Clinical Trial Compliance: Protecting Data and Participants in 2025
Clinical trial compliance refers to the strict adherence to ethical principles, regulatory requirements, and Good Clinical Practice (GCP) guidelines at every stage of a study, from protocol design to data collection, processing, to reporting. Its objective is twofold: protecting participant rights, safety, and dignity, and ensuring the scientific validity and regulatory acceptability of trial data.
Yet, despite comprehensive guidelines, high-profile malpractices such as patient-recruitment fraud and deliberate data fabrication still emerge, undermining trust and carrying severe legal and reputational repercussions.
These lapses highlight the critical role of strong regulatory frameworks and data-protection laws most notably the GDPR’s Article 5 principles of lawfulness, purpose limitation, and data minimization. It emphasizes on preventing misuse of sensitive health information and enforcing accountability from day one.
In this blog, we’ll define clinical trial compliance, map out the key regulatory bodies and frameworks involved, and explain how GDPR requirements intersect with Good Clinical Practice. We’ll then tackle common compliance challenges, share best practices for keeping trials on track, and explore the important role of the Data Protection Officer (DPO).
Compliance in clinical trials involves more than paperwork – it means embedding regulations and ethics into every aspect of a study. At its core, clinical trial compliance is about following all applicable laws (for example, FDA, EMA, and MHRA regulations) and guidelines to protect study participants and data. The approach to ensure the safety and protection of participants and their data includes rigorous informed consent processes, secure data collection, and transparent reporting.
According to the FDA, Good Clinical Practice (GCP) establishes the ethical and scientific quality standards that govern how clinical trials are designed, conducted, and reported, ensuring that participant welfare is the top priority and that the data generated is reliable and verifiable
In practice, that means informed consent forms must clearly explain risks and data use, protocols must be followed, and subject data must be handled securely.
Clinical trials are governed by multiple overlapping authorities. Below is a breakdown of the major authorities and standards that govern clinical trial compliance:
The FDA regulates clinical trials in the United States under Title 21 CFR to protect participant safety and ensure data integrity. It sets standards for electronic records and signatures (Part 11) and defines requirements for informed consent (Part 50) and IRB oversight (Part 56).
The EMA enforces Regulation (EU) No 536/2014, which harmonizes trial approval, conduct, and transparency across all EU member states via a single submission portal (CTIS) and mandates public disclosure of results in the EU Clinical Trials Information System.
Since Brexit, the MHRA governs UK trials under the UK Clinical Trials Regulations, managing authorizations through the Integrated Research Application System (IRAS) and applying ICH guidelines for clinical trials adapted for UK law.
The ICH E6 (R3) guideline provides globally harmonized standards for trial design, conduct, recording, and reporting, emphasizing a risk-based quality management approach and the protection of participants’ rights, safety, and well-being.
The EU GDPR and UK GDPR apply to all processing of personal and pseudonymized health data in trials, mandating lawful processing, fairness, transparency, data minimization, and data protection by design. If you want to process or utilize sensitive health information, it becomes crucial to comply with the GDPR.
Japan’s PMDA oversees clinical compliance under the Pharmaceutical and Medical Device Act, conducting scientific reviews of trial protocols and GCP inspections to ensure the safety, efficacy, and quality of investigational drugs and devices.
Health Canada regulates clinical drug trials through the Food and Drugs Act and related regulations, issuing guidance on trial applications, ethics approvals, and safety reporting to safeguard Canadian participants and maintain data quality across all phases of research.
Privacy regulations like the GDPR play a central role in modern clinical research compliance. Clinical researchers must incorporate GDPR principles at every step. Article 5 of the GDPR lays out key data standards: lawfulness, fairness and transparency; purpose limitation; storage limitation; integrity; confidentiality; security; accountability, and data minimization.
In practice, this means sponsors must clearly identify and document the lawful basis for using participant data, and they must explain to participants how their data will be used in the trial. For example, GDPR’s transparency requirement means consent forms and privacy notices must be “clear, open and honest with people about how you will use their personal data”.
Purpose limitation requires recording the trial’s objectives and using data only for those purposes, unless new consent is obtained. And the minimization principle mandates collecting only the personal data that are “adequate, relevant and limited to what is necessary” for the study.
