Privacy compliance vs assurance in clinical trials: Why you need both

Clinical Research Organisations (CROs) are increasingly asked to demonstrate privacy assuranceDemonstrating that privacy controls operate effectively in practice through testing, monitoring, audits, or independent assessments through recognised frameworks and certifications. For teams already navigating multiple regulatory requirements, this can quickly feel overwhelming. 

Whilst compliance with laws such as the EU and UK General Data Protection RegulationRegulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). (GDPR) or the US Health Insurance Portability and AccountabilityPerhaps the most important GDPR principle, which requires controllers to take responsibility for complying with the GDPR and, document their compliance. Act (HIPAA) remains essential, sponsors, partners, and regulators are now also looking for evidence that privacy and security controls operate effectively in practice. 

This blog, based on insights from our recent webinar FULLY ASSURED: Getting privacy and assurance right in clinical trials, explores the difference between privacy complianceMeeting applicable data protection laws and regulations by implementing appropriate technical and organisational measures to enable lawful data processing and assurance. We examine how gaps can affect clinical trial operations and provide practical steps you can take to strengthen your assurance approach. 

• What’s the difference between compliance and assurance? 
• How compliance gaps appear in clinical trials   
• Making sense of assurance frameworks 
• Strengthening privacy assurance in clinical trials 
• Frequently asked questions 

What’s the difference between compliance and assurance?

Privacy compliance focuses on meeting legal and regulatory requirements. For organisations involved in clinical trials, this typically means demonstrating alignment with laws such as the GDPR in the EU and UK, HIPAA in the US, or other local data protection legislation.  

In practice, this includes activities like identifying lawful bases for processing personal dataInformation which relates to an identified or identifiable natural person., completing Data Protection Impact Assessments (DPIAs), and implementing appropriate safeguardsWhen transferring personal data to a third country, organisations must put in place appropriate safeguards to ensure the protection of personal data. Organisations should ensure that data subjects' rights will be respected and that the data subject has access to redress if they don't, and that the GDPR principles will be adhered to whilst the personal data is in the....  

Privacy assurance goes one step further. It focuses on demonstrating that those controls operate effectively in practice.  

Assurance can come from internal governance and audit activities, such as testing privacy controls or monitoring how policies are implemented across teams. It can also come from independent external assessments, such as SOC 2 reports, HITRUST certifications, or ISO 27001 audits. 

How compliance gaps appear in clinical trials 

Delays linked to privacy and compliance rarely arise because organisations are unaware of regulatory requirements. More often, challenges emerge when teams are uncertain how those requirements should be interpreted, applied, or demonstrated in practice. 

For clinical trial teams, this can result in: 

• Contracts or Data Processing Agreements (DPAs) becoming stuck in review 
• Ethics committees requesting clarification on transparency and accountability 
• Inconsistent answers to due diligence questions 
• Expansion into new regions exposing undocumented practices 

When organisations are unable to evidence their controls, stakeholders may need to conduct deeper checks or request additional documentation. This can slow onboarding, procurement processes, or trial approvals. 

Mature assurance practices help reduce this friction. By clearly documenting, testing, and independently validating controls, organisations can respond to the above scenarios more efficiently and give sponsors, partners, and regulators greater confidence in their processes. 

Making sense of assurance frameworks 

Whilst regulations such as the GDPR and HIPAA set expectations, they do not prescribe exactly how organisations should structure their security and privacy controls. Assurance frameworks solve this by providing structured ways for organisations to demonstrate that appropriate controls are in place and operating effectively. 

Different frameworks serve slightly different purposes. For example: 

• ISO 27001 focuses on establishing and managing an information security management system 
• HITRUST is widely used in healthcare and maps security controls to regulatory requirements, such as HIPAA 

Choosing the right assurance framework  

The most appropriate assurance framework will often depend on factors such as location of the trial, what types of data are being processed, and what sponsors or partners expect during due diligence. 

