Best Practices

Under the TEAMSS award, we plan to develop, demonstrate, and disseminate best practices of Expanded Access programs across the CTSA consortium. We aim to develop best practices that include recommendations in each of the following areas:

  • Processing expanded access requests at academic medical centers
  • Verifying expanded access criteria and assessing urgency
  • Navigating manufacturer approval including contractual agreements and letters of authorization
  • Seeking FDA and IRB authorization including preparation, submission, and timing of regulatory applications
  • Informing physicians of sponsor and investigator responsibilities
  • Receiving, preparing, and dispensing investigational products
  • Consenting patients and documenting use of investigational products in the electronic medical record
  • Collecting patient data and maintaining regulatory applications
Important Dates

Submitted by CLIC Admin on Tue, 08/20/2019 - 20:41