WCG Academy Course Curriculum FINAL

1 Academy TM.. Powered by ComplianceWire WCG ACADEMYTM Course Curriculum . Curriculum CODE ROLE/TITLE. Investigator Investigator (basic) Role 1. (basic). WCG_Investigator Investigator Obligations WCG_Investigator Informed Consent Process WCG. WCG_Investigator Documentation of Informed Consent Investigator/. Investigator/ Drug Role 2. Drug WCG_Investigator Investigator Obligations WCG_Investigator Informed Consent Process WCG. WCG_Investigator Documentation of Informed Consent GCP01 GCP/ICH Obligations of Sponsors, Monitors and Investigators Obligations of Investigators in Conducting Drug and Biologic Trials *This ICH E6 GCP Investigator Site Training meets the Minimum Criteria GCP02* for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

2 Investigator/ Investigator/. Role 3. Device Device WCG_Investigator Investigator Obligations WCG_Investigator Informed Consent Process WCG. WCG_Investigator Documentation of Informed Consent GCP01 GCP/ICH Obligations of Sponsors, Monitors and Investigators GCP03 Obligations of Investigators in Conducting Medical Device Trials IRB Member IRB Member Role 4. WCG_IRB Introduction to the Criteria for IRB Approval WCG_IRB Criteria for Approval 1: Risk WCG_IRB Criteria for Approval 2: Risks and Benefits WCG_IRB Criteria for Approval 3: Equitable Selection WCG_IRB Criteria for Approval 4: Informed Consent WCG_IRB Criteria for Approval 5: Document Consent in Writing WCG_IRB Criteria for Approval 6: Safety of Subjects WCG_IRB Criteria for Approval 7: Privacy and Confidentiality WCG_IRB Criteria for Approval 8: Coercion of Vulnerable Populations vF250614.