NNIT - From directive to regulation

Requirements for a study's trial master file are increasing. Part of an upcoming change is the demand for files being 'readily available' for inspection. Dorte Frejwald Christiansen from life sciences IT consultancy NNIT discusses how companies can prepare for the changing standards and increasing authority demands to ensure audit and inspection readiness.


Efficient clinical trials are a must and are a significant competitive factor in the process of bringing a product to market. As part of this, you have to ensure that all documentation associated with a particular study is well organised and accessible to investigators, sponsors and inspectors. And, of course, clinical trials must be conducted according to good clinical practice (GCP), or the documentation won't be accepted by the authorities and you will be set back, losing money for every extra day that the process is prolonged.

"GCP states that you should document everything you do during the trial, because you should be able to reconstruct the study," explains Dorte Frejwald Christiansen, life sciences consultant at NNIT, an international consultancy for IT in the life sciences industry.

As a result, studies produce vast amounts of documents and companies could find themselves with up to 25,000 files for each study that they need to store in an easily accessible way.

Make files readily available

The European Parliament has a directive that essential documents shall be archived in a trial master file (TMF) for a period of at least five years past the date of the completion of a trial. This directive is expected to become a regulation in May 2016.

One of the changes featured in the upcoming clinical trials regulation is the need to ensure that the TMF is readily available and accessible at all times. This is a tricky task, especially because many organisations rely to a high degree upon paper-based files.

Challenges of the hybrid TMF

Most companies have a hybrid TMF consisting of paper and electronic files. The paper-based documentation poses a challenge during authority inspections, particularly for multinational trials, as paper documents may be stored in several locations and not necessarily in the location in which the inspection takes place.

Ideally, an electronic document management system working as a hub for all electronic TMF-related processes would make it possible to enforce business processes and alignment with relevant guidelines, but, for as long as companies still have paper, this is not feasible.

"Very few companies have exclusively electronic filing and there are some requirements where you need to obtain a signature of a document. So, at this stage you cannot completely eliminate paper," says Frejwald Christiansen. "The focus right now is how to tackle the shift from directive to regulation and stay compliant."

The primary objective is to present the TMF in such a way that inspectors can easily find the required documents and possibly request paper-based documentation in case the inspection takes place in a location where these documents are stored. Rather than risk sending the files by mail, Frejwald Christiansen suggests sending certified digital copies of the original paper documents.

NNIT's TMF consultancy

According to Frejwald Christiansen, the coming years will clarify the implications of the regulation as we see examples of inspection findings, but, until then, companies should start preparing by analysing and mapping the relevant TMF content and deploying adequate actions to ensure they remain compliant.

Below, Dorte Frejwald Christiansen gives her top tips for preparing for the changing standards.

  • Companies must clarify the specific content of their TMF apart from the essential documents, as this depends on the individual company processes and trial setup; this is especially vital if they work with CROs.
  • Map out which IT systems hold the required information and the formats of the information.
  • Finally, companies need to develop a strategy on how to make the documents readily available regardless of IT system, format and geographical location.

To help companies handle the shift, NNIT is offering TMF consultancy to enhance the inspection readiness.

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