Training Program Title

IMPACT: Monitoring 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 in preparing for and participating in clinical trial monitoring visits. Topics include understanding the purpose of monitoring and how it differs from an audit, what to expect from different types of monitoring visits, and tips on responding to follow-up letters and reports.

Competency Keywords

Regulatory guidelines, Monitoring, Quality assurance, Quality assurance

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Clinical Trials Operations; Study and Site Management

Learning Objectives

  1. Define monitoring and its purpose in clinical trials
  2. Compare and contrast activities related to monitoring and auditing
  3. Identify and apply terminology related to clinical research monitoring
  4. Recommend actions to be taken in response to monitoring reports and letters

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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