4 Tips for Conducting a Clinical Investigation from a CRA Perspective

Written by Iris Verboven | Sep 23, 2025 5:30:00 AM

Conducting a clinical investigation can feel overwhelming, especially if you’re new to the medical device industry. Clinical Research Associates (CRAs) play a vital role in guiding these investigations, ensuring they are conducted efficiently, ethically, and in full compliance with regulations. Whether you are exploring clinical investigations for the first time, facing challenges during ongoing studies, or considering professional support, these four CRA-informed tips will help you navigate the process successfully.

A Clinical Research Associate (CRA) plays a key role in ensuring that a clinical investigation is conducted effectively, ethically, and in compliance with regulatory requirements. While investigators and sponsors are responsible for the execution of the study, the CRA acts as the critical link between sites, sponsors, and regulatory expectations. With oversight, monitoring, and attention to detail, the CRA helps safeguard both the integrity of the study and the safety of patients.

Here are 4 important tips for managing a clinical investigation from the CRA perspective:

If it isn’t documented, it didn’t happen
Accurate and complete documentation is essential. From start-up through close-out, every activity must be recorded in the Trial Master File and the Investigator Site File. Missing or poorly organized documentation can lead to significant findings during audits, or even to data being rejected for submission. To avoid this, ensure that filing systems are structured, logical, and aligned with ISO 14155 requirements.
Be audit-ready at all times
Unannounced audits by Notified Bodies are a reality. Auditors will review Trial Master Files, Investigator Site Files, and electronic filing systems in detail. The CRA’s responsibility is to verify that all required documents are present, accurate, and accessible, so that the study can be fully understood from beginning to end. A well-prepared file is not only a regulatory requirement, it is also the foundation for a successful submission.
Protect privacy and comply with GDPR
Clinical investigations generate a large volume of patient and staff data. GDPR regulations impose strict requirements on how this data is handled, stored, and shared. The CRA ensures that sensitive information is managed properly, and that privacy is protected at every stage. Non-compliance can result in heavy penalties and reputational damage, making vigilance essential.
Think long-term
Archiving does not end when the study closes. Documentation must remain accessible for years after the investigation concludes—sometimes up to 15 years—since safety signals may emerge long after initial data collection. Ensuring long-term, secure archiving is a vital step in protecting patients and maintaining regulatory compliance.

Why it matters

The CRA’s role goes beyond monitoring visits. By overseeing documentation, verifying compliance, and maintaining patient safety standards, CRAs help sponsors avoid costly errors, delays, or findings that could jeopardize their market approval. When the correct procedures and systems are followed, sponsors can have confidence that their trial is audit-ready and compliant at all times.

Clinical investigations are complex, but with the right oversight and attention to detail, they can be conducted smoothly and successfully.

Clinical investigations can be complex, but you don’t have to navigate them alone. Contact Celien today for a free 30-minute consultation to receive personalized guidance and insights from a CRA perspective. Ensure your study runs efficiently, stays compliant, and produces high-quality, credible results.

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