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Research Study Initiation Process 2014.06.14. GRU CLINICAL AND TRANSLATIONAL RESEARCH LABORATORY RESEARCH ANIMAL RESEARCH HUMAN RESEARCH GRU Clinical.

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Presentation on theme: "Research Study Initiation Process 2014.06.14. GRU CLINICAL AND TRANSLATIONAL RESEARCH LABORATORY RESEARCH ANIMAL RESEARCH HUMAN RESEARCH GRU Clinical."— Presentation transcript:

1 Research Study Initiation Process

2 GRU CLINICAL AND TRANSLATIONAL RESEARCH LABORATORY RESEARCH ANIMAL RESEARCH HUMAN RESEARCH GRU Clinical Research GRU Social / Behavioral Research GRU Community Research GRU Educational Research GRU Clinical & Translational Research

3 INITIATING CLINICAL RESEARCH Preparatory Research Steps Complete PRMC Application Contact – Office of Research Development Services for assistance (as applicable) Study Feasibility Process Initiated Is an Information/ Site Questionnaire Requested by Sponsor? YES NO Contact - Clinical Trials Office Is this a Cancer Study? Commence Concurrent Research Processes Is a Confidential Disclosure Agreement ( CDA ) Required? Contact - Office of Innovation and Commercialization to initiate steps Is an IND/IDE application required? YES NO YES NO YES NO

4 DSPA collates and reviews budget details and verifies approvals (IRB, Ancillary, Budget, COI/Financial Disclosures) Conflict of Interest Declarations are submitted to Conflict of interest Panel COI Panel reviews and provides recommendation to IRB Committee IRB Submission Is this an Investigator Initiated Trial? YES NO Internal IRB Process External IRB Process Clinical Trial protocol is submitted to IRB Committee (External & Internal) for review. GRU IRB Office issues IRB Committee Approval Letter to PI. Training & Education Completed Training Records are Submitted Additional Approvals (as applicable) Additional Approvals (as applicable) Radiation Safety Data Management & Storage *Chemical Safety Medication Management Research Pharmacy Process Non- Research Pharmacy Process Is this Clinical Trial conducted at a GR Medical Center location? YES NO Budget & Finances *Budget Preparation and Negotiation eSProute Medical Center Approval Final Budget is agreed upon and approved by Internal Resources and sponsors Negotiated Budget Details are included in the Clinical Trial Agreement CONCURRENT RESEARCH INITIATION PROCESSES Agreements (as applicable) Agreements (as applicable) DSPA ACTIVATES ACCOUNT All Agreements are negotiated Subject Recruitment may Commence Data Use Agreement (DUA) Material Transfer Agreement (MTA) Clinical Trial Agreement (CTA) CTA is finalized and executed *A one-time process to be completed by PI, not required at the initiation of each new research study. Biosafety Other Biosafety Stem Cells Gene Transfer Recombinant DNA Select Agents & Toxins

5 Biological Safety Approval if the study involves: Recombinant or Synthetic Nucleic Acids Gene Transfer/Therapy DNA Vaccines Stem Cells Select Agents & Toxins Process: A full IBC application is required for studies involving these categories Radiation Safety Approval if the study involves: Ionizing radiation outside of standard of care procedures Process: The IRB Application should be initiated and SHARED with Radiation Safety Committee to review and approve.

6 Biological Safety: If study involves exposure to other biological material, but not a specified category Process: Complete form (available in IRBNet) and submit to IBC Office Radiation Safety: If exposure is standard of care - complete form (available in IRBNet) and submit to Radiation Safety Office Medical Center: If the study involves patients, clinics, medical records, and/or billing information, budget, and resource approval is REQUIRED - routing via eSPRoute recommended Chemical Safety: A ONE registration is required, which covers all protocols involving chemicals Data Security & Storage (ITSS): Attestation submitted at time of IRB Submission Secure data storage location requested via IT Service Desk

7 Required Approvals BEFORE COMMENCING RESEARCH Biological Safety: If study involves exposure to other biological material, but not a specified category. Process: Complete form (available in IRBNet) and submit to IBC Office Radiation Safety: If exposure is standard of care - complete form (available in IRBNet) and submit to Radiation Safety Office Medical Center: If the study involves patients, clinics, medical records, and/or billing information, budget, and resource approval REQUIRED - routing via eSPRoute recommended Chemical Safety: If the study involves chemicals a chemical number is required Data Security & Storage (ITSS): Attestation submitted at time of IRB Submission Secure data storage location requested via IT Service Desk


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