“All good things come to an end” – and so do clinical studies. A lot of activities will run in parallel when the clinical part of a study – the recruitment and treatment of study participants – is over. The orchestration of these activities by an experienced project manager is as important as the professional preparation of any archiving activities. It is worth remembering that the archiving duration will depend on the type of clinical study that you conducted. While the documentation of recent clinical drug trials in Europe at the sponsors and investigational sites must be archived for 25 years, different periods may apply in other parts of the world. For clinical studies with medical devices or other interventions, the retention period might be shorter.

Key considerations for sponsors:

A symphony of activities

When the database of your clinical trial is complete and the data analysis approaches, there might be a tendency to concentrate on what is to come: Are the results satisfying, and do they meet the expectations? It is recommended that the following activities are started early during the final study phase so that they do not interfere with the database closure activities:

• Data cleaning: Continuous data cleaning keeps pressure from investigational site personnel and helps keep the timelines.
• Quality issues: Monitoring issues should be closed when database lock approaches. Site audits or other in-process audits need to be scheduled with care: An audit might discover issues that have not been seen before and that affect more than just a single site.

Preparation for archiving

At the end of the trial period, the essential documents need to be prepared for the archive – at the sponsor as well as the investigational sites. Nowadays, the usage of electronic Trial Master Files is increasing. It is tempting for a sponsor to use the high-end eTMF solution that the chosen CRO offers. However, the sponsor needs to be aware that if they do not use the same system, the archiving of the sponsor data will be with the CRO for the coming decades. A migration to another system that the sponsor might use will be connected to good preparation, system validation, and quality checks.

Interested to know more about trial activities & study archiving? Contact us today for a consultation and find out how we can help in supporting your trial.

Autor: Dr. Christoph Ortland, Feburary 2024