Rationale

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.

Impact

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:

Benefits

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

Available Assets

For additional information on SQT’s resources, please click the Initiative Assets button below.

Similar Initiatives

Quality Management System

LEARN MORE >

Risk Based Monitoring

LEARN MORE >

Shared Investigator Platform

LEARN MORE >