Klinisk prövning

**Textbook **”Fundamentals of Clinical Trials”, Springer 5th Edition, Lawrence M. Friedman”, Curt D. Furberg, Davis L. DeMets

• Chapter 1 “Introduction to Clinical Trials”
• Chapter 2 “Ethical Issues”
• Chapter 3 “What is the Question?”
• Chapter 4 “Study Population”
• Chapter 5 ”Basic Study Design”
• Chapter 8 ”Sample Size”
• Chapter 12 “Assessment and Reporting of Harm”
• Chapter 14 “Participant Adherence”
• Chapter 15 ”Survival Analysis”
• Chapter 21 “Multicenter Trials”

Links to Important Homepages regarding Clinical Trials:

Declaration of Helsinki

EudraLex - Volume 10 - Clinical Trials Guidelines

EudraLex - Volume 4 - GMP

EU Regulation No 536/2014 (Pharmaceuticals)

Q&A regulation 536/2014_EMA

EU Regulation 2017/745 (Medical device, MDR) (Effective from May 26 2021)

EU Regulation 2017/746 (Medical device, IVDR) (Effective from May 26 2022)

ICH E2A (Safety).

ICH GCP E6(R3) 2025.pdf

ICH E8 (General considerations)

ICH E9 (Statistics)

ICH E10 (Choice of control group)

ISO 14155:2020 (You will receive this document i Theme 2)

HSLF-FS 2021-109 (replaces LVFS 2011-19)-1

ClinicalTrials.gov - NIH/US

EU Clinical Trials Register - EMA

CITIS EMA (The new database in EMA since regulation 536/2014)

EU General Data Protection Regulation (GDPR)(Replacement of Data Protection Directive 95/46/EC)

Presentation materials in the form of videos, audio files and slides (in Canvas).