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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 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)

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