Prevention of Post-Traumatic Contractures with Ketotifen II (PERK2)
Abstract
Regulatory approvals - US Food and Drug Administration, USAMRMC Human Research Protections Office (HRPO), Health Canada -- have been completed for 10 participating sites. Remaining 7 sites are poised for imminent approval. Nine of the participating sites have received ethics approval in addition to all Calgary lead sites. Site initiation visits were completed at 6 sites, with 3 actively recruiting and 3 with prospective start dates during Q1 of Year 3. Bay Area Research Logistics (BARL) has completed shipment of medication to all active and close to active sites. The Epidemiology Coordinating and Research Centre (EPICORE) at the University of Alberta organized screening, randomization and enrolment procedures, including the coordination of medication distribution between local sites and BARL using a custom program called Drug Tracking System (DTS). In addition, EPICORE is using the FDA compliant RedCap as the electronic data capturing system. These efforts have led to active sites successfully recruiting and randomizing 9 participants. Hiring and transition to a new coordinator supporting regulatory, budget, data and trial coordinating functions has been achieved. Site contract negotiations have been completed at 13 sites, with the remaining four to be done during Q1 of Year 3. Site training sessions were completed in June and September 2019. Charters for Data Monitoring Committee (DSMB), Trial Steering Committee (TSC), and Trial Management Group (TMG) were developed. Two abstracts for presentation and one manuscript drafts in development for publication. Regulatory approvals - US Food and Drug Administration, USAMRMC Human Research Protections Office (HRPO), Health Canada -- have been completed for 10 participating sites. Remaining 7 sites are poised for imminent approval. Nine of the participating sites have received ethics approval in addition to all Calgary lead sites. Site initiation visits were completed at 6 sites, with 3 actively recruiting and 3 with prospe
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2019
- Accession Number
- AD1097832
Entities
People
- Kevin A Hildebrand
Organizations
- University of Calgary