Lead Clinical Center
The lead Clinical Center is the C.S. Mott Children’s Hospital at the University of Michigan. Doctors at this site organized the team of expert co-investigators and consultants from across the US and Canada, who will participate collaboratively to conduct the THAPCA Trials. During the first year of the THAPCA Trials, there were 18 clinical centers enrolling infants and children who were eligible for the study. Since the first year of THAPCA, 16 more sites will be added to the study, for a total of 34 locations. To date we have enrolled over 100 infants and children.
The lead Clinical Center working closely with the Data Coordinating Center (DCC) is responsible for:
- Obtaining funding for the clinical site activities related to THAPCA
- Recruitment and selection of all clinical sites, study co-investigators, and consultants
- Writing or reviewing the study protocol and manual of operations
- Initial Institutional Review Board approval with consent forms and related materials for the THAPCA Trials
- Leading training sessions and committee meetings related to THAPCA
- Interactions with the funding agency personnel (NHLBI) and Data Safety monitoring Board (DSMB)
- Interactions with clinical sites and DCC related to relevant aspects of study
- Manuscript preparation with DCC
The lead scientific site includes a principal investigator, co-investigators, consultants, clinical nurse experts, and administrative support staff.
