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general/clinical-research

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Principal investigator

Leader of research project

general/clinical-research
Clinical research

Medical research using human test subjects

general/clinical-research
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Initiative to promote public health

general/clinical-research
Assay sensitivity
general/clinical-research
Common Technical Document

Internationally agreed format for drug approvals

general/clinical-research
Placebo

Substance or treatment of no therapeutic value

general/clinical-research
Phases of clinical research

Clinical trial stages using human subjects

general/clinical-research
Remote data entry
general/clinical-research
Multicenter trial
general/clinical-research
Clinical investigator

Investigator involved in clinical trials

general/clinical-research
Run-in period
general/clinical-research
Placebo-controlled study

Type of medical experiment

general/clinical-research
Clinical research associate

Medical research professional

general/clinical-research
Approved drug

Pharmaceutical product that successfully completed drug approval process

general/clinical-research
Clinical research coordinator
general/clinical-research
Clinical trial management system

Software system

general/clinical-research
Adverse event

Any event, symptom, or disease occurring during a medical treatment

general/clinical-research
Case report form

Document in clinical trial research

general/clinical-research
Clinical data management system

Data management system used in clinical research

general/clinical-research
Clinical trial portal
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Good clinical data management practice

Industry standards for managing clinical trial data

general/clinical-research
Crossover study

Research study in medicine

general/clinical-research
Electronic data capture

Clinical data collection system

general/clinical-research
Clinical trials unit

Specialised biomedical research unit

general/clinical-research
Haybittle–Peto boundary
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Clinical trials publication

Publishing clinical trial research in peer-reviewed journal

general/clinical-research
Inclusion and exclusion criteria

Traits which permit participation in a clinical trial

general/clinical-research
Monitoring in clinical trials
general/clinical-research
Jadad scale

Procedure to assess the quality of clinical trials

general/clinical-research
Minimisation (clinical trials)
general/clinical-research
Outline of clinical research

Medical research using human test subjects

general/clinical-research
Patient diary

Method of monitoring a medical condition or treatment

general/clinical-research
Pharmacovigilance

Drug safety; subdiscipline of pharmacy relating to prevention of adverse effects of drugs

general/clinical-research
Patient-reported outcome

Outcome type in clinical trials

general/clinical-research
Linguistic validation
general/clinical-research
Validation (drug manufacture)

Documentary evidence of compliance

general/clinical-research
Source document
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Serious adverse event

Negative medical occurrence during a human drug trial

general/clinical-research
Investigational New Drug

USFDA program and procedures

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Postmarketing surveillance

Medical monitoring

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Data monitoring committee
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Case series

Type of medical research study

general/clinical-research
Investigator's brochure

Compilation of data regarding a drug undergoing human trials

general/clinical-research
Standard treatment
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Dynamic treatment regime
general/clinical-research