Navigating consent, regulatory requirements, and data challenges in a multi‑country vascular graft study

A medical device company partnered with ICON to conduct a retrospective data collection study across several European countries. Instead of enrolling new patients, the study gathered existing clinical information on individuals previously treated with vascular grafts for peripheral artery disease, aortic aneurysms, or dialysis access. Sites contributed up to five years of historical data for two cohorts and up to two years for a third cohort, measured from each site’s initiation visit. Study start‑up began in June 2021 and relied on feasibility-driven site selection rather than traditional recruitment.

Operating across multiple European countries introduced significant variation in how ethics committees and regulatory bodies approached retrospective data use, especially around patient consent. Some countries required tailored consent forms or subject notification letters, while others allowed waivers. Requirements also differed for deceased or non‑reachable individuals, adding additional layers of complexity.

Regulatory changes in Italy, including the national restructuring of ethics committees, created an approval delay of approximately 15 months. Although many sites already had access to the required data, several struggled to enter it promptly into the electronic data capture system, placing pressure on timelines.

Key points

• Significant variation in ethics and regulatory requirements across countries
• Different rules for patient consent versus notification letters, including for deceased or non‑reachable subjects
• National restructuring of ethics committees in Italy that delayed approvals by about 15 months
• Slow data entry at sites despite data being readily available, increasing timeline risk

ICON proactively addressed regulatory and operational differences to keep the study moving forward. Local start‑up specialists mapped each country’s submission pathways early and prepared all required materials to secure approvals as efficiently as possible. To broaden data inclusion, ICON developed country‑specific notification letters and, where allowed, used consent waivers enabling the study to include deceased or non‑reachable patients and reducing selection bias.

To offset Italy’s extended approval timelines, ICON negotiated a nine‑month extension with the sponsor. Throughout the study, monthly site touchpoints kept teams focused and informed. To support sites with delayed data entry, ICON recommended and implemented Technical Site Visits, which helped resolve electronic data capture backlogs quickly.

What ICON delivered:

Regulatory preparation: Mapped and fulfilled each country’s ethics and regulatory submission requirements

Broader data inclusion: Used country‑appropriate notification letters and consent waivers to include deceased and non‑reachable subjects

Timeline protection: Secured a nine‑month extension to accommodate Italy’s regulatory delays

Consistent site engagement: Maintained regular communication through monthly outreach

Data acceleration: Conducted Technical Site Visits to help sites complete electronic data capture

By combining early regulatory planning, flexible data‑rights strategies, and hands‑on operational support, ICON delivered the study on time against the revised plan. Enrolment closed as targeted, all available data were entered, and data cleaning proceeded without additional delays. The database locked on schedule, and the sponsor expressed strong satisfaction, ultimately choosing ICON for additional retrospective studies.