The Research Development Program (RDP) is a resource for clinical investigators, study coordinators and other study staff. The RDP offers aid in the development of study documents as well as to help facilitate the administrative processes for approval of protocols and other study documents from the Institutional Review Board (IRB) and other regulatory groups at BWH.
SERVICES
Guiding investigators through the stages required for development of research plans and documents is our primary goal. To this end, we provide the following types of assistance:
Review existing protocol forms prior to the IRB
Conversion of research projects into full study documents
Development of study plan and documents from investigator concept
Provide a tracking mechanism whereby areas of delay in approval can be identified and addressed.
LEVELS OF ASSISTANCE
Review of Clinical Research Documents
Investigator has completed the draft form of the IRB application, but would like review by experienced personnel prior to submission to the IRB for expeditious approval. Services available for new submissions, amendments, and annual reviews.
Creation of Clinical Research Protocol and Regulatory Documents
Investigator has a clinical research project and needs assistance converting it into a working protocol document for IRB and/or regulatory approval (i.e. converting a grant into a protocol, IRB application, consent form, medication forms, nursing form, etc).
Clinical Research Project Consultation Service
Investigator has an idea (hypothesis) and needs help in developing it into a clinical research protocol.
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