Safety Reporting Requirements 2 course Suite
Safety Reporting Requirements 2 course Suite
This suite of 2 courses provides a review of the overall regulatory requirements in EU, US and JAPAN; which documents are applicable and what the different reporting requirements are for both competent authorities and ethics committees. This course will be updated constantly with individual National Competent Authority requirements
ID: 79
45 minutes
2 trainings
| Course | ID | Duration | |
|---|---|---|---|
US Safety Reporting Requirements during Pre-Market Clinical Trials |
90 | 20 minutes | |
European Safety Reporting Requirements during Clinical Investigations |
82 | 25 minutes |
Learning Objectives
The learner will be able to distinguish the different reporting requirements throughout EU, US and Japan for adverse events during clinical investigations
Who Should Enroll
Primary BoK – related topic # Clinical Evaluation 1.19, 1.20, 1.22
Level of Primary BoK: CMDA
Geographic region: EU and USA
Secondary BoK (cross functional): Regulatory
Prerequisite Knowledge
A full understanding of the basics in adverse event reporting as outlined in the WMDO course ‘adverse event processes (ID 59) is required before taking the courses in this suite. It is also useful to understand the mechanisms of ethics committee or institutional review board communications as outlined in course ‘Ethics Committee and IRB requirements (ID 46)