12 September 2026 · 5 min read · By Clinical Trials
What Is a Clinical Trial Volunteer Passport — and Why India Needs One
How a verified volunteer passport helps healthy participants move between BA/BE studies safely, with dosing history, washout tracking and consent records in one place.
Every year, thousands of healthy volunteers in India take part in bioavailability and bioequivalence (BA/BE) studies. These studies are essential for bringing affordable generic medicines to market — but the system that tracks who has participated, and when, has historically been fragmented across individual CROs.
A clinical trial volunteer passport is a single, verified record of a participant's study history: screening results, dosing dates, washout periods and consent documents. Instead of each CRO keeping its own isolated file, the passport travels with the volunteer.
The 90-day washout problem
Regulators require a washout period — typically around 90 days — between a volunteer's last dosing and their enrolment in a new study. Without a shared record, a volunteer could dose at one CRO and screen at another within days, putting their safety and the study's data integrity at risk.
The Clinical Study Passport calculates the washout window automatically from verified dosing records and shows a live eligibility countdown, so both the volunteer and the CRO know exactly when the next study is safe.
What the passport does not do
A passport is not a medical decision. It shows verified history and consent records; the final eligibility decision always stays with the study doctor and the ethics committee. Volunteers keep control of their data and can request removal at any time.