This post is sponsored by IMARC Research, Inc.
Without a good working knowledge of Good Documentation Practices in clinical research, unintended consequences may occur. When it comes time for an inspection, it may be difficult to prove that the research process was being conducted properly without strong source documentation. This may manifest itself in illegible handwriting in a physician’s notes, missed details due to late entries of source, or an unclear audit trail to determine how, by whom, and when the data was obtained.
Year after year, one of the top three findings cited in FDA Warning Letters is failure to maintain adequate and accurate case histories (21 CFR 312.62(b) and 21 CFR 812.140(a)(3)).
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.
Fortunately, there is an acronym to help clinical research professionals remember the tenets of good documentation practices: “ALCOA.” Perhaps the best acronym for guiding researchers through proper documentation, “ALCOA” has 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”.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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!
