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Glossary (entities, fields)

Trial - clinical study (main entity)

Cochrane name: study

Drug - a chemical substance that has known biological effects on humans

Question: Does Cochrane database have it?

HealthCondition - illness, injury, impairment etc

RegisterEntry - a record in the trial registrar organization

Question: trial-registry is o2m or m2m?

ResultsDoc - a paper (or similiar) about the trial

Design - trial methodology

Cochrane options: RCT or CCT (see additional glossary)

Intervention - interposition or interference, drug, therapy etc

Cochrane example: Acceptance and Commitment Therapy + Treatment as Usual
Question: do we have to have separate entity for it as in the Cochrane database?

Method - some trial implementation rules

Cochrane example: Randomised - date of admission, odd or even

Participant - a man involved in a trial as a part of a research

Question: do we have to have separate entity for it as in the Cochrane database?

Outcome - trial result metrics

Cochrane example: Global improvement / deterioration

Glossary (additional)

CCT - A case-control study is a type of study design used widely, originally developed in epidemiology, although its use has also been advocated for the social sciences. It is a type of observational study in which two existing groups differing in outcome are identified and compared on the basis of some supposed causal attribute.

https://en.wikipedia.org/wiki/Case-control_study
Cochrane relation: study design

MedDRA - Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary

https://en.wikipedia.org/wiki/MedDRA

RCT - randomized controlled trial is a type of scientific (often medical) experiment, where the people being studied are randomly allocated one or other of the different treatments under study.