IMPACT: Procedure Documentation for Clinical Trials

The IMPACT (Instruction in Monitoring, Procedure Documentation and ClinicalTrials.gov) workshop series provides intermediate instruction for faculty, clinical research professionals with two or more years of experience and other study team members. This workshop will introduce participants to best practices for creating, interpreting and using a manual of procedures (MOP) and other procedures documentation to ensure standardized practices across personnel and sites of a clinical trial. Topics will include an overview of sections to include in a MOP, what to do if a documented procedure isn't feasible and information about the new IRB requirement for uploading a MOP if you are coordinating a multi-site trial.

Learning Objectives

 

  1. Explain sections of a manual of procedures (MOP) and required content
  2. Compare differences between content of a MOP and a protocol
  3. Examine a sample MOP to identify causes of frequently occurring problems in development and implementation
  4. Evaluate sections of a MOP for clarity and feasibility

 

Competencies
Clinical trial operations
Study and site management
MICHR
Organization
Level
Skilled
Time Required
2 hours
Fee
No
Delivery Method
In-person
This content was originally submitted to the Development, Implementation, and Assessment of Novel Training in Domain-based Competencies (DIAMOND) project. DIAMOND is a collaborative effort by the University of Michigan, University of Rochester, The Ohio State University, and Tufts University to provide a nationally crowd-sourced, federated, online catalog for practitioners to find and contribute training and assessment materials. If you have questions or have updated information regarding this content, please email education@clic-ctsa.org.

Submitted by CLIC Admin on Sun, 01/10/2021 - 23:11 . Last modified on 02/18/2021