Grady Memorial Hospital (GMH)

Grady Memorial Hospital (GMH)

If you are submitting to OCR and you are enrolling subjects at GMH, please complete the following:

1. Emailed all appropriate documents below to or submit documents in EPEX if your study has any billable items or services at Emory Healthcare.

· Request for PRA & Budget Development form

· Protocol

· Draft Clinical Trial Agreement (CTA) or contract

· Investigator Effort Calculation Report

· Draft budget

· Informed consent – Emory or sponsor draft

· Most recent FDA communications, e.g., IND letter that includes IND number, IDE letter that includes IDE number and category assignment

2. Additionally, for study start-up processes, contact Chad Anderson at or Shirley Marshall at . For GMH’s budgetary requirements contact David Noble at or .

3. For more information, review Grady’s website for the following:

· Grady Office of Grants Administration

· Grady Office of Research Administration