Archive: General Page

  • OnCoreā„¢ Clinical Trial Management System

    OnCore CTMS Overview The On-Line Collaborative Research Environment (OnCore) is a comprehensive web-based suite of research modules that integrates all of the components of research activity admin

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  • Clinical Research Training

    Update – OnCore CTMS Training sessions.

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  • Forms

    Participant Payment Request Form The IRB-approved Informed Consent Form, which indicates participant stipend amount, will need to be submitted with this form. Forte Compensation Card Request F

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  • Rheumatology Trials

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  • Common Regulatory Documents

    */ Document Purpose & Tips File Regulatory Reference Monitoring Reports, Log, and Correspondence (See #1 of the Regulatory Binder) The reports document the findings of the monitor, us

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  • Georgetown University Clinical Research Unit

    Many clinical trials can be conducted in whole or in part on the Georgetown University Clinical Research Unit (CRU), which is funded by a Clinical and Translational Services Award (CTSA) from the Nat

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  • Working with the Research Pharmacy

    Medstar Georgetown University Hospital requires that any drug supplied by a study sponsor for use in a clinical trial be stored, prepared, and dispensed by the Research Pharmacy. The CROO can provide

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  • Working with Laboratories

    Central Outside Labs If your study will use a central lab (a lab outside of MGUH), there will be specific instructions for obtaining, processing, storing, and shipping samples described in your st

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  • Regulatory Binder

    Essential documents The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data pro

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  • Institutional Biosafety Committee

    The Institutional Biosafety Committee (IBC) reviews and monitors all clinical research studies involving infectious agents, hazardous chemicals, recombinant DNA, and genetically altered organisms and

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