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  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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