GCP for Investigators: Clinical Investigation Conduct and Reporting
Course Description:
This course reviews important elements for conducting clinical investigations.
It covers the following topics:
- Effective team–sponsor communication to ensure compliance
- Investigator involvement during monitoring visits
- The informed consent process
- The device accountability process
- Data and other study-related requirements
- Reporting
The content of is course is based on:
- ISO 14155: 2020 Clinical Investigation of Medical Devices for Human Subjects
- The Declaration of Helsinki
- 21 CRF 812: Investigational Device Exemption
- 21 CRF 50: Protection of Human Subjects
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Identify and apply effective methods to keep sites in compliance during clinical investigations
Who Should Enroll:
Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical side of medical device clinical investigations are all encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- GCP for Investigators: Introduction to Medical Devices (ID 193)
- GCP for Investigators: How to Qualify for Medical Device Clinical Investigations (ID 200)
- GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (ID 212)