The TIMI Hotline is a communication system that includes telephone, pager and email. The purpose of the TIMI Hotline is to provide trial support to all participating active trial sites worldwide.
Examples of hotline support include advice regarding:
- Protocol inclusion & exclusion criteria
- Implementation of protocol procedures
- Completion of case report forms
- Handling of study drug in complex medical situations
- Protocol responses to and reporting of endpoint and serious adverse events
- Potential discontinuation of study drug and withdrawal of consent
- Requests to unblind study drug
Medical issues are handled directly by TIMI cardiologists, all of whom are medically qualified and have completed training in all aspects of the protocol. A TIMI cardiologist is available by pager/telephone 24 hours a day and 7 days a week for all urgent medical issues. Operational and other non-urgent questions are handled by dedicated members of the TIMI trial team by email or telephone during regular business hours.