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JHS Office of Research Application Form

 Research Facility 


 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 sent and uploaded by the JHS Office of Research.
  • Sponsor Contract (if applicable): The JHS Site Agreement or UM Work Order inclusive of the budget agreement 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 Gabriel Blaschke at Gabriel.Blaschkepola@jhsmiami.org
  • JHS Pharmacy: PI and study team MUST contact JHS Pharmacy for any costs estimates during study review process. An In-service is required before the initiation of the study. Contact Luis Alfonso at LAlfonso@jhsmiami.org


 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) to the JHS Office of Research within 24 hrs. of consenting a patient by via email ClinicalTrialsOffice@jhsmiami.org (which includes patient signature, MR number, Date of Consent) As per JHS Research Policy, I understand that failure to comply will lead to potential discontinuation of all research activities.
  2. I will place a copy of Research ICF in the patient's medical record.
  3. I will also provide monthly patient enrollment status using Appendix "A" (will be attached to JHS CRRC Approval Letter).
  4. I will ensure that payment is provided within 60 days of invoice received.