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Each document attached within the Protocol Registration and Results System (PRS) requires a cover sheet bearing the official study title, NCT number, and date of the document. This generic cover sheet template can be completed with the details for your IRB-approved protocol and Statistical Analysis Plan (SAP) documents. Use Adobe Acrobat to combine the two document files (cover sheet + document) and save in archivable PDF/A format (required) prior to upload into the Protocol Registration and Results System (PRS).

If you have any questions about these requirements or need help registering or reporting results for your clinical trial, please contact:

  • Melahat Canter for Lineberger Comprehensive Cancer Center (LCCC) & oncology clinical trials
  • Monica Coudurier for all other clinical trials (non-LCCC or oncology trials)