Traditionally, clinical trial investigators and sites are required to complete – for each company, and often, per trial – duplicative questionnaires, forms and training courses to prepare for participation in trials.
The Site Qualification and Training (SQT) Initiative collaborated with TransCelerate Member Companies, investigator sites, CROs and regulatory agencies to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.
The SQT Initiative has created the following model tools and resources that reduce time spent on non-study specific tasks, and therefore allow for more focus on protocol-related work:
- GCP Training Mutual Recognition Program
- 7 Forms
- 12 Informational Programs
- EDC System Training Mutual Recognition Program
- Integration with the Shared Investigator Platform
Benefits for Sites
- Reduced time spent completing GCP training
- Reduced time spent completing redundant training for different sponsors utilizing the same EDC system
- Ease of filling out forms and templates given consistent terminology and approach
- Resources available to support enhanced understanding of the conduct of clinical trials through Informational Programs
- More satisfying clinical trial start-up experience
Benefits for Sponsors
- Enhanced study start-up timelines due to ability to mutually recognize GCP training and quickly grant access to EDC systems
- Reduced collection of duplicate information with model forms and templates
- Increased collaboration with sites
For additional information on SQT’s resources, please click the Initiative Assets button below.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring Initiative seeks to develop a model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.
Shared Investigator Platform
The Shared Investigator Platform (SIP) will facilitate interaction between investigators and multiple clinical trial sponsors, enabling study planning, study start-up and study conduct activities while reducing the administrative burden on site staff.