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ORA

Clinical Trial Checklist


Checklist for  Initiation  of Study Agreements Involving Human Subjects

INSTRUCTIONS:   ORA is responsible for the negotiation of agreements involving human subjects.  In order to do so the PI/Clinical Coordinator must provide the INITIAL DOCUMENTS listed below.  If the study will utilize any Tulane University Hospital and Clinic services,  procedures,  medical records and /or personnel  the ADDITIONAL DOCUMENTS must also be provided once they become available.

Documents may be submitted to ORA as follows:

  • E-mail to your ORA Research Administrator
  • Fax to 988-1748
  • Deliver to ORA Office @ Elks Place, Suite 201

 Initial Documents

__ Electronic Copy of draft Sponsor Agreement for proposed study

__ Protocol and/or Summary

__ Draft Informed Consent

__ Final study budget as soon as available.

___ Routing form 

(To assure that you have the most current version please download the routing form from the ORA website located at http://www.som.tulane.edu/researchadmin/forms.htm.  This form is frequently updated  to reflect changing regulatory requirements.)

Additional Documents  (required if any TUHC services, personnel  or medical records will be utilized in the study)

__ IRB approved Protocol  (only provide if changes were made to the one submitted with Initial Documents)

__ IRB Approval Letter

__ IRB Approved Consent Form (with IRB signed approval page) and HIPAA Consent Form

__ Cover letter addressed to Hospital including any additional information that may be needed.  (For example – the study is being funded internally)

__ Hospital Investigational Questionnaire with any additional attachments (TUHC form)

__ (Meditech) Client Study/Additions form (TUHC form)

__ Meditech Charge form (TUHC form)

 


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