Data Monitoring Committee
Our departments are collaborating to facilitate the establishment of DMCs (Data Monitoring Committees), DMC memberships, production and delivery of DMC safety data packages, and DMC meeting logistics. The Larix DMC collaboration offers the following services:
- Establishing a DMC, i.e. finding a suitable DMC chair and setting up a DMC charter
- Negotiating membership contracts with selected candidates
- Overseeing and documenting that there will be no conflicts of interest
- Specifying contents of DMC safety data packages in a DMC statistical analysis plan (SAP)
- Gathering all data input and producing validated DMC data packages
- Distributing DMC data packages prior to DMC meetings
- DMC meeting logistics (meeting invitations, travel arrangements, agenda, minutes)
- Training courses
- Providing a secured website for exchange of information
- Performing interim analyses, e.g. futility analyses and early efficacy analyses
- Setting up adjudication committees to evaluate certain types of SAEs
