Checklist for Initiation of Study Agreements Involving Human Subjects
INSTRUCTIONS: SPA is responsible for the negotiation of agreements involving human subjects. To initiate, 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
- Deliver to SPA Office @ Tidewater, Suite 909
__ Electronic Copy of draft Sponsor Agreement for proposed study
__ Protocol and/or Summary
__ Final study budget as soon as available.
__ Routing form. Current form available here: https://tulane.app.box.com/s/5dt0zr0hpsw0l6lmascmfyxpzt23zgzt *Please note that this form is updated frequently to reflect changing regulatory requirements so ensure you use the most current version available on the SPA website.
Required if any Tulane Medical Center (TMC) services, personnel or medical records will be utilized in the study. This includes Tulane Hospital, Lakeside Hospital, Tulane Childrens Hospital and all of the Medical Center related clinics that are operated by HCA Healthcare. In such cases, a work order is required with TMC. SPA must prepare the work order approval package for required Tulane and TMC approval signatures. Once all of the documents below are available, the PI/Clinical Coordinator should send all of the documents in one email to email@example.com
__ IRB approved Protocol (only required if changes were made to the one submitted with Initial Documents)
__ IRB Approval Letter (if a central IRB issues approval, Tulane's IRB Acknowledgment Letter must be included)
__ IRB Approved Consent Form(s) (if applicable or affirmative response if not applicable). Note: All consent forms listed in the IRB Approval Letter must be provided. If a Tulane approved study, Tulane IRBstamp must be on each of the consent forms. If a central IRB approved study, IRB signed approval page must be included.
__ HIPAA Consent Form
__ Completed TMC signed questionnaire, available here [link: https://tulane.app.box.com/s/v40ljx69dtn2x58uhg96vp9r8bdd4qv2] (includes instructions regarding information and approvals process for TMC)
__ Completed Meditech form (with all 4 signatures), available here
__ IT IRB Charge Copy (showing dept acct# & amount charged) (if applicable or affirmative response that it is not applicable)
Human Research Protection Office & IRBs: https://research.tulane.edu/hrpo (Informed Consent Template and Instructions are available on IRBManager).
Cover letter addressed to Hospital including any additional information that may be needed. (For example – the study is being funded internally)