Knowledge Bank

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