Module 15 2022

20/05/2022

Types of Clinical Studies

Clinical Investigations generally fit into 2 main categories

Studies conducted Pre-CE Mark

Studies conducted Post CE-Mark

Previously the MDD, AIMDD and ISO14155 mainly provided guidance for Clinical Investigations of Pre-CE Marked devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

5

Clinical Investigation Design – Types of studies

STUDY

TREATMENT STUDIES Randomized Controlled Trial (RCT)

OBSERVATION AL STUDY

Prospective

Blinded

Cohort Study

Retrospective

Non-Blinded

Case-control Study Cross-sectional Study Ecological Study

Nested

Adaptive Clinical Trial

Non randomized Trial

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

6

3