Contraception

GCP Considerations: Contraception

Guidance on the recommended precautions when including men and women of child bearing potential in clinical trials, as well as, a consideration of the recommended birth control methods.

pdf/2011-03-12_GCP_Considerations_Contraception_(CHCUK).pdf

We routinely include statements in the clinical trial protocol and patient information leaflet/subject information sheet about potential harm to the unborn child and the need for use of a ‘reliable form of contraception’ during the clinical trial, but what do we mean by a ‘reliable form of contraception’?

The following short report walks you through the recommended precautions when including men and women of child bearing potential in clinical trials, as well as a consideration of the recommended birth control methods.

GCPThis report is intended to be a generic ‘considerations’ tool and therefore the reader should always abide by, and comply with, their applicable national regulations and guidelines and local policies and procedures.

Please click on the image above to download a complimentary copy of the GCP Considerations report on contraception in clinical trials.

Please note that you will need to a have a ‘PDF Reader ‘ installed to view the report.

Last Updated on: 12th March 2011

Reason for Update:

MHRA Guidance: Clarification of contraceptive wording in clinical trials conducted in the UK (May 2010)

Please contact us at info@chcuk.co.uk if you would like further information or guidance.