When deciding which framework to prioritise, organisations should consider several practical factors, such as: 

• Regulatory environment: Choose a framework that aligns with the regulatory regimes governing your operations 
• Market expectations: Consider whether sponsors, CROs, or partners expect recognised certifications or audit reports, such as SOC 2 
• Scope of operations: Organisations operating globally may benefit from widely recognised frameworks, such as ISO 27001 
• Organisational maturity: Select a framework that matches the maturity of your organisation’s governance and control environment 

Ultimately, the objective is not to pursue multiple certifications simultaneously, but to establish a structured control environment that can demonstrate compliance across in-scope jurisdictions, regulatory frameworks, and contractual models.  

Strengthening privacy assurance in clinical trials

Taking a structured approach can make it easier to demonstrate strong privacy assurance. Here are the main areas to consider: 

Understand your regulatory drivers 

Before pursuing certifications or assurance frameworks, it is important to clearly understand the relevant regulatory and contractual obligations. This includes identifying where trials are running, what types of data are being processed, and what sponsors or partners expect as part of vendor due diligence. 

Clarifying these drivers early helps ensure any chosen assurance frameworks align with real operational and regulatory requirements. 

Build controls with evidence in mind

When implementing data protection policies and procedures, consider how those controls would be demonstrated to an auditor or partner. Designing processes with testing, documentation, and regular review mechanisms from the outset can make future assurance activities far more efficient. 

Centralise your privacy management system

Fragmented compliance activities across departments can create inconsistencies and make it difficult to demonstrate oversight. Aligning GDPR, HIPAA, and security control requirements within a single, structured privacy management system, such as HITRUST, can help create a more consistent framework. 

In practice, this may include maintaining a centralised Record of Processing Activities (RoPA), documented data flows, and clearly defined governance structures that allow privacy, compliance, and security teams to work from the same framework. 

Prioritise high-risk areas 

Not all controls carry the same level of risk. Focusing assurance efforts on high-risk areas — such as patient-level data, cross-border transfers, and critical vendors — can help organisations address the most significant challenges first.  

A risk-based approach ensures resources are directed where failures would have the greatest impact on patient privacy, regulatory compliance, or trial operations. 

Treat assurance as an ongoing discipline

Certifications and audits should not be viewed as a one-time exercise. Mature programmes include regular control testing, periodic reviews, and reporting mechanisms that support continuous improvement. 

Embedding assurance into ongoing governance processes helps demonstrate sustained compliance rather than preparing reactively for individual audits. 

Frequently asked questions 

Do organisations need assurance frameworks if they are already GDPR compliant? 

Ideally yes, although this is not a mandatory requirement. GDPR compliance establishes the legal framework for processing personal data, but it does not by itself provide independent evidence that security and privacy controls are operating effectively. Assurance frameworks and certifications can help organisations demonstrate this to sponsors, regulators, and partners. 

Which assurance framework is most relevant for clinical trial organisations? 

There is no single framework that suits every organisation. The most appropriate approach will depend on factors such as the jurisdictions in which trials are conducted, the types of data processed, and sponsor or partner expectations. Frameworks such as ISO 27001, HITRUST, and SOC 2 are commonly used to demonstrate assurance. 

Are assurance certifications required to demonstrate strong privacy governance? 

Not necessarily. Organisations can demonstrate assurance through internal governance processes, such as control testing, audits, and monitoring. However, independent certifications or audit reports can provide additional confidence to external stakeholders. 

When should organisations start thinking about privacy assurance in a clinical trial? 

Ideally, assurance considerations should be addressed early in the trial or procurement lifecycle. Embedding strong controls, documentation, and governance processes from the outset makes it easier to demonstrate compliance during the due diligence, onboarding, or regulatory review stages. 

The DPO Centre supports organisations in strengthening privacy assurance and demonstrating effective data protection governance. Contact us to discuss how our team can support your organisation. 

For organisations seeking specialist assurance and certification support, IS Partners also provide expertise in SOC reporting, HITRUST, and other assurance frameworks. 

In case you missed it…

• Clinical trials and GDPR: 5 common misconceptions and how to overcome them 
• Europrivacy certification for GDPR compliance 
• Privacy Management Platforms: A practical guide for strengthening privacy operations