Glossary
Clinical trials, in plain English.
The words I use every day, explained the way I'd explain them to a patient. If you're new to clinical research, start here.
- Clinical trial
- A carefully planned study that tests whether a new treatment is safe and works, in volunteers who agree to take part.
- Protocol
- The trial's rulebook: who can join, what happens at each visit, and what gets measured.
- EDCElectronic Data Capture
- The system where research sites record everything measured about participants during a trial.
- eCRFElectronic Case Report Form
- A digital form inside the EDC for one kind of information, like vital signs or a lab result.
- ePROElectronic Patient-Reported Outcomes
- Questionnaires patients fill in themselves, often on their phone, about symptoms and quality of life.
- Sponsor
- The company or organization that pays for and is responsible for a trial, often a pharma, biotech or device company.
- CROContract Research Organization
- A company a sponsor hires to run parts of the trial on its behalf.
- Site
- The hospital or clinic where participants are seen and data is collected.
- Query
- A question raised about a data point that looks wrong or incomplete, sent back to the site to confirm or fix.
- SDVSource Data Verification
- Checking that what's in the EDC matches the original records, like a patient's chart.
- Adverse event
- Any unwanted medical occurrence during a trial, whether or not it's caused by the treatment. Every one gets recorded.
- Database lock
- The moment trial data is frozen so no more changes can be made, and analysis can begin.
- 21 CFR Part 11
- The US FDA rule for when electronic records and signatures can be trusted like paper ones: audit trails, access control, e-signatures.
- GCPGood Clinical Practice
- The international standard (ICH E6) for running trials ethically, with reliable data and protected participants.
- CDISC
- Shared data standards (like CDASH and SDTM) so trial data can be exchanged and reviewed consistently by regulators.
- Real-world evidence
- Insights drawn from data collected outside trials, like health records and claims, about how treatments perform in everyday care.