Site Qualification and Training

The SQT Initiative collaborates with TransCelerate Member Companies, investigator sites, CROs and health authorities to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.

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
  • 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 the ability to mutually recognize GCP training
  • Reduced collection of duplicate information with model forms and templates
  • Increased collaboration with sites

Available Solutions

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

Related Initiatives

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

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.

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.