Glossary
Understanding the key terms that will feature in project outputs (updated April 2021)
The aim of the glossary is to establish a common language and to aid understanding of key terms that will feature in project outputs. The glossary itself, presented in the document, may be updated during the Trials@Home project so that important new terms can be added, obsolete terms removed, or existing terms updated to significant new insights. This approach has been chosen to reflect the fast-changing remote decentralised clinical trial landscape.
For the creation and conception of the glossary, a workgroup was formed comprising members of work packages 1-5, 2 members per work package: one from the EFPIA side, and one from the public side. This workgroup then set out to find suitable concepts related to decentralised clinical trials (DCTs) for inclusion in the glossary.
- Adaptive trial design
- Auxiliary medicinal product
- Basic building block
- Big data
- Central monitoring
- Clinical study
- Clinical trial
- Controller
- Data consent
- DCTs
- Decentralised Clinical Trial
- Decentralised clinical trials
- Digital biomarker
- Digital trial
- Direct-to-participant
- Electronic case report form
- Electronic clinical outcome assessment
- Electronic consent
- Electronic health
- Electronic participant reported outcome
- Electronic patient reported outcome
- External stakeholder platform
- Health technology assessment
- Home trial support
- Hybrid trial
- Informed consent
- Investigational medicinal product
- Mobile health
- Non-investigational medicinal product
- Participant
- Patient
- Patient-centric trial design
- Personal data
- Personalised medicine
- Person identifiable data
- Processor
- Pseudonymisation
- RADIAL
- Randomisation and trial supply management
- Real world data
- Real world evidence
- Remote site monitoring
- Remote source data verification
- Scientific advisory board
- Study consent
- Subject
- Telemedicine
- Trial building block
- Trial site
- Wearables