Clinical Operations & Regulatory Affairs
Clinical operations, regulatory affairs and quality leads carry most of the day-to-day data protection load in a sponsor: the ICF wording a German ethics committee has queried; the data protection section of a protocol for CTIS submission; the clinical trial agreement a French site insists must follow the national template; the CRO's data processing agreement; the vendor questionnaire from an imaging provider; the investigator who asks who the EU representative is.
Each question has a precise regulatory answer — Art. 13 GDPR for the ICF, Art. 28 for the CRO contract, Art. 27 for the representative, the Clinical Trials Regulation 536/2014 for the protocol — and each answer has to arrive before the study milestone, not after.
iliomad works inside your study timelines. Our consultants review documents in tracked changes with the regulatory rationale, join site and CRO calls when needed, and maintain the study compliance file so that your inspection readiness does not depend on a folder someone left behind.
Where data protection meets the study timeline
The items below are the recurring data protection deliverables of a clinical study. Each is tied to a milestone — ethics submission, site activation, database lock, archiving — and each is reviewed by someone outside the company.
Ethics committees review the data protection language of the ICF against Art. 13 GDPR and national requirements: the controller and representative, legal bases, transfers outside the EU, retention, rights and contact points. Germany, France, Italy and Spain each have their own expectations. iliomad reviews master and country ICFs with tracked changes and rationale — see ICF review.
The protocol's confidentiality and data protection section must be consistent with the ICF, the DPIA and the CTA, and must describe pseudonymisation, data flows, retention and secondary use in a way a competent authority accepts. Special topics — eDiaries, photography, future biomedical research, genetic data — need model language. iliomad reviews protocols before submission.
Several countries impose mandatory CTA templates whose data protection clauses cannot be freely amended; others require GDPR Art. 28 or joint-controller language to be added. Site legal departments push back on sponsor paper. iliomad reviews CTAs against the country template and the GDPR checklist and gives the site a reasoned position — see contractual review.
Each CRO, laboratory, EDC, IRT, imaging and eCOA vendor is a processor requiring a DPA, a transfer mechanism and a security assessment before data flows. Study start dates slip when this is done late. iliomad runs the assessment and the contract review in parallel with vendor selection — see vendor assessment.
The DPIA required by Art. 35 GDPR is also the document that answers most site and ethics-committee questions. It maps every actor and every flow, scores the risks and records the measures. iliomad produces it from the protocol, ICF, agreements and data management plan, and updates it when the study changes — see DPIA.
Investigators and site staff are data subjects too: their professional data is processed for trial conduct and pharmacovigilance, and they need a notice under Art. 13 and 14 GDPR. Inspectors ask for it. iliomad drafts site staff information notices, maintains the record of processing per study and supports inspection responses.
How iliomad Health Data can help you
iliomad Health Data's consultants are certified data protection professionals with clinical research experience; they read protocols, understand CTIS and speak to CROs and sites in their own terms. Reviews are delivered as tracked-changes Word documents with the regulatory rationale in comments, on agreed turnaround times. The DPO mandate includes a monthly meeting with the clinical and regulatory team, so that questions are answered before they become findings.
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