After the world celebrated Data Privacy Day this past weekend, Clinical Trials Arena will be shining a spotlight on data management as part of January’s ‘Data Strategies Week.’ With the General Data Protection Regulation (GDPR) fast approaching, we will look at the biggest issues surrounding patient data collection.
Be sure to visit CTA later today when Diego Herrera of Almirall explores the trends in clinical data management and how its role has evolved. We also have a feature from Jyotsna Mehta (Keva Health), who examines real world data and how to solve the industry’s big data problem.
Later in the week, Terry Katz (Merck Animal Health) looks into the use of clinical analytics software and how they can improve study processes.Additionally, CTA Editor Henry Kerali will provide four considerations for companies as they prepare for GDPR’s implementation. So as you can tell, a full range of topics will be given the spotlight on CTA this week, so don’t miss out!
But first, catch up on some of CTA’s most recent stories delving into the challenges concerning data management… (click on the headline to finish reading).
Henry Kerali provides a checklist of five key things you need to know about EU GDPR
1) What is GDPR?
Essentially, the EU General Data Protection Regulation (GDPR) supplants the previous Data Protection Directive 95/46/EC, a formal set of guidelines concerning data privacy. The premise of the new regulation is to bring into line data privacy laws throughout Europe, while safeguarding the rights of EU citizens. Crucially, the GDPR aims to alter the way organizations handle and process sensitive data. The regulation is set to come into effect in May 2018.
The EU rules on data protection seek to protect individuals by placing restrictions on the processing (collecting, storing or using) of their personal data. Under the new General Data Protection Regulation 2016/679/EU (“GDPR”), which will apply throughout the EU from May 25, 2018, these rules have been strengthened: data subjects have new rights to help ensure their data are processed securely and with adequate protections, and clearer responsibilities and obligations are placed on companies using such data.
The purpose of trial monitoring is to ensure the rights and wellbeing of human subjects are protected, and the reported trial data are accurate, complete and verifiable from all source documents. To achieve this purpose, the monitor has nearly 20 tasks (as defined by ICH E6 GCP1), including but not limited to source data verification (SDV). For decades, 100 percent SDV was deemed by pharma as the most effective procedure for achieving high quality data, despite the fact this practice was neither requested by the regulators (and/or applicable guidelines) nor proving effective.
Data are the elements that comprise the outcome of a clinical trial. A long time ago data was collected on pieces of paper, with scribbles and cross-out, supplemented with initials and dates. Pharmaceutical development tightened their processes and evolved into today’s galaxy with limited-access databases and remote entry. The industry generally retained the core quest for “truth” by monitoring against the stored hospital records. This time-honored tradition was finally shaken by TransCelerate with a subsequent reduction in source document verification, replaced by remote monitoring for oddities and inconsistencies.