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Documents for Implementing Remote Trial Management

C3 Summit: Mana RBM Documents for Implementing Remote Trial Management

Adopting new processes and technology is never easy, and implementing a new remote trial management solution is no exception. Sponsors and sites of all sizes are looking at how remote trial management solutions can help them provide the flexibility, speed, and oversight necessary to operate in uncertain times. In our C3 Summit session, Implementing Remote Trial Management: Proven Approaches for a Quick and Effective Launch, Michael Smyth, Division President of Trial Interactive, and Penelope Manasco, MD, CEO of MANA RBM, discussed key considerations for effectively launching a remote trial management solution for current or upcoming studies. Here are 8 key documents shared by MANA RBM to help your teams implement a remote trial management solution that is accessible, scalable, and capable of eliminating the top five regulatory inspection findings.

They include:

  • Vendor selection criteria (ePRO/eSource/eConsent/eTMF/eISF)
  • Electronic signature attestation template
  • Letter for certification (letter to the FDA)
  • Vendor audit template
  • Certification for the use of electronic signatures
  • Instructions for generating and using certified copies
  • Checking the regulatory status of investigators and sub-investigators instructions

These documents are intended to be used only as reference material to help organizations draft their own company-specific documentation. These documents are for informational purposes only and not for redistribution or commercialization. Copyright for the contents within belongs to MANA RBM and Penelope Manasco, MD.