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.
"ALCOA-C" remains the practice of FDA auditors and quality assurance professionals regarding clinical practices. This checklist reflects the recently updated guidelines (ICH GCP E2 Rev2) and how clinical research professionals should apply them to their study. Simply fill out the form to get the guide!