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Clinical Trial Checklist

Checklist for Initiation of Study Agreements Involving Human Subjects

INSTRUCTIONS:  SPA 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 SPA as follows:

  • E-mail to your SPA Research Administrator
  • Fax to 988-1748
  • Deliver to SPA 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 SPA 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)

__ TUHC forms. These forms can be found here. See Forms for HCA and also the applicable forms under the DUA forms.