Table 1. Phase I registries of healthy subjects in various countries.

Database	Who enrolls	Exclusion/washout period	Data collection	Strengths/benefits	Weaknesses/risks	Multisite viewing of information?	Cost	Regulator
Southern Switzerland Regional Registry	Healthy volunteers Site participation mandatory	PI dependent, at least 3 months	Volunteer code (initials + DOB + gender + nationality), CRU, study name, and date that subject is allowed to participate again in another trial Data purge after 5 years	Subjects caught are excluded from all future studies. Only those involved with study can access information; no other sites can do so. Subject identity protected on computer with no network access and alarm system.	Subject cannot refuse to be on registry.	No	Government financed by exam/approval fees (∼500 Swiss Francs per study)	Swiss National Science Foundation
United Kingdom/TOPS	Healthy volunteers for phase I trials Site participation voluntary	Systemic drugs: 3 months minimum Cannot receive >10 mSv of radioactivity in any 12-mo period	Unique ID (national insurance number or UK citizens or passport number) at screening and the date of last dose of study drug Data purge after 2 years	De-identified data Site has flexibility with trials that have long follow-up (>4 weeks) Simple, Web-based interface	Usernames and password protected by authorized users Input errors require calls to other sites to clarify participation history.	Web-based and all authorized CRUs can share/view whether a subject has registered but cannot view the last dose day (must contact the CRU).	Registered nonprofit organization Free to sites	The individual site and TOPS administration
France	Subjects in whom research has no direct benefit Site participation mandatory	PI dependent	Code derived from subjects' names/DOB; start/end dates of study; end date of exclusion period; financial compensation	Data purge 1 year after the last date is entered	Based on annual salary ($4,000 annually) No protection against ID theft, privacy Subject must show proof of national health insurance	All authorized research centers have direct access.	Government public finance	Ministry of Health
United States and Canada/clinicalRSVP	Any subject who receives compensation for trial Site participation voluntary	PI/study dependent	Biometric data (fingerprint code), last dose date Data purge after 5 years	Subjects can dispute information entered into database if not accurate Transparent tracking and auditing Limited collection of subject data	Voluntary basis allows subjects to seek nonparticipating sites when dual enrolling. Effectiveness is reduced unless many sites in a region participate.	Sites can view only last date of study drug administration.	Private sector training + install = ∼$ 1,500 $40 per subject per study	Private corporation
United States and Canada/Verified Clinical Trials	Any subject who receives compensation for trial Site participation voluntary	PI/study dependent	Web-based portal	Validity of subject identification checked against publicly available databases.	Voluntary basis allows subjects to seek nonparticipating sites when dual-enrolling. Effectiveness is reduced unless many sites in a region participate.	Sites can view whether a subject is eligible.	$500 per study	Private corporation

clinicalRSVP, Clinical Research Subject Verification Program; CRU, clinical research unit; DOB, date of birth; mSv, millisievert; PI, principal investigator; TOPS, The Over Volunteering Prevention System.