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JHS Office of Research Application Form

 Research Facility 


 Will this study be performed on a JHS Unit/Floor? 



 Study Details 












 






 





 


 







 Funding Source 




 Type of Study Submission 




 JHS Research Activities 


































 Additional Resources Required 



















 ENROLLMENT CHECKLIST 
Study enrollment cannot begin until below checklist has been completed.
  • IRB Approval: Study MUST be approved by the IRB of Record for the JHS Office of Research.
  • For Device Studies: Centers of Medicare Services (CMS) approval letter from Sponsor and determination of local Medicare Administrative Contractor (CMS approval prior to final approval).
  • JHS Clinical Research Review Committee (CRRC): The JHS CRRC must approve the study and an approval letter will be uploaded to the IRB system(If applicable).
  • Sponsor Contract (if applicable): The JHS Site Agreement or UM Work Order inclusive of the budget MUST be signed by JHS and UM (if applicable).
  • JHS Staff Approval: Staff on affected floors MUST be in-serviced on the research study and a copy of the signed in-service log MUST be submitted to JHS Office of Research. Contact Elena Castillo at ECastillo@jhsmiami.org

 Contact List 


 Important Information 
I understand that I cannot start my study until the above checklist is complete and I have received the JHS CRRC Letter.
    Once my study is approved:
  1. I will submit a signed Research Informed Consent (ICF) and HIPAA authorization to the Jackson Office of Research within 2 business days of consenting the patient, via email ClinicalTrialsOffice@jhsmiami.org (includes patient signature, MRN, Date of Consent) as per JHS Research Policy 819. Click here to open Policy document.
  2. I will place a copy of Research ICF HIPAA authorization form in the patient's medical record.
  3. I will also provide monthly patient enrollment and chart review form status using Appendix "A" Provided with JHS CRRC Notification of Approval.
  4. I will ensure that payment is provided within 60 days of invoice received.