The DAIDS Applied Research Training (DART) pilot event focused on strengthening Good Clinical Practice (GCP) and International Council for Harmonization (ICH) compliance at clinical research sites through an innovative approach centered on small group, application-focused learning experiences.
The following training toolkits from the DART pilot event are free for sites to use to help support staff training.
Self-paced video module designed to provide a concise introduction to clinical research.
Facilitate group discussion on GCP key concepts. Generate active discussion by using twenty question cards to get people talking about GCP and how it applies at their site.
Facilitate group discussion related to Investigator Responsibilities (IR). Generate the group work and discussion by watching four video scenarios related to IR. Document the action items on the worksheets to promote discussion and collaboration among participants as they complete a Corrective and Preventive Action (CAPA) exercise and a Responsible, Accountable, Consulted, Informed (RACI) matrix.
Facilitator Instructions
Slide Deck
Activity Worksheet
Activity Worksheet Answer Keys
Quick Reference Card
Video 1: IRB Scenario
Video 2: Adherence to Protocol
Video 3: Drug Inventory
Video 4: Safety Oversight
Facilitate group discussion related Study Product Administration best practices. Generate the group work and discussion by reading 1 or 2 scenarios and answering guided questions to determine appropriate corrective and preventive actions.
Facilitator Instructions
Scenario 1 Worksheet
Scenario 2 Worksheet
Slide Deck
Facilitate group discussion related to IRB/IEC best practices. Generate the group work and discussion by reviewing scenario cards to determine what should be reported to the various ethics committees and at what stage in the trial the event(s) should be reported.
Facilitator Instructions
Slide Deck
Scenario Cards Table 1
Scenario Cards Table 2
Scenario Cards Table 3
Scenario Cards Table 4
Header Poster Titles
Activity Answer Key
Facilitate group discussion related to various Informed Consenting challenges. Generate the group work with a short role play where learners are asked to identify incorrect actions or consenting concerns as well as review scenarios and discuss and determine consenting best practices.
Facilitator Instructions
Slide Deck
Topic Cards
Role Play Activity Instructions
Activity Worksheet
Activity Posters
Quick Reference Card
Facilitate group discussion related to Essential Documents and Best Practices. Generate the group work by having participants review and identify essential documents as well as identify Good Documentation Practice (GDP) errors on the documents and utilize an essential document checklist.
Facilitator Instructions
Slide Deck
Activity
Activity Answer Key
Label List
Activity Rubric
Activity Rubric Answer Key
Quick Reference Guide
Facilitate group discussion related to Source Documentation and Best Practices. Generate the group work by having participants review the progress notes, scenarios and determine if they adhere to GDP compliance. Participants review and discuss and respond to guided questions.
Facilitator Instructions
Slide Deck
Activity
Activity Answer Key
Quick Reference Card
Facilitate group discussion related to the importance of adhering to Good Clinical Practices as they apply to adverse events (AE) and serious adverse events (SAE). Generate the group work using a role play activity where participants are asked to take part and then discuss and answer guided questions. In addition, a case study is provided for groups to review and discuss and respond to guided questions.
Facilitator Instructions
Slide Deck
Role Play Activity
Role Play Activity Guiding Questions
Role Play Activity Answer Key
Case Study Activity
Case Study Guiding Questions
Case Study Answer Key
Quick Reference Card
Facilitate group discussion related to the importance of Quality Management, Quality Assurance, and Quality Control by reviewing a case based-scenario using examples of a Warning Letter that a clinical research site received from the Food and Drug Administration (FDA). Groups will use this case study to review and discuss and respond to guided questions.
Facilitator Instructions
Slide Deck
Warning Letter Activity
Warning Letter Activity Guiding Questions
Warning Letter Activity Answer Key
Quick Reference Card
Facilitate group discussion related to the basic principles of Good Documentation Practices (GDP) by a question and answer activity using a Power Point presentation or Audience Response System (ARS).
Facilitate group discussion to identify and review essential standards of Good Documentation Practices (GDP) using techniques to analyze potential causes of poor GDP compliance and consider strategies for improvement.
Facilitator Instructions
Slide Deck
Force Field Analysis Poster
Facilitate group discussion related to challenges and strategies of staying current with changing requirements for clinical trial submissions, country, and other regulatory entities. Group activity includes brainstorming strategies for handling various scenarios that clinical sites may experience.
Facilitator Instructions
Slide Deck
Activity Worksheet
Activity Roadblocks
Activity Handout
Activity Poster