Beyond Article 5, GDPR Article 25 enshrines data protection by design and by default. This obliges trial sponsors to integrate safeguards early on – for example, using pseudonymization and encryption to protect health data, and configuring databases so that only needed data fields are active. A practical approach might be to build systems that automatically limit access and require secure logins, in line with GDPR’s design requirements.
Data Protection Impact Assessments (DPIAs) are a critical GDPR tool for trials. Given the nature of the data involved (i.e., special category health data), the close monitoring of participants, and the applicable legal and ethical frameworks, a DPIA is mandatory in virtually all cases for clinical trials.
Incorporating GDPR’s transparency, purpose, minimization, and by-design principles (often through tools like DPIAs) ensures clinical research compliance with data-protection laws as well as health regulations.
Clinical trial compliance faces many practical hurdles. Some of them are as follows:
Many researchers, especially those new to clinical studies, conflate routine medical practice with regulated research. Without proper training in GCP, local regulations, and clinical research compliance investigators can inadvertently skip essential steps like obtaining informed consent or following the protocol exactly. It leads to data discrepancies and regulatory warnings.
Smaller sites or community clinics often lack dedicated compliance teams, relying instead on overburdened staff to juggle patient care and ensuring regulatory compliance. Without strong electronic systems or enough personnel, it’s easy for documentation to fall behind, audit trails to go incomplete, and critical deadlines to be missed.
Navigating GDPR, UK GDPR, and other data-protection laws adds a layer of complexity to trials. Sponsors must implement strong safeguards for personal health information, such as encryption, pseudonymization, and strict access controls, even when transferring data across borders. Failure to meet these standards can result in hefty fines and trial delays.
The rise of remote monitoring, mobile health apps, and telemedicine introduces new compliance puzzles. Ensuring secure, validated digital platforms and reliable electronic consent processes becomes crucial when sites and participants operate virtually, increasing the risk of inconsistent data handling.
Regulatory bodies continually update requirements, whether on pandemic-related flexibilities, new diversity mandates, or enhanced reporting standards. Staying current with these changes and adapting trial processes quickly can stretch resources thin and create gaps if not managed proactively.
Successful trials implement multiple layers of controls. Industry experts advise a multi-pronged approach that includes strong consent processes, centralized oversight, strict data controls, ongoing monitoring, and staff training. Below are key areas of focus:
Teams should use clear, comprehensive consent forms and privacy notices so participants truly understand the study, risks, and data usage. Regulations (FDA 21 CFR 50, EU CTR, etc.) require that subjects be “fully informed” about the trial. The GDPR’s transparency rules also demand that privacy information (data use, rights, etc.) be provided upfront.
Establishing a single data-governance framework is crucial. This means designating a data controller or governance committee responsible for policies on data collection, storage, retention, and disposal across all trial sites. A centralized governance plan clarifies roles and standardizes procedures. For example, who can see personal data, how long it’s kept, backup practices. GDPR data governance includes all the crucial factors required under clinical compliance as well. Thus, following an effective data governance framework is essential that can serve multiple purposes.
Clinical trials involve sensitive data flows across departments, sites, labs, and even countries. Strong sharing controls are a must. Internally, site teams should handle participant data only on secure networks (no private USB drives or personal email). All data exports (e.g., to a central database) should go through encrypted channels. Externally, any transfer of personal health data, for example, to a CRO or to labs, must comply with the law. Wherever possible, data should be de-identified before sharing. Data minimization also emphasizes that only the minimum necessary information should be transferred.
In rare cases where transferring identifiable data is unavoidable, legal reviews and privacy-by-design measures (e.g., encrypted databases, access controls) are essential.
Compliance cannot be “set and forget.” Continuous oversight is needed. Sponsors should conduct periodic audits and monitoring of trial activities, both remotely and on-site, to detect any compliance gaps. Electronic records must meet 21 CFR Part 11 standards, meaning all entries should be timestamped with an audit trail. Data quality checks (e.g., source data verification) help catch protocol deviations early. FDA’s BIMO program routinely inspects trials to protect subjects and data integrity.
