Activity 3: Investigator Responsibilities
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.
Activity Worksheet Answer Keys
Quick Reference Card
Video 1: IRB Scenario
Video 2: Adherence to Protocol
Video 3: Drug Inventory
Video 4: Safety Oversight
Activity 4: Study Product Administration
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.
Activity 5: Institutional Review Board/Independent Ethics Committee (IRB/IEC)
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.
Activity 6: Informed Consent
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.
Activity 7: Essential Documents
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.
Activity 8: Source Documentation
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.
Activity 9: Safety Oversight
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.
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
Activity 10: Quality Management
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.
Activity 12: Causes, Solutions, and Forces
Activity 13: Regulatory Updates
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.