TOPS (The Over-volunteering Protection System) is a web-based system that is currently used by a variety of CRO’s, Academic institutions and Pharmaceutical companies to monitor the participants of trials in the UK. The system currently has more than 95,000 registered volunteers.
To add volunteers to TOPS the consent of the volunteer must be received as well as the following details:
- National Insurance number (for UK citizens) or Passport Number and country of origin (if not a UK citizen).
- The date of the last dose of study medicine.
This data can only be accessed by the investigating unit in question and by other medical research organisations. All volunteer details are kept for a minimum of two years.
Upon accessing TOPS, users will be able to search for volunteers using their ID number (ie. National Insurance number or Passport number).
Subjects will be registered at the point of screening for a trial and the “last dose date” will be updated if and when the volunteer is dosed on a particular study. If the subject is not dosed then there is an option in TOPS to show that the subject was “never dosed”.
Contact details for units at which the volunteer has previously attended trials will be available as well as their last dose date.