Although there are no official regulations around the implementation of Good Documentation Practice (GDP), it is still considered a necessary and imperative requirement in the conduct of clinical trials.
Poor documentation is an issue that is frequently brought to light during investigator site visits/inspections and is often a result of lack of training and experience in Good Clinical Practice (GCP) amongst research teams. Therefore, it is vital that the importance of GDP, as well as GCP, is well understood and highlighted within clinical trials in order to ensure the integrity of a trial.
GDP plays a central part in the quality management of a trial. It is often said, ‘What is not documented, is not done!’, so as to emphasise the need to have every trial-related action and event recorded. Source documents, defined by ICH GCP 1.52 as ‘original documents, data and records’, should be accurate and adequate enough to be able to reconstruct the trial. There may not be regulations surrounding good documentation, however there are guidelines that should be followed to achieve it.
An example of a guideline detailing the essential characteristics of good documents/data (both paper-based and electronic) is the ALCOA principle.
Documents must be:
Documents/data must be clear as to who has generated and documented them and when. The initials of the individual and date are usually sufficient enough, if done manually. If done electronically, then this can be recorded via an audit trail. To be able to identify the signature/initials of the individual who completed the data/document, a signature log should be maintained as a reference.
Any signatures/initials and dates must be readable (legible) and identifiable. If corrections need to be made, a single line must strike the mistake in order to still be able to read it. If paper records are maintained, there should be ample space to record information.
The information should be documented in the correct time frame in accordance with the flow of events. If a clinical observation cannot be documented when made, then chronology of events should be recorded. Clocks on any electronic systems should also be synchronised.
This refers to the first record made by the appropriate person. The original document, also known as the source document, could be in a number of forms (i.e. notepads, loose papers, approved protocols etc.).
Nevertheless, it is vital that the original is recorded. If any information is hand-written and intended to be transcribed electronically, errors could occur and so it is imperative that the original source document is available to cross-check the information.
Source documents should be consistent and a real representation of the facts. Accurate records should be honest, error-free and complete. Any amendments that have been made must be documented, dated and initialled/signed. The accuracy of data and information should be thoroughly checked regularly to ensure minimum error.
Some very common errors regarded as poor documentation include, but are not limited to; overwriting digits, rushed record keeping, unsuitable and unreliable source document forms (i.e. loose papers, undesignated notepads, sticky notes etc.) and old data being blocked out or scribbled over without a date or signature/initial. In this case, where a mistake/old data has been blocked out, there are 3 inconsistencies with the ALCOA principle. This information/data is no longer readable, attributable or original.
Source documents should be easy to understand, read and complete. It is important to maintain and update versions of documents so that only one version is the current version. Any other versions should be superseded, dated and signed/initialled. The same applies to any approved amendments that are made, otherwise there is a risk that team members may not be using or complying with the correct information. For example, they could be following an old protocol or unaware of changes that have been made in relation to patient treatment.
Poor documentation is one of the greatest pitfalls during trial inspections and is an issue that needs to be acted on and addressed. By simply training staff to be more familiar and compliant with GCP and the appropriate guidelines set out to ensure good documentation, trials can be carried out more efficiently. Poor documentation can cost time, money and in some cases, patient safety.