When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Perhaps the best acronym for guiding researchers through proper documentation is “ALCOA”. Having its roots in the federal regulations governing good laboratory practice for non-clinical laboratory studies, or 21 CFR 58.130 (15), “ALCOA” remains the practice of FDA auditors and quality assurance professionals regarding clinical practices.
To guide you through your research documentation, we’ve created a handy “go-to” sheet to help you with each point of “ALCOA”.
As research professionals, do you find this checklist helpful? Is there anything you would add to this list? As always, we’d love to hear your views!
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