About this Manual of Operations

ABOUT THIS Manual of Operations

 

Purpose

  • This manual is a reference to assist in all phases of the BRAVE clinical trial, including initiation, process, monitoring and closure. These are the manual’s specific objectives
  • Procedure standardization for study personnel
  • Procedure standardization at participating study centers
  • Provide clear definition of terminology and procedures
  • Provide clear delineation of roles and responsibilities
  • Provide expanded procedure details as they relate to the Standard Operating Procedures (SOPS)
  • Provide guidance for those centers whose Standard Operating Procedures and Manual of Operations procedures require deviation from the guidelines contained in this document

 

Scope

This manual provides specific methods and step by step instructions for conducting the BRAVE clinical trial.  It includes all aspects from the initiation of the study through testing and reporting, to closure.  These specifics relate to:

 

  • How to begin a study
  • Procedure requirements
  • Personnel conduct and responsibilities
  • Patient consideration
  • Testing methodology
  • Form completion instructions
  • Source document retention
  • Data transmission
  • Closeout procedures