Standard operating procedures

Trials centres should develop standard operating procedures (SOPs) that state the general principles adhered to by the centre in conducting its research programmes and provide general instructions on the conduct of trials. They thus establish a scientific and administrative policy applied across all trials, ensuring a high level of efficiency in working practices, greatly assisting the training of new staff, and enabling staff members to take over others' trials with minimum disruption. SOPs will obviously differ between centres in detail and in the way they are organized and set out, but the general topics and the principles should be very similar from centre to centre.

Typical SOPs cover many of the topics dealt with in this book, including trial conduct, grant applications, costings, protocol design, informed consent, contracts between industrial and non-industrial partners, ethics committees, collaborators' responsibilities, data management, and publication. They should be kept under constant review and updated as often as is necessary.

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