Study Start Up

Materials

The sponsor of the trial will provide the relevant study materials to the Emory investigator (e.g., the investigator’s brochure, protocol, financial disclosure statements, and clinical trial agreement). When the trial is investigator-initiated, the Emory investigator will need to obtain the written information on the drug/device and is responsible for the development of the written protocol and informed consent forms. 

The investigator must develop the informed consent form by using the Informed Consent Template on the Emory IRB website. This template contains required language and the IRB stamp placeholder. If the sponsor provides the investigator with a sample informed consent form, the investigator will need to incorporate the required Emory language and IRB stamp placeholder from the IRB Informed Consent Template.

Required Approvals at Emory

There may be multiple approvals required for your clinical trial. Please see Appendix 1 at the end of this guidance to determine which committee approvals are necessary for your clinical trial.

Study Start Up Checklist

1. Obtain study material from sponsor; if investigator-initiated, obtain written material on the drug/device and develop the written protocol and informed consent form utilizing the templates on the Emory IRB website (https://www.irb.emory.edu/forms/protocol-templates.html and https://www.irb.emory.edu/forms/consent/index.html)

Note! If the sponsor requires you to sign a confidentiality disclosure agreement (CDA) prior to sending you the study material, submit the CDA to the Office of Sponsored Programs for approval before signing it.

2. Identify study personnel

3. Decide which Emory approvals you need to obtain (see CTAC Guidebook Appendix 1) and complete applications

IRB submission via eIRB for Emory IRB

• • Visit Emory IRB’s Getting Started Webpage (link: https://www.irb.emory.edu/guidance/getting-started/study-submission.html)
  • If you plan for Emory IRB to serve as the IRB of record for a multisite study or Emory to rely on another institution’s IRB or commercial IRB, visit the Emory IRB Collaborative Research page (link: https://www.irb.emory.edu/guidance/research-types/collaborative.html)

OCR submission via Clinical Research eForm (link https://ocr.emory.edu/resources/systems/ocr-cr-eform-app.html) for studies with billable items and services from Emory Healthcare or Grady

OSP submission via EPEX for federal and foundation grants

OTT submission for industry-sponsored research (link: https://ott.emory.edu/resources/forms.html)

ORIC submission for sponsor-investigator studies

COI submission via eDisclose

Radiation safety, if applicable

Biosafety, if applicable

IDS submission, if applicable. If studies are already routed through OCR, OCR will initiate the contact to IDS.

Emory Healthcare Office of Quality Checklist

Clinical Research Key Points Summary

Request for Sensitive Study Status Worksheet, if applicable

Grady Office of Grant Administration. Seek financial clearance for all studies using Grady as a site.

clinicaltrials.gov

Note! If changes to protocol or other study materials occur during IRB submission and before approval, submit the revised documentation to OCR and OSP as well to eliminate delay to approval

4. After IRB approval seek the following approvals, if applicable

• GROC (Grady Research Oversight Committee)
• VA R&D (Veterans Affairs Research Development Committee)
• Emory St. Joseph’s or Johns Creek approval

Children’s Healthcare of Atlanta IRB Authorization Acknowledgement Form

5. Ensure proper institutional credentialing and training of study personnel (see CTAC Guidebook Chapter 2)

6. Document study-specific protocol, reporting, and EDC training for each study team member

7. Complete the Form FDA 1572 (drug studies) or Investigator Agreement (device studies), if applicable

8. Develop or complete the Delegation of Authority (DOA) log with specific study tasks delegated from the PI

When to Apply to the Departments Listed Above

For the quickest time to approval, researchers may apply to multiple departments simultaneously. Apply to the following offices as soon as the required materials become available:

COI:  Complete eDisclose after you submit the eIRB application

IRB:  Submit eIRB application when the following become available: written protocol, draft informed consent form, drug/device information, and recruitment materials.

OCR:  Email materials to OCR when the following become available: written protocol, draft informed consent form, contract, and draft budget.

OSP:  For federal and/or foundation grants, submit proposal in Emory Proposal Express (EPEX) when the grant is available.

OTT:  For industry-sponsored research, submit when contract becomes available

References

Emory IRB Policies and Procedures (https://www.irb.emory.edu/guidance/index.html); Emory University Policies and Procedure; HIPAA Security Policy; FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions—Statement of Investigator (Form FDA 1572)