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
__ 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.
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