In today’s world, pharmaceutical companies need to manage huge amounts of data over long periods of time, especially when conducting clinical trials. Is your system compliant with the latest legislation? Below, we cover the main rules and regulations that impact the way you store data.
It’s important to ensure that your data management system is always ready for GCP (Good Clinical Practice) inspections by the EMA (European Medicines Agency). These inspections aim to ensure the integrity and confidentiality of all clinical data, including clinical study reports and lab notes.
What can you do to make sure you pass an inspection?
- TMFs (Trial Master Files) must be complete upon inspection
- All supporting documents need to be in compliant systems
- Documents in the eTMF (Electronic Trial Master File) must be easily accessible
- All documents must be complete and contain all critical information
- System checks need to be in place to ensure that all processes are working
What could happen if you fail a GCP inspection?
- You may receive a critical finding, if your data is not ready for inspection
- You could be inspected again, shortly after your initial inspection, to see if there are any further
- issues and your CTAs (Clinical Trial Applications) may be suspended.
- You may receive an infringement notice
- There is a possibility that you could be prosecuted
eTMF data retention: The main rules
To make sure that you pass inspections, check that your clinical and eTMF data can be stored securely for 25 years, or for the lifespan of the product. Whatever the format may be, inspectors should be able to do the following:
- Search for the documents they need
- Easily identify the relevant documents
- See and review the audit trail and history of the associated documents
The ALCOA principle
The ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principle analyses your compliance with data integrity rules and regulations. As increasing numbers of pharmaceutical companies store more digital data, this principle has become extremely important in the industry.
So, what can you do to ensure that your data is complaint with the ALCOA principle?
- You must be able to show who acquired your data and performed any actions in relation to the data
- You must be able to access and read the data easily
- All original data must be available
- All amendments must be documented
- All data must be recorded, including any data referring to reanalysis
- All elements of the data must be accurately dated
- All data must be recorded in appropriate electronic or paper systems
- All data must be available for inspection
Do you have long-term access of your data under control?
Find out by joining our webinar, where we’ll be discussing eTMF Archives, GCP inspections and much more.
When does the webinar take place?
December 11th, 2019
3:30pm – 4:30pm GMT / 10:30am – 11:30am EST
How do I join?
Join by simply filling in our short form below.
08 Nov, 2019
Turn your research data from a liability into an asset
28 Oct, 2019
Good eTMF archiving practices…What do I need to know?
27 Apr, 2021