In Part One of this blog series, the definition of good source documentation and its importance was outlined. In Part Two, we look at the nature and causes of poor documentation, along with how these can be addressed.
Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation
was cited in 6 out of 10 warning letters issued by US-FDA to clinical investigators in 2010.
In many FDA warning letters, it can be observed that inadequate case histories, consent, adverse event recording, or drug dispensing and disposal records are often attributed to the lack of investigator’s supervision in ensuring compliance. The Principal Investigator (PI) delegates responsibilities to the study team and may not provide adequate time to review the source data due to lack of time and/or commitment. Study documentation is often left almost entirely on the shoulders of study coordinators.
Systematic deficiencies in documentation can lead to questions about data integrity, possibly leading to exclusion of such data by regulatory authorities. This in-turn means that the exposure of patients to new medicines and treatments, and the time, efforts and dollars spent by all those involved in the clinical research continuum, would be wasted.
Clinical research documentation involves a variety of documents from many sources and is often compiled and completed by multiple people. Moreover clinical research happens over a long period of time which increases the challenge of maintaining documentation continuity.
Principal Investigators should delegate responsibilities to staff adequately trained in protocol and Good Clinical Practice (GCP). Particular training should be provided on ALCOA (see Part I) and other good documentation practice requirements. Medical decisions should be delegated to medically qualified staff. Training of site staff should be repeated at defined frequencies. New hires should be adequately trained before trial participation. Clinical research sites should also develop a Standard Operating Procedure for good documentation.
Ultimately source documentation should speak for itself. It should outline the medical journey of the subject/patient as it happened to an independent observer (an auditor or inspector) and thus form a strong foundation for good clinical research.
The quality of documentation can make or break the study at a given site. It goes to the heart of Good Clinical Practice and is ‘The Eyes of Evidence’ for all clinical research.
Call our Clinical Development team on +61 3 9251 0777 to discuss how we can be of assistance to your study.
This article written by Ric DeGaris from our Clinical Development team.
To read part one of this blog series, click here.