Training Program Title

Study Documentation: Regulations and Best Practices

Contributor

Duke University

CTSA Hub Administered

no

Contact Information

freels@duke.edu

Training Program Description

This course outlines the required components of study documentation for all clinical research, defines standard documentation terminology, and applies knowledge of documentation best practices to everyday scenarios faced by study teams. Course Objectives: Outline required components of study documentation for all clinical research Distinguish between documentation regulations and best practice Define standard documentation terminology Apply knowledge of documentation best practices to day-to-day documentation scenarios faced by study teams

Competency Keywords

Documentation, Best practice, Regulation

Digital Commons Disciplines

Medical Education

Public

no

Cost to Access

no

Competency Domains

Clinical Trials Operations

Learning Objectives

  1. Outline required components of study documentation for all clinical research
  2. Distinguish between documentation regulations and best practice
  3. Define standard documentation terminology
  4. Apply knowledge of documentation best practices to day-to-day documentation scenarios faced by study teams

Delivery Method

Combination of online and in-person

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

no

Frequency

On demand

Time Needed

1.5 hours

Associated Assessment

no

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