Information Links

Further information on all aspects of clinical trials can be found through the websites of the various groups below:

GCP Resources

R&D Office's & Research Links

Process Maps for when KCL / SLaM is Sponsor

Indicates the responsibilities of the KHP CTO, CTU and R&D Office for the management of sponsor responsibilities.

Non- Commercial

Commercial

Clinical Trial Applications

Medicines and Healthcare Products Regulatory Agency website
Governmental agency with responsibility for standards of safety and quality; ensuring that medicines and medical devices work and are acceptably safe.

EudraCT Database
EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC.

ISRCTN Register
Current Controlled Trials allows users to search, register and share information about randomised controlled trials.

IRAS
IRAS captures the information needed for the relevant approvals from the following review bodies:

  • Administration of Radioactive Substances Advisory Committee (ARSAC)
  • Gene Therapy Advisory Committee (GTAC)
  • Ministry of Justice (National Offender Management Service)
  • NHS / HSC research offices
  • NRES/ NHS / HSC Research Ethics Committees
  • Patient Information Advisory Group (PIAG)

Clinical Trial Conduct [UK]

Department of Health Clinical Trial Tool Kit
A site developed primarily for clinical trial investigators by the UK Medical Research Council and Department of Health. The site provides practical help in meeting the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.

NHS Legislation on Governance

Research Governance Framework 2nd edition 2005
The Research Governance Framework for Health and Social Care sets out the broad principles of good research governance. The first edition was issued in March 2001. The second edition was issued in April 2005.