Traditionally, clinical trial investigators and sites are required to complete – for each company, and often, per trial – questionnaires, forms and training courses to prepare for participation in trials. The goal of this initiative is to enhance and simplify the clinical trial Site Qualification and Training (SQT) process by creating common tools and resources that reduce time spent on non-study specific tasks and therefore allow for more focus on protocol-related work.
The SQT Initiative collaborates 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.
- Minimum criteria for mutual recognition of GCP training
- Self-attestation process for external GCP training providers
- Common forms to collect generic site information
- Informational Programs for investigator site personnel
The benefits of the Site Qualification and Training Initiative are the realization of improved study start-up times through simplified and consistent approaches which will result in enhancement of efficiencies for sites.
With this, the collaboration with clinical trial sites will improve. Sites are expected to spend less time filling out duplicate forms and completing GCP training, as information will be collected in a consistent way. Investigators and site personnel may be able to use their already achieved GCP training certificate (from Member Companies or external training providers meeting the established minimum criteria) across TransCelerate Member Companies.
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 an 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.