1. Jefferson study team creates a new submission application in the IRB Portal following all institutional requirements.
    
   
   • Submission will be reviewed.

*If adding site(s) to existing study, follow the process beginning below:

1. Upon receipt of IRB approval, the study team creates an amendment application in the IRB Portal to add additional site(s).
    
   
   • Submission includes: OHR-12 (include name of local site, PI and key personnel, and summary of specific activities to occur at external site), proof of human subjects training for external PI and study personnel, partially executed Reliance Agreement (IRA), completed local context questionnaire.
   • If applicable, include site-specific consent form.
2. The amendment will be reviewed.
    
   
   • Upon approval of the amendment, the IRB will provide the study team with the executed IRA, approval letter, and approved site-specific consent.
3. The Jefferson PI and study team are responsible for providing all IRB-approved materials to local site PI and study team.

1. Jefferson study team creates a new submission application in the IRB Portal in order to process the reliance agreement.
    
   
   • Submission includes: OHR-1 (include Jefferson Personnel only), Protocol, summary of specific duties of Jefferson personnel and activities to occur at Jefferson, Main ICD, Approval Letter, Reliance Agreement (IRA).
2. The submission will be reviewed to verify eligibility to proceed with other Institutional IRB Review.
    
   
   • Once confirmed the partially executed IRA will be forwarded back to the study team and the submission will move forward.
3. The submission will be administratively reviewed.
    
   
   • If applicable, the consent forms will be reviewed to ensure Jefferson template language is included, and the study team will work with Jefferson IRB to complete any requested local context information.
   • Once correspondence is received from OHR confirming all applicable elements are in place, the study team will forward the study documents to the external IRB for review and approval.
4. The study team will email the executed IRA along with copies of the final approved protocol, consent form, and any additional materials approved for use at Jefferson.
5. Upon receipt of all required documents, Jefferson IRB will provide study team with Study Activation email.
    
   
   • Research activities may now commence.
   • As per the reliance agreement, the PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
   • The PI and study team are to provide Jefferson IRB with copy of annual and final reports submitted to the external IRB.