A strong compliance program invests in people. All research staff, investigators, coordinators, and data managers need training in GCP, privacy rules, and study procedures. This includes understanding how FDA/ICH and GDPR apply to their daily tasks. The team should have a clear organizational chart or delegation log so everyone knows their compliance responsibilities. Even small CROs or sites can leverage external expertise.
Under GDPR and UK GDPR, organizations involved in clinical trials must appoint a Data Protection Officer (DPO) to oversee privacy compliance. In the clinical trial context, a sponsor or CRO likely needs a DPO if its core activities involve large-scale processing of special-category health data or systematic monitoring of participants. The DPO’s job is to "oversee data protection strategy and implementation in compliance with the GDPR". This means the DPO advises on GDPR obligations, monitors data flows, assists with DPIAs, provides training, and acts as the liaison with regulators.
The DPO also helps prepare documentation (records of processing, breach logs, etc.) to demonstrate clinical compliance along with required compliance. A qualified DPO must have expert knowledge of GDPR and medical privacy. Smaller organizations often engage an Outsourced DPO services firm so they meet the requirement without hiring full-time staff.
Contracting an expert DPO or GDPR consultant can greatly streamline compliance. For example, a DPO consultant can perform a full GDPR audit of your trial processes reviewing consent language, data inventory, and security policies to pinpoint gaps. They can develop and execute Data Protection Impact Assessments (DPIAs) tailored to the study protocol (for example, for a genomic trial or a multi-national project).
Partnering with DPO Consulting equips your organization with expert guidance to ensure total clinical trial compliance in every country where you host studies. We also helps organizations with complex cross-border issues under UK and EU GDPR, such as setting up appropriate data transfer mechanisms between sites in different regions.
In addition, our outsourced DPO services can establish an effective GDPR data governance framework for your organization.
The compliance in clinical trial involves meeting all legal and ethical requirements—GCP/ICH standards, IRB approval, informed consent, accurate reporting, and secure data handling—to protect participants and ensure credible results.
The regulatory requirement for clinical trial compliance depends on location: in the U.S., follow FDA rules (e.g., 21 CFR Parts 11, 50, 56, 312); in the EU, adhere to Clinical Trials Regulation 536/2014 and ICH-GCP; plus local laws like the MHRA in the UK or PMDA in Japan.
21 CFR Part 11 specifies the FDA’s rule for electronic records and signatures. It requires system validation, audit trails, secure user access, and controls to make digital trial data legally equivalent to paper.
FDA regulations are a suite of rules in Title 21 CFR covering informed consent (Part 50), IRBs (Part 56), investigational products (Parts 312/812), electronic systems (Part 11), and more guidance on GCP.
If they process large-scale or special-category personal data of EU/UK participants, yes. Many small CROs opt for outsourced DPO services to meet GDPR/UK GDPR requirements without hiring full-time staff.
The compliance takes place through audits and inspections (e.g., FDA BIMO), metrics like protocol deviations or training completion rates, and the successful resolution of any findings via corrective actions.
Non-compliance of GDPR while conducting clinical trials can cause fines that can reach €20 million or 4% of global turnover, plus orders to halt processing, regulatory remediation, and reputational damage.
Required for high-risk processing (e.g., extensive health data). DPIAs identify privacy risks, document them, and outline mitigation steps before the trial begins.
Clinical data can only be fully anonymized data (irreversibly de-identified) outside GDPR. In most trials, data remain pseudonymized and thus still protected, so GDPR rules apply.
Investing in GDPR compliance efforts can weigh heavily on large corporations as well as smaller to medium-sized enterprises (SMEs). Turning to an external resource or support can relieve the burden of an internal audit on businesses across the board and alleviate the strain on company finances, technological capabilities, and expertise.
External auditors and expert partners like DPO Consulting are well-positioned to help organizations effectively tackle the complex nature of GDPR audits. These trained professionals act as an extension of your team, helping to streamline audit processes, identify areas of improvement, implement necessary changes, and secure compliance with GDPR.
Entrusting the right partner provides the advantage of impartiality and adherence to industry standards and unlocks a wealth of resources such as industry-specific insights, resulting in unbiased assessments and compliance success. Working with DPO Consulting translates to valuable time saved and takes away the burden from in-house staff, while considerably reducing company costs.
GDPR and Compliance
Outsourced DPO & Representation
Training & Support
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