Data protection and clinical regulatory compliance are everyone’s responsibility and need a team approach. Responsible organisations train their management and clinical teams in data privacy and protection, empowering them to play their part while demonstrating the organisation’s commitment to carefully handling all personal data.
For those that do not see the difference between data privacy and protection, here is a good description: Data privacy defines who has access to data, while data protection provides tools and policies to restrict access to the data.
Complying with the GDPR is a multifaceted undertaking. Knowing where to start and what the priorities are is half the battle. But often, when resources are limited, and the focus is on updating policies and procedures while also planning for your first clinical trial in Europe, data protection and privacy training falls off the radar.
Data breaches still happen even with the most robust policies, systems and procedures in place. But why is this? Considering that around 80% of data breaches involve a human element, it’s no wonder that human error is one of an organisation’s most significant data security risks. Therefore, empowering your employees to adopt data protection and privacy best practices in everything they do will help mitigate the risk. Data privacy and data protection training should be integral to your compliance strategy.
This article discusses what the regulations say about data protection and privacy training, who should receive training and the benefits to your organisation of raising awareness among your staff.
What do the EU GDPR and UK GDPR say about training?
Both regulations make little mention of ‘training’. The clearest example is from Article 39, which discusses the role and responsibilities of the Data Protection Officer and states:
‘the data protection officer shall…monitor compliance with this Regulation…[through] awareness-raising and training of staff involved in processing operations’
and Article 47 requires ‘the appropriate data privacy and protection training [for] personnel having permanent or regular access to personal data’.
However, rather than focusing on how often the GDPR mentions ‘training’, companies should be looking to their obligations under the GDPR’s Accountability Principle, particularly data privacy by design.
Data privacy by design is where data protection and privacy become part of the organisation’s culture by adopting an organisation-wide approach to data protection and embedding privacy considerations into any processing activity you undertake. To fully achieve this, your employees must understand the general principles of the law and how to apply them in practice. They need to feel empowered to take responsibility and confident in reporting issues internally should they arise.
Who should receive data protection and privacy training?
The GDPR has a broad scope, and thus it’s likely that at least 90%, if not all, of your employees are processing personal data to fulfil their role. In addition, as a research organisation conducting clinical trials, some of your staff will be processing special category data, e.g., health data.
Anyone working in drug/device development clinical trials, from managers to site staff, should receive data protection/GDPR data privacy officer training. It’s also crucial that those who with a role in data protection or information security receive regulation-specific training, especially if they have limited experience with the EU or UK GDPR and how they apply to your organisation and in the context of clinical trials.
Roles seeking GDPR training may include:
- Pharmaceutical/biopharmaceutical/device managers and directors working in GxP areas
- Clinical Research Managers, VPs and Directors
- Quality Assurance for clinical trials /GxP
- Clinical trial site staff
- Contract Research Organisations and other vendors working on clinical trials
- Data management personnel
- Pharmacovigilance for clinical trials
- Information security managers
- Data Protection Officers
- IT and corporate security managers involved in GxP areas of drug development
- Corporate governance managers responsible for clinical trials
- Risk and compliance managers responsible for clinical trials
- Internal legal teams with responsibility for clinical trials
What are the benefits of data protection/privacy training for a pharma/biotech business?
GDPR data privacy training for your staff helps you demonstrate data protection/privacy regulatory compliance under the Accountability Principle, but its benefits go much further than that and include the following:
- Reducing your risk of fines and sanctions.
- Reducing your risk of personal criminal prosecution.
- Reducing human error
- Increasing productivity and efficiency of data processing/working practices
- Saving you time, resources and effort in data collection and logging processes
- Demonstrating mitigating circumstances should a data breach occur
- Conducting trials with greater confidence
Are you looking for a data protection consulting service that can tailor GDPR data protection/privacy training to the needs of management and clinical trials teams in your pharma or biotech business?
Perhaps you don’t have the in-house resources for training, or your expertise lies in data privacy in the US, Canada or other non-European countries, and you need help applying the EU or UK GDPR.
Our specialist team has extensive European pharmaceutical data protection and privacy knowledge and experience. We provide data protection and privacy training tailored to the needs of your team to help them navigate the legal intricacies of the GDPR and apply them to pharma and biotech working practices.
Pharma Data Protection – our data protection/GDPR data privacy officer training:
- Explains EU and UK GDPR data protection and data privacy legislation and how GDPR applies to your research organisation and clinical trials (including special categories of personal data)
- Explores the role of management and clinical research professionals in data security and their responsibilities in achieving and maintaining organisational GDPR compliance
- Shows you how to adopt good working practices to ensure GDPR compliance – including policies, procedures, risk assessments, audits, and reporting processes
Once trained, every member of your organisation becomes the eyes and ears of data security. With everyone onboard, the effort is shared, and you will see consistency in applying data protection/privacy practices – thus mitigating the risk. In addition, data processing becomes more efficient, saving you time and resources.
Talk to us about your Data Privacy Training needs