ABSTRACT
Just as standard operating procedures (SOPs) are required as infrastructure, so is training of staff, or perhaps more significantly, documentation of that training. Training is listed explicitly in the regulations, as we see in the International Conference on Harmonization (ICH) document “E6 Good Clinical Practice: Consolidated Guidance” which states: “2.8 — Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” 21 CFR 11 echoes this in section 11.10, which states that the procedures and controls related to maintaining electronic records will include: “(i) Determination that persons who develop, maintain, or use electronic record/ electronic signature systems have the education, training, and experience to perform their assigned tasks.”
