Research Study Initiation Process

2014.06.14

GRU Clinical & Translational Research

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

INITIATING CLINICAL RESEARCH

Is a Confidential Disclosure Agreement ( CDA ) Required?

NO YES Contact - Office of Innovation and Commercialization to initiate steps Is an Information/ Site Questionnaire Requested by Sponsor?

NO YES Contact - Clinical Trials Office

Study Feasibility Process Initiated

Is this a Cancer Study?

NO YES Complete PRMC Application Commence Concurrent Research Processes Is an IND/IDE application required?

NO YES Contact – Office of Research Development Services for assistance (as applicable)

CONCURRENT RESEARCH INITIATION PROCESSES Agreements

(as applicable)

Budget & Finances Medication Management Additional Approvals

(as applicable)

IRB Submission Training & Education Conflict of Interest

Data Use Agreement (DUA) Material Transfer Agreement (MTA) Clinical Trial Agreement (CTA) All Agreements are negotiated

*Budget Preparation and Negotiation

Is this Clinical Trial conducted at a GR Medical Center location?

Final Budget is agreed upon and approved by Internal Resources and sponsors YES NO

eSProute Medical Center Approval

Negotiated Budget Details are included in the Clinical Trial Agreement Research Pharmacy Process Non Research Pharmacy Process Radiation Safety Biosafety Stem Cells Gene Transfer Recombinant DNA Select Agents & Toxins *Chemical Safety Data Management & Storage Is this an Investigator Initiated Trial?

Declarations are submitted to Conflict of interest Panel NO

External IRB Process

YES

Internal IRB Process

Completed Training Records are Submitted COI Panel reviews and provides recommendation to IRB Committee 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 DSPA ACTIVATES ACCOUNT DSPA collates and reviews budget details and verifies approvals (IRB, Ancillary, Budget, COI/Financial Disclosures)

Subject Recruitment may Commence

*A one-time process to be completed by PI, not required at the initiation of each new research study.

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.

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

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

The PI is responsible to ensure that all approvals are initiated and received Medical Center:

recommended

Chemical Safety: prior to research commencement.

If the study involves patients, clinics, medical records, and/or billing information, budget, and resource approval REQUIRED - routing via eSPRoute 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