Interestingly, inadequate and/or inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites, while in Europe, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites (2009 finding).
The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide an audit trail to permit investigation if and when required.
Source documentation records the progress of the trial subject from consent through till the subject completes the study. It forms a strong foundation for the data that gets transcribed into a Case Report Form (CRF), which ultimately gets translated into a clinical study report.
Remember – What is not documented is not done.
Irrespective of the clinical trial, accurate documentation supports the fundamental principle of protecting a subject’s rights, safety and well-being.
So, what does it mean when we say ‘Good Documentation’?
Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined. Key attributes for good documentation were initially described by US-FDA: attributable, legible, contemporaneous, original and accurate (ALCOA). These have also been adapted by the World Health Organization (WHO) and the European Medicines Agency (EMA), who have added further letters particularly for electronic documentation.
It should be clear who has documented the data.
Readable and signatures identifiable.
The information should be documented in the correct time frame along with the flow of events. If a clinical observation cannot be entered when made, chronology should be recorded. Acceptable amount of delay should be defined and justified.
Original, if not original should be exact copy; the first record made by the appropriate person. The investigator should have the original source document.
Accurate, consistent and real representation of facts.
Good documentation also needs to be enduring, available and accessible, complete, consistent, credible and corroborated.
These are the expectations of clinical trial source documentation, however in reality, many issues are observed in terms of the quality of source documentation. For more on these issues look out for part two of this blog series.
Our Clinical Development team can help to ensure that your clinical trial source documentation meets the standards required. Call us on +61 3 9251 0777.
This article was written by Ric DeGaris from our Clinical Development team.