Glossary
To go-in-depth with FACILITATE
Enter the world of our patient-centered project! Use this glossary of commonly used terms, their meanings and some insights to better understand responsible return of clinical trial data to patients and its reuse.
- Accountability
- Aggregate data
- Analytically unvalidated data
- Analyzable clinical dataset
- Anonymisation
- Anonymised data
- Article 15 GDPR
- Artificial Intelligence (AI) Act
- Autonomy
- Case Report Form (CRF)
- CISCRP
- Clinical endpoint
- Clinically actionable data
- Clinical outcome
- Clinical Outcomes Assessment (COA)
- Clinical study report (CSR)
- Clinical trial
- Clinical trial data
- Clinical trial phase
- Consent form
- Data reuse
- Direct Data Capture (DDC)
- e-Consent
- EFPIA
- Endpoint
- European Health Data Space (EHDS)
- General Data Protection Regulation (GDPR)
- Health literacy
- Individual patient data (IPD)
- Informed consent
- Innovative Health Initiative (IHI)-Innovative Medicines Initiative (IMI)
- Investigator
- Lay summary
- Metadata
- Multi-Regional Clinical Trials (MRCT) Center
- Observer reported outcome (ObsRO)
- Participant
- Patient
- Patient-centered
- Patient empowerment
- Patient engagement
- Patient experience
- Patient experience data
- Patient-focused drug development
- Patient partner (or advisor)
- Patient perspective
- Patient-reported outcome (PRO)
- Personal data
- Personally valuable result
- Person-centered care
- Plain language
- Primary endpoint
- Pseudonymisation
- Pseudonymised data
- Qualitative information
- Quantitative information
- Raw data
- Science of patient input
- Shared decision-making
- Sponsor
- Stakeholder
- Study protocol
- Summary of results
- Surrogate endpoint
- Urgent result
