How to Apply a Risk Based Approach to Records Management

The European Medicines Agency (EMA) has recently published its final reflection paper on risk based quality management in clinical trials, reference EMA/269011/2013, 18 November 2013.The management of trial records is barely mentioned in the paper but I took away a few principles that could be applied to clinical records management. Please note that, as always, these are my own personal views and do not ncessarily represent the viewpoint of the EMA!

The paper says:

“The current manner in which some elements of a quality system are implemented by sponsors and their agents (CROs etc.) is generally acknowledged to be time-consuming and constitutes a major proportion of the cost of development of medicines. In addition, the ICH GCP guideline was finalised in 1996 when clinical research was largely paper based, but the available technology and the approach to the conduct of clinical trials has evolved considerably in the meantime.”

I liked the fact that ther EMA is acknowledging the short-comings of the ICH guidelines with respect to its application in the 21st century. We need to be identifying more opportunities to introduce process efficiencies and avoid the temptation to use regulations as an “excuse” to be overly cautious. The EMA consider industry to be generally risk-averse, stating:

“Current practices in clinical research are not proportionate to risk nor well adapted to achieving the desired goals. The origins of the problem are multifactorial and include: risk aversion – society and its institutions (public and private) is increasingly risk averse, often with little appreciation of the actual or relative risk of different activities, leading to imbalanced or disproportionate risk mitigation”. The rsflection paper then goes on to say:

“Since perfection in every aspect of an activity is rarely achievable or can only be achieved by disproportionate allocation of resource, it is necessary to establish a risk based quality management system for which the ultimate principles are reliability of the trial results and the well being and safety of trial subjects. This system is based on identification of trial priorities and mitigation of the significant and serious risks and establishing tolerance limits within which different processes can operate.”

What this is saying to me is that we need to identify and assess the risks involved in developing processes for managing trial master file content but we then need to manage those risks in the light of all of the other risks involved in running a clinical trial, most of which have a much greater impact on the well-being and safety of trial subjects. We tend to put far too much effort and resource into developing high-quality records management processes and systems when perhaps that level of resource is not justified.

Don’t get me wrong, I’m not suggested we simply “lower the bar” and aim for poor quality systems and proceses but that we carry out a proper risk assesment when we “do” process re-engineering. And the EMA support this, recommending that we conduct a “Risk assessment requiring knowledge and understanding of what really matters for the establishment of priorities and the identification of risks: what may go wrong? What is the probability (chance/likelihood) of the occurrence of a negative outcome? What, in particular, would be the impact on trial subjects’ rights/well-being/safety and/or on the reliability of the trial results?”.

So let’s take as an example the required level of QC necessary when scanning a paper document, importing the PDF into an eTMF, indexing the electronic file and deciding whether to keep or destroy the original paper document. Is the process we define proportionate to the risk? Will errors likely result in an adverse effect on subject well-being and safety? Are there opportunities for errors to be mitigated against. Let’s have a “reality check” and ensure we’re taking a reasonable risk-based approach with records management as well as for trial conduct and study monitoring.

About Rammell Consulting: We are a specialist records management consulting company, providing a range of consultancy, training and education services to the life sciences/healthcare sector. Please refer to our website for further information.


About rammellel

Records management consultant to the life sciences / pharmaceutical industry
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