...or Why I'm Not a Singing CRA.
During those confusing and wondrous years, when a young man ponders his career choices, my dream was to become a singer-songwriter. Blowing my hard-earned profits from an after school job on a multi-track recorder, I spent precious study time mixing down vocal, guitar and synthesizer tracks composing what would surely become the next big platinum album.
On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90), the latest rendition of the International Conference on Harmonization (ICH) Guideline covering the conduct of clinical research studies in the seven member nations. Guidelines represent the agency's current thinking on Good Clinical Practices, but do not bind the FDA or the public. However, most clinical research studies are now being conducted in compliance with this guideline, especially if the results might be used for an international regulatory submission. Here are the major differences.