1. on [INSERT Day Month Year]
This is to certify that
INSERT NAME
attended the Orygen ICH E6 GCP (R2) GCP Training for Investigator Site Personnel Course Course/Presentation Slides Version 1, dated 3rd July 2017
on [INSERT Day Month Year]
The course content includes: Overview of GCP, Principles of ICH GCP, Investigator Responsibilities including Investigator Qualifications and Agreements, Adequate Resources, Medical Care of Trial Subjects, Communication with IRB/IEC, Compliance with Protocol, Investigational Products, Randomisation Procedures and Unblinding, Informed Consent of Trial Subjects, Records and Reports, Progress Reporting/Final Reports, Safety Reporting and Premature Termination or Suspension of Trial.
Certificate Number: [INSERT CERTIFICATE NUMBER] Expiry Date: [INSERT Day Month Year]
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
Certificate Version 1, dated 3rd July 2017