Study Submission & Research Billing Process

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The Office of Research & Grants requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Clinical Research Review Committee:

I. Drug Studies

  • Complete JHS Office of Research & Grants Study Application & Study Calendar
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/Sub-award agreement
  • Form 1572
  • FDA letter re: IND or IND Exemption
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • Questionnaires and/or Assessments
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

II. Device Studies

  • Complete JHS Office of Research & Grants Study Application & Study Calendar
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/ Sub-award agreement
  • Sponsor Device Description
  • FDA letter re: IDE or IDE Exemption
  • Determination of Local Fiscal Intermediary
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • Questionnaires and/or Assessments
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

III. Chart Review/Repository Studies  

  • Complete JHS Office of Research & Grants Study Application
  • Study Protocol
  • Electronic Modifiable Version of the Contract or Grant Award/Sub-award agreement
  • IRB Application and Approval Letter (may submit Pre-IRB)
  • JHS HIPAA or Waiver of Authorization
  • Informed Consent Draft
  • Clinical Trials set up fee

Forms:

Flowsheets:

Clinical Trials

Office of Research & Grants
Jackson Medical Towers
1500 NW 12th Avenue
Miami, Florida 33136
305-585-7226 (office)
305-585-6144 (fax)

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