Skip to content

Resources for Disruptions to Trials

The following are TransCelerate resources that can be referenced by sites and sponsors to support the continuity of clinical trials during disruption:

  • Tools to support centralized trial monitoring: TransCelerate’s Risk-Based Monitoring methodology and tools can be leveraged to transition from conventional, onsite monitoring. The model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. The methodology and tools can be adopted by any size organization and adapted to any type or phase of a clinical trial.
  • Tools to support the development of clinical study reports (CSR): TransCelerate’s CSR Considerations for Studies Disrupted by the COVID-19 Pandemic was created by clinical scientists, pharmacovigilance experts, data scientists, and other experts to identify the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19. In 2022, ACRO and TransCelerate have taken the lessons learned from the past three years and published proposals to address these challenges inPoints to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.
  • Tools to support protocol deviation management: With the COVID-19 pandemic drastically affecting clinical trial operations, protocol modifications may be required and there may be unavoidable protocol deviations. To help stakeholders navigate multiple aspects of protocol deviation management, TransCelerate has released a Protocol Deviations Toolkit earlier than anticipated. The toolkit offers clarification of the definition and provides a holistic approach to protocol deviations management, including a process guide, process map, decision tree, and an assessment tool. These tools were developed with feedback from Sites, CROs, and Health Authorities.
  • Tools to support issue and risk management: A Quality Management System aims to address quality and monitor and improve performance in complex clinical development-specific environments. TransCelerate’s Risk and Issue Management Tools provide a framework to provide end-to-end management of risks and issues and support an effective Corrective and Preventive Actions (CAPA) process.
  • Tools to support the use of patient-friendly technology: TransCelerate’s Patient Considerations Guide provides insights on patient perspectives and key considerations for using technology in clinical trials. As global health authorities have surfaced that trial participants may not be able to visit the investigational site for protocol-specified visits, sponsors may evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit) could be used. The guide provides considerations to aid a sponsor’s decision to use technology with patients to help in the current environment.