Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations.They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.
Over the last fifteen years, the FDA published several guidance documents to help the clinical research industry shift toward electronic document management.
Perhaps failure to appreciate the wisdom contained in the quotes below explains why those doing clinical research spend a lot of their time on non-productive activities.
There is broad agreement across the pharmaceutical industry that it no longer makes sense to collect clinical trial data by writing results and observations first on a piece of paper, then to transcribe those data into an EDC system, and then to save that paper so that a clinical research associate (CRA) can check how precisely a person transcribed information from a piece of paper into the EDC system.
This standard is also generally a worldwide requirement for the conduct of clinical trials submitted to other regulatory authorities.
The guideline includes the requirements for records, how these are to be kept and the conditions under which they are to be made available for monitoring, auditing and inspection.