Currently, the complexity and length of current Statistical Analysis Plans (SAPs) leads to delay in review and difficulty using the resulting data. Development of a Common SAP Template would limit rework and reduce complexity.
In 2019, this initiative will develop a Common SAP Template, which aims to provide a common layout and model content for SAP documentation, and will link directly to TransCelerate’s Common Protocol Template (CPT).
- Alignment with the CPT and content reuse could further increase the speed at which SAPs are completed, and potentially reduce data entry errors.
- Regulators would have greater ease of review because content would be more likely to be in a familiar location.
Please check back for more information.
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.