Research Study Initiation Process

1. Research Study Initiation Process • 2014.06.14

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

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

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

5. NEW REQUIREMENTS - • BEFORE IRB Submission! • 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. Requirements • 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 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. Requirements • Before COMMENCING RESEARCH! • 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 The PI is responsible to ensure that all approvals are initiated and received prior to research commencement.