Training Program Title

IMPACT: Procedure Documentation for Clinical Trials

CTSA Hub Administered

yes

Contact Information

UM-MICHR@umich.edu

Training Program Description

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.

Competency Keywords

Best practice, Documentation, Standard Operating Procedure (SOP)

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Clinical Trials Operations; Study and Site Management

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

Delivery Method

In-person

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

Annually

Time Needed

2 hours

Associated Assessment

yes

Assessment Methods

Overall satisfaction, Observed skills or behavior

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