Training Program Title

Office for Human Subjects Protection Core Training - Module 7 Investigational Products

CTSA Hub Administered

yes

Training Program Description

The goal of the core training modules is to cultivate advanced understanding of research topics. Each of the ten learning modules covers a different topic area.

Competency Keywords

Investigational products, Device, Drug, FDA (Food and Drug Administration), IDE (Investigational Device Exemption), IND (Investigational New Drug or Device)

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Scientific Concepts and Research Design; Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management; Data Management and Informatics

Learning Objectives

  1. Define essential documentation and determine what type of documentation must be maintained, based on the nature of the research
  2. Differentiate between source documentation and study documentation
  3. Apply best practices in developing and maintaining study documentation
  4. Summarize good documentation practices

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

yes

Frequency

Annually

Time Needed

1 hour

Associated Assessment

yes

Assessment Methods

Learning outcomes

Share

COinS