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
- Define monitoring and its purpose in clinical trials
- Compare and contrast activities related to monitoring and auditing
- Identify and apply terminology related to clinical research monitoring
- 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