Application and Maintenance of a CTA

The purpose of this SOP is to describe the procedures for applying for and maintaining a Clinical Trial Authorisation for Trials sponsored or co-sponsored by King‟s Health Partner Organisations in order to comply with UK Regulations and European Law.

The CTA submission package will be prepared and submitted by the KHP CTO CRA with collaboration from King's Health Partner Pharmacy Departments and the Chief Investigator Team as required.

SOP: Application and Maintenance of a CTA (3MB)

Related Documentation

REC Annual Progress Report Process Map(.ppt, 125Kb)

Related Templates

Annex 2 - Notification of Amendment (.doc 100Kb)

CT Form UK 1 (.doc 60Kb)

Declaration of End of trial form (.doc 50Kb)

KHP CTO amendment assessment form v5.0(.pdf)

MHRA Annual Safety Report Template (.doc 1250Kb)