CONFORM Research Teams,

A combined PDF of the full Manual of Procedures, as well as individual PDFs of each section, are available for download on the  CONFORM Research Coordinator Portal.

Please note that a revised hard copy will not be sent to your site.

Below are links and overviews of the M.O.P. document sections and the updates to them.

• MOP02—Study Contact List V9.0 18Aug2025
  Updated contacts
  
  
• MOP03—Site Personnel Training Requirements V7.0 18Aug2025
  Added CLAAS AcuFORM IFU as required training for PI and Sub-I and clarify that GCP Cert must be current.
  
  
• MOP05— Study Schema Table V5.0 18Aug2025
  Updated to reflect Protocol Rev M.
  
  
• MOP06— Randomization V3.0 18Aug2025
  Removed requirement for 3+ scheduled CONFORM cases in order to randomized a subject on table. Randomization on table can now occur on a case-by-case basis with site PI and Conformal FCS
  
  
• MOP07a— CONFORM TEE Imaging Acquisition Protocol V6.0
  Added for convenience, 
  The previous MOP07a Imaging Method Flowchart has been obsoleted and replaced with MOP07a CONFORM TEE Imaging Acquisition Protocol V6.0.

• MOP07b— CONFORM TEE Checklist V4.0
  Added for convenience
  
  
• MOP07c— CONFORM CT Acquisition Protocol Rev A.
  Added for convenience
  
  
• MOP08— Device Accountability WI V3.0 18Aug2025
  Includes instructions that the VizaraMed Steerable Sheath is not investigational product and should not be entered in DA App
  
  
• MOP08a— Return Devices V3.0 18Aug2025
  Clarify that FedEx # should be entered in DA App for return shipments, moving forward RGA Slips are now available for site download within the DA App
  
  
• MOP08b— Device Accountability App V3.0 18Aug2025
  Update to clarify that electronic signature within the DA App is 21 CFR Part 11 compliant and can be sued in place of wet signature upon product receipt
  
  
• MOP12— Pre-Procedure Review Process V4.0 18Aug2025
  Pre-procedure review required only for each physicians first case
  If anatomy is unsuitable, review repeats for the next patient
  FAQ updated for clarity
  
  
• MOP-13—Will be provided at a later date

Please reach out to your assigned Site Manager with any questions about the updates. Thank you for your continued efforts toward the CONFORM Pivotal Trial.

We appreciate all that you do!

CONFORM Research Coordinator Portal 

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Drop us a note at info@conformalmedical.com.