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  • Office of Research Administration

  • Research Administration Compliance:Research Study Document/Regulatory Binder

  • This handout information should be placed in a binder which will help organize your study and be a source that provides a complete and thorough history of your research study from protocol development to study completion.  The binder should include all versions of the study protocol, your standard operating procedures (SOP), Informed consent documents, recruitment materials, surveys/ questionnaire/ other instruments of your research study and correspondence between the IRB, sponsor and other regulatory bodies as applicable.  The purpose of this binder is to store and organize required study documents and correspondence. 

     

    Section A: Regulatory BinderBinder

    Section B:  Drug Device Binder Tabs

    Section C:  GCP Guidance Information

    Participant identifiable documents such as signed informed consents should be maintained separately in a subject specific binder/file.

     

     

    Please contact Jacqui Poore at 401-444-5843 or jpoore@lifespan.org if you have questions or require assistance