Table 1

 Summary of the approvals process

Type of approvalBody granting approvalDate when the approvals process beganDate of submissionDate granted
*Clinical trials authority certificate application requires sponsorship approval before submission.
Research governanceBradford South and West PCT8 November 20042 December 200420 December 2004
EthicsMREC Northern and Yorkshire11 January 20053 February 20055 July 2005
SponsorshipUniversity of Leeds11 March 200511 May 200528 June 2005
Clinical trials authority certificate*Medicines and Healthcare Products Regulatory Authority11 March 200511 July 200528 September 2005
International standard randomised controlled trials number www.controlled-trials.com 27 June 200516 August 200515 September 2005 (backdated to 16 August 2005)