Good Trials Practice
Standard Operating Procedures for Trials
For all trials there is a need to develop standard operating procedures (SOPs) that will be a guiding tool for professional conduct of the trial by all the participating departments/sections. The SOPs would follow Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Data Practice (GDP) as expected of a well designed trial and should be adhered to by staff attached to each department. With guidance from the trial principal investigator, and following what is written in the trial protocol, the head of each department/section would be charged with writing the SOP outlining the activities their department/section would carry out during the trial. The SOP should have a section indicating who wrote it, who approved it and the dates when it was written (or edited) and approved. It would then detail the objective of the section during the trial, the procedures to be carried out by department staff and the staff positions in department charged with all the different procedures. Once approved, the SOPs should be followed religiously. However instances when it is realized that there is a need to edit some procedures (includes any additions or subtractions) this should be brought by department/section staff to the attention of the PI (or designated individual) and a meeting during which changes and reasons for the changes are discussed. Once consensus is reached then these edits should be outlined in the last section of the SOP, with names and signatures of the person who edited and the one who approved, plus the dates when this was done. Remember that for monitored trials, SOPs would be the guiding tool to monitors and if not followed may lead them to decisions that may stop or delay implementation of the trial. A Guide to Developing SOPs for intervention trials from the Africa Centre for Health and Population Studies in South Africa is attached.