RK Statistics
  • Home
  • About RK Statistics
  • Consultancy
  • Training
    • Training for Non Statisticians
    • Training for Statisticians
    • Online Courses
  • IDMCs/DSMBs
  • Knowledge Bank
  • News
  • Contact

Knowledge Bank


​​List of the main guidance documents provided by ICH, CHMP for Europe and FDA for the US that contain statistical content.
Regulatory Guidelines:

Below you can gain access to the main guidance documents containing statistical content from the ICH (International Committee on Harmonisation), EMA (European Medicines Agency) through the CHMP (Committee on Human Medicinal Products) and the FDA (Food and Drug Administration). Many of the therapeutic area specific documents also have things to say about statistics.
These documents can also be obtained from the EMA and FDA websites.
​
Other Guidance Documents:

There are a number of groups that have produced useful guidance in particular for structuring publications.

The CONSORT statement concerns the reporting of clinical trials.
www.consort-statement.org

PRISMA is a similar statement focussed on the reporting of meta-analyses.
www.prisma-statement.org

STROBE is a statement relating to the publication of results from observational studies.
www.strobe-statement.org

​
International Committee on Harmonisation - Documents
A selection of documents from the International Committee on Harmonisation (ICH).
Read more...


​Committee on Human Medicinal Products - Documents
A selection of documents from the Committee on Human Medicinal Products (CHMP).
​Read more...

Food and Drug Administration - Documents
A selection of documents from the Food and Drug Administration (FDA)
​Read more...
​Contacting RK Statistics
​Brook House,
Mesne Lane,
Bakewell DE45 1AL, UK
Registered in England & Wales No. 6934610
Telephone: +44 (0) 1629 810093
Mobile: +44 (0) 7917 322603
Email: richard.kay@rkstatistics.com

​RK Statistics © 2021 All rights reserved
Site powered by Wish Cloud Ltd
  • Home
  • About RK Statistics
  • Consultancy
  • Training
    • Training for Non Statisticians
    • Training for Statisticians
    • Online Courses
  • IDMCs/DSMBs
  • Knowledge Bank
  • News
  • Contact