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Trial Summary Various languages

Protocol

Various languages

1. Background

Background

Dose selection

2. Study Design

Summary

Trial size

Eligibility

Consent

Randomisation

Study treatment

Serious Unexpected Suspected Adverse Events (SUSAR)

Expected side effects

Unblinding

Measures of outcome

Analysis

3. Organisation

Data monitoring and ethics committee

Steering committee

Collaborators' responsibilities

Co-ordinating centre responsibilities

Publication

Indemnity

Financial support

4. References

Forms & Procedures

Patient entry form

Outcome form

Patient and Relative Information Sheet

Legal Representative Consent Form (European Union only)

Procedure for obtaining Consent (European Union only)

FAQ Taking Part | Enrolling patients | Organisational issues
Collaborators Hospitals with ethics approval, listed by the country
Newsletters Spring 2005 | Summer 2005 | Autumn 2005 | Winter 2006
About us Trial management; Data; Administration; School; Department; Unit
Contacts

Enquiries and study materials
Co-ordinating Centre and management group

Information for patients Study Co-ordinating Centre; Information about the trial; Useful organisations
Other Information & links Clinical trials in the UK | Drug regulatory authorities by the country | Cochrane Injuries Group | European Society of Anaesthesiology ESA | PowerPoint presentations: Scientific, Practical Aspects | ICH GCP | Patient Information Leaflets in various languages