So, what exactly does it mean when we say ‘Good Documentation Practices’ and how do we put it into practice?This has become the commonly used phrase and become rather ceremonious in our clinical research conversations. The GDP term is often used the maximum during the site initiation visit (prior to study start) wherein the CRA makes it a point to ‘drill’ this acronym into the heads of the investigator, the CRC and the other delegated site staff. Why is documentation so important and why is ‘good’ documentation so crucially important in clinical research? ICH-GCP talks a lot about best documentation practices that ought to be followed by everyone involved in the clinical research study. Hence, obviously there is something serious about documentation of happenings in a clinical setting. Else, so much importance would have been uncalled for.

 

Any clinical research professional definitely understands the following phrases in depth:
‘If it is not documented, then it is not done!’
‘Document what is done first and also what has not been done!’

 

Often the most common findings or observations made by the CRA during his/her monitoring visits are related to lack of proper documentation. Though the site team would have been trained regarding the same repeatedly, yet there will be issues in this section. This does not show the ineptitude of the CRC or investigator, it is often a result of oversight or hurried work. Mostly the site teams keep the documentation work pending till they receive the monitoring visit intimation letter from the CRO. Only afterwards they hurriedly start completing the documents and hence result in a lot of errors.

 

The primary documentation involves in the management of the investigator site file (including all the study related logs), the source documents (medical records, hospital sheets, laboratory reports, efficacy questionnaires, etc.), the CRF entry and finally the most important the Informed Consent Process documentation. Well, it sounds pretty easy but a lot of effort has to be put in by the entire team to achieve GDP.

 

The best way to get things done is by following the ALCOA method. The vital attributes for GDP were first given by the US-FDA as ALCOA – which is an acronym that stands for Attributable, Legible, Contemporaneous, Original and finally Accurate. Later on, considering the efficacy of this method, these are also quickly adapted by the World Health Organization as well. These criteria have evolved ever since and currently EMA has added, or rather contributed, some more ‘letters’ to ascertain GDP particularly keeping in mind the electronic documentation practices.

 

ALCOA:

Attributable: Yes, the data generated should be attributed to a specific person who is delegated in the study by the Principal Investigator. It is also important that ONLY the delegated person enter the data.

Legible: Yes, we do know the cliche ‘Doctors have a bad hand-writing’. However, when it comes to Clinical Research, the entries made by the investigator or his/her team in any of the trial related documents should be legible to make sense out of it.

Contemporaneous: Another important factor. All data entered should make chronological sense. This is very important when it comes to trial related activities and the illogical flow of events form the crux of major findings during an inspection or audit. The data should be entered as soon as possible after completion of the activity.

Original:The authenticity of the data should be verifiable with the original source document. Wherever possible the original documents should be made available and if this is a challenge in some scenarios, then at least a photocopy from the original should be placed.

Accurate: This is another important factor. The data entered should be consistently accurate and should reflect the actual representation of the activities as they took place. The facts of the scenario must be accurately described.

 

There are a few more criteria that have been included which are rather self-explanatory such as Enduring, Complete, Consistent, Credible and Corroborated. This is a summary of best documentation practices but always remember there is no such thing as ‘perfect documentation’. The idea is to get better and better at documentation as far as possible, as often as possible and as good as possible!