I have now received these minutes. TSC: https://www.dropbox.com/s/1b86k0pvnymko16/TSC.zip?dl=0 TMG: https://www.dropbox.com/s/jhxmivxyn9k8lid/TMG.zip?dl=0 I am tired and have only skimmed through them. Major point is how little there is on the changes in protocol. TSC #8 File 20090429 TSC The TSC approves the PACE analysis strategy principles but will give extra time to TSC members to approve the PACE analysis strategy text. Action: to circulate an email to TSC members asking for comments by June. If no comments are received by that date it will be assumed that the relevant TSC member agrees with the analysis strategy. The analysis strategy will be presented to the Mental Health Research Network (MHRN) Methadology group on the 7th July. After taking the MHRN’s comments on board a TSC teleconference will be held to finalise the analysis strategy. During the teleconference it will be decided who will be responsible for signing of the analysis strategy. The data of the TSC teleconference will be decided by email. TSC #9 File 20100910 Joint meeting TSC and DMEC Presentation of statistical analysis for main paper presented an overview of the statistical analysis strategy for the trial. The changes made to the analysis since the original protocol was drafted were highlighted and it was noted that the analysis plan was agreed by the TSC and signed off before analysis commenced. ACTION 1: to ensure that the review and sign off of the analysis strategy by the TSC is well documented. And that was it. Notable that their constant reference to the approval by two independent committees is technically correct, but in practice the changes seem to have been made at a joint meeting of the two committees. Also interesting to me is how involved The Lancet was right from an early stage, and how the fast-track review was agreed before the paper was even written.