ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data.
TABLE OF CONTENTS
1. GLOSSARY
3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
4. INVESTIGATOR
5. SPONSOR
6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
© European Medicines Agency, 2018
Clinical Research News
Upcoming Clinical Research Events
-
26 – 28 September 2023
Fierce Pharma
United States -
29 September – 01 October 2023
SOCRA (Society of Clinical Research Associates) -
Canada -
08 – 11 October 2023
TransCelerate BioPharma
United States -
08 – 11 October 2023
SCDM (Society of Clinical Data Management)
United States -
16 – 17 October 2023
The Conference Forum
United States -
17 – 18 October 2023
Cambridge Innovation Institute
Spain -
01 – 03 November 2023
RQA (Research Quality Association)
United Kingdom -
11 – 15 November 2023
AMIA (American Medical Informatics Association)
United States -
15 – 16 November 2023
World BI
United States -
29 – 30 November 2023
Informa
Spain
Připravované klinické studie
-
NCT06052852NáborClear Cell Renal Cell Carcinoma | Rakovina hlavy a krku | Kolorektální karcinom | Rakovina vaječníků | Triple negativní rakovina prsu | Nemalobuněčný karcinom plic
-
NCT06052826NáborMnohočetný myelom | B-buněčný non-Hodgkinův lymfom
-
NCT06051552Zatím nenabíráme
-
NCT06052020NáborPacienti s cévní mozkovou příhodou se symptomatickou intrakraniální aterosklerotickou stenózou
-
NCT06053515Zatím nenabírámeŽeny z rasových nebo etnických menšin
-
NCT06053268NáborLymfom | Leukémie | Dětská rakovina
-
NCT06052163Zatím nenabírámeAlzheimerova nemoc
-
NCT06053463Nábor
-
NCT06052293NáborExokrinní pankreatická insuficience
-
NCT06051916Zatím nenabíráme
-
NCT06051539Zatím nenabíráme