IRB and/or health authority approval
All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.
Download here the "IIS Requester User Guide" which provides you with step-by-step instructions on how to register and submit an IIS proposal.
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