Submission Related Forms for Ongoing Studies

Continuing Review Form

• eSubmission studies - For studies that originated online, create a PRAMS eSubmission to Continue a study.
   
• Paper-based studies  - For studies that originated with paper forms, submit the Progress Report Form via the IRB Drop Box on the hersheymed.net server. 

Modification Requests

• eSubmission studies - For studies that originated online, create a PRAMS eSubmission to Amend/Modify a study. 
    
•  Paper-based submissions - For studies that originated with paper forms, submit the Modification Request Form  via the IRB Drop Box on the hersheymed.net server.
  • Assurance Statement (Signature Page)
     
  • Guidance for Modifying Exempt Research

Please note:     Changes in Research Category  
Exempt -  A new IRB submission will be required for any changes to Exempt research that affect the review category and make the research qualify for IRB review. 
Expedited -  If changes are made to Expedited research that cause the study to require Full (Cconvened) Board review, a new eSubmission application and documents may be required for the research to undergo review .

• Update a Consent Form Header and Approval Stamp Box 
• Modify a Protocol Summary Abstract   

 

 

Protocol Exceptions

• All Submissions:  Submit all protocol exception requests via the IRB Drop Box on the hersheymed.net server until an online process is developed.
  • Protocol Exceptions - IRB Review Policy
    • Protocol Exception Request Form 
    • IRB Chair Contact Information

 

Reportable New Information (RNI) Process

• All Submissions:  Report information items that fall into one or more of the categories defined on the form below, by submitting the completed form and template along with any supporting materials. Submit RNI documentation to the IRB Drop Box via the hersheymed.net server until an online process is developed.
  • IRB Policies
    • Form - Reportable New Information
    • Template - Reportable New Information