This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research.
This Month’s Subject—International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Did you know?
ICH E6 defines much of the terminology used in research?
“All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).”
“Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).”
Case Report Form
“A printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.”
For full text please see: