Joint Research Office


HRA invites researchers to feedback on CTIMPs protocol

26 January 2015

The HRA is inviting researchers to feedback on a protocol for use in Clinical Trials of an Investigational Medicinal Product (CTIMP) released for consultation.

Guidance and a template to help organisations and individuals to improve the consistency and quality of their CTIMP protocols have been developed.

The HRA says the use of the guidance and template is not mandatory and the documents are published as standards to encourage and enable responsible research by: supporting researchers developing protocols where the sponsor does not already use a template; supporting sponsors wishing to develop template protocols in line with national guidance; and supporting sponsors to review their existing protocol template to ensure that it is in line with national guidance.

Members of the research community are invited to comment until 31 May 2015.

To read more visit the HRA website.