Training Program Title

Clinical Research Training Workshop

CTSA Hub Administered

yes

Training Program Description

The Clinical Research Training Workshop - also known as Research Basics - is designed for clinical research professionals who are new to research. This introductory program includes four modules that outline fundamental concepts and skills needed for the successful implement of a clinical research study. Training materials include slides, lecture scripts, facilitator's guides and instructions for hands-on skills activities done in small groups. Key information for program success as well as specialized information and tips for instructors is also included. The program provides basic instruction in the roles and responsibilities of research study team members, implementation of research best practices, creating and maintaining source documents and study binders, necessary components of informed consent documents, and strategies to enhance communication during the informed consent process. Information and activities in the program will engage participants and provide opportunities for hands-on skill building and learning. Each module includes learning goals and objectives, a complete list of materials needed, detailed instructions for each learning activity, and important resources. The program materials are offered as a guide and can be adapted for a specific institution and local needs.

Competency Keywords

GCP (Good Clinical Practice), Essential documents, Record retention, Research study management, Teamwork

Digital Commons Disciplines

Medical Education | Medicine and Health Sciences

Public

yes

Cost to Access

no

Competency Domains

Ethical and Participant Safety Considerations; Clinical Trials Operations; Data Management and Informatics; Communication and Teamwork

Learning Objectives

  1. Define the roles of study developers, data managers, study coordinators, statisticians, and study monitors in data management,
  2. Recognize frequently occurring data problems when implementing a research study,
  3. Implement best practices for data management,
  4. Identify regulations pertaining to the informed consent process,
  5. Identify strategies for assessing participant understanding during the informed consent process,
  6. Demonstrate measurable communication skills when interacting with potential study participants and their families,
  7. Define GCP and explain its impact on the research process,
  8. Define non-compliance,
  9. Identify preventive actions to avoid non-compliance,
  10. Identify at least 2 types of source documents and at least 4 items usually found in a regulatory binder,
  11. Recognize errors in source documentation,
  12. List techniques for maintaining a regulatory binder

Delivery Method

In-person

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Onboarding

no

Frequency

Annually

Time Needed

8 hours. Program materials can be downloaded to present the 4 module workshop. Each module takes approximately 2 hours to complete.

Associated Assessment

no

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