Training Program Title

IMPACT: ClinicalTrials.gov

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. Before attending this session, participants should have either used ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training. This workshop will describe new requirements for registration, updates, use of special informed consent language, results reporting, and protocol uploads in ClinicalTrials.gov. Hands-on activities within ClinicalTrials.gov and group discussions will help participants learn how to avoid common mistakes. Topics include how to draft arms and interventions, translating protocol aims into specific outcome measures, and results reporting for different clinical trial models.

Competency Keywords

Regulation, Reporting requirements, Clinicaltrials.gov, Study design

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Study and Site Management

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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