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Study Submission & Research Billing Process

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Hurricane Irma

Jackson Health System has resumed normal operations at a majority of its facilities.

The UHealth Jackson Urgent Care at Cutler Bay is now open
The UHealth Jackson Urgent Care center at Keystone Point is now open
The UHealth Jackson Urgent Care center at Country Walk is now open
The Jefferson Reaves remain closed due to power outages.

To reschedule an appointment, please call 305-585-6000. Updated information for UHealth Jackson Urgent Care centers is available at JacksonUrgentCare.com.

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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