Enrolling new centres

List the documents that need to be sent to new centres and indicate where they can be found. These will include protocols, summary protocols, the completed local ethics committee application form (if required), a quality oflife pack (if relevant), a standard letter indicating the responsibilities of clinicians collaborating in the trial, and a centre accreditation checklist.

State whether a centre has to be visited by a member of the trials office team before randomizing patients and, if so, the purpose of the visit.

State whether clinicians' CVs are required and whether clinicians need to be registered with the regulatory authority - the Medicines Control Agency in the UK - before they start randomizing patients. In the UK, CVs are required if the trial involves a new unlicensed drug, or a drug used outside its licensed indications, and is being conducted under a Clinical Trial Certificate Exemption (CTX) held by a company or a Doctors' and Dentists' Exemption (DDX) held by a clinician who is not a consultant or adviser to a company (http://www.open.gov.uk/mca) [17].

Describe the conditions under which centres from abroad can participate.

Indicate whether other bodies, such as trial sponsors, should be given details of new centres. In the UK, the Medicines Control Agency has to be informed of new centres for trials conducted under a CTX or DDX.

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