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| A [[Wikipedia's English Clinical Research Glossary]] is a [[English glossary|English]] [[clinical research glossary]] that is a [[Wikipedia-based glossary]].
| | #REDIRECT [[Wikipedia's English Clinical Research Glossary]] |
| * <B>Example(s):</B>
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| ** [[English Wikipedia's Glossary of Clinical Research]] [https://en.wikipedia.org/wiki/Glossary_of_clinical_research]
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| ** ...
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| * <B>Counter-Example(s):</B>
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| ** a [[French Clinical Research Glossary]], such as: <code>https://notre-recherche-clinique.fr/lexique/</code>
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| * <B>See:</B> [[Clinical Research Terminology]].
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| ----
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| ----
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| == References ==
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| === 2021 ===
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| * (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-6.
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| ** A [[glossary]] of terms used in [[clinical research]].
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| * '''[[Activities of daily living]]'''
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| * '''[[Adverse drug reaction]]'''
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| * '''[[Adverse effect]]'''
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| * '''[[Adverse effect|Side effect]]'''
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| * '''[[Adverse event]]'''
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| * '''[[Adverse reaction]]'''
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| * '''[[Animal model]]'''
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| * '''[[Animal study]]'''
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| * '''[[Approved drugs]]'''
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| * '''[[Arm]]'''
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| * '''[[Audit report]]'''
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| * '''[[Audit trail]]'''
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| * '''[[Audit]]'''
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| * '''[[Baseline (medicine)|Baseline]]'''
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| * '''[[Bayesian inference|Bayesian]]''' approaches
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| * '''[[Best practice]]'''
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| * '''[[Bias]]'''
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| * '''[[Bioavailable]]'''
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| * '''[[Bioinformatics]]'''
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| * '''[[Biological drug]]'''
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| * '''[[Biometrics]]'''
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| * '''[[Biometry]]'''
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| * '''[[Biostatistics]]'''
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| * '''[[Blinded study]]'''
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| * '''[[Case report form]]'''
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| * '''[[Case report]]'''
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| * '''[[Case series]]'''
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| * '''[[Case-control study]]'''
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| * '''[[Clinical endpoint|Endpoint]]'''
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| * '''[[Clinical endpoint|Outcome]]'''
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| * '''[[Clinical investigator]]'''
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| * '''[[Clinical investigator|Investigator]]'''
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| * '''[[Clinical practice guidelines]]'''
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| * '''[[Clinical researcher]]'''
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| * '''[[Clinical series]]'''
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| * '''[[Clinical study]]''' or '''Clinical trial'''
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| * '''[[Clinical trial protocol]]'''
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| * '''[[Cohort (statistics)]]'''
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| * '''[[Cohort study]]'''
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| * '''[[Community-based clinical trial]] (CBCT)'''
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| * '''[[Comparator]]'''
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| * '''[[Compassionate use trial]]'''
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| * '''[[Compassionate use]]'''
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| * '''[[Complementary and alternative therapy]]'''
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| * '''[[compliance (regulation)|Compliance]]'''
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| * '''[[Confidentiality]] regarding trial participants'''
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| * '''[[Consecutive case series]]'''
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| * '''[[Content validity]]'''
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| * '''[[Contract Research Organization]]'''
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| * '''[[Contract]]'''
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| * '''[[Contraindication]]'''
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| * '''[[Control group]]'''
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| * '''[[Controlled trials]]'''
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| * '''[[Controlled trials|Controlled clinical trial]]'''
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| * '''[[Data and Safety Monitoring Board]]''' or '''Independent Data Monitoring Committee'''
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| * '''[[Diagnosis|Diagnostic]] trials'''
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| * '''[[Documentation]]'''
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| * '''[[Dose (biochemistry)#Effects are dose-dependent|Dose-dependent]]'''
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| * '''[[Dose (biochemistry)|Dose]]'''
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| * '''[[Dose-ranging study]]'''
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| * '''[[Double-blind study]]'''
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| * '''[[Double-blind|Blind]]'''
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| * '''[[Dropping out|Dropout]]'''
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| * '''[[Drug interaction|Drug–drug interaction]]'''
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| * '''[[Drug]]'''
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| * '''[[Efficacy]]'''
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| * '''[[Empirical]]'''
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| * '''[[Epidemiology]]'''
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| * '''[[Expanded access trial]]'''
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| * '''[[Expanded access]]'''
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| * '''[[Experimental drug]]'''
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| * '''[[Experimental techniques|Experimental]]'''
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| * '''[[Food and Drug Administration]] (FDA)'''
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| * '''[[Frequency probability|Frequentist methods]]'''
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| * '''[[Good clinical practice]]'''
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| * '''[[Healthcare professional|Clinician]]'''
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| * '''[[Historic cohort study]]'''
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| * '''[[Human subject research|Human subject]]'''
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| * '''[[Hypothesis]]'''
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| * '''[[In vitro]]'''
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| * '''[[In vivo]]'''
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| * '''[[Incidence (epidemiology)|Incidence]]'''
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| * '''[[Indication (medicine)|Indication]]'''
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| * '''[[Informed consent]]'''
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| * '''[[Inspection]]'''
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| * '''[[Institution]]'''
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| * '''[[Institutional Review Board]] (IRB)'''
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| * '''[[Inter-rater reliability]]'''
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| * '''[[Interaction]]''' (Qualitative & Quantitative)
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| * '''[[Interest group|Advocacy]] and [[support group]]s'''
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| * '''[[Interim analysis]]'''
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| * '''[[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH]] E6''': {{citation | title = Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance | publisher = [[U.S. Department of Health and Human Services]], [[Food and Drug Administration]] | date = April 1996 | url = https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf}}
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| * '''[[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH]] E9''': {{citation | title = Guidance for Industry - E9 Statistical Principles for Clinical Trials | date = September 1998 | url = https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf| publisher = [[U.S. Department of Health and Human Services]], [[Food and Drug Administration]] }}
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| * '''[[Intra-rater reliability]]'''
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| * '''[[Investigational drug]]'''
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| * '''[[Investigational New Drug]]'''
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| * '''[[Investigator's Brochure]]'''
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| * '''[[Levels of evidence]]'''
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| * '''[[Masked]]'''
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| * '''[[Medication]]'''
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| * '''[[Medicine]]'''
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| * '''[[Meta-analysis]]'''
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| * '''[[Monitoring in clinical trials|Monitoring]]'''
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| * '''[[National Cancer Institute|NCI]]''': {{citation | url = http://www.cancer.gov/dictionary/db_alpha.aspx | publisher = [[National Cancer Institute]] | title = Dictionary of Cancer Terms}}
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| * '''[[National Institutes of Health]]'''
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| * '''[[Natural history study]]'''
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| * '''[[New Drug Application]] (NDA)'''
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| * '''[[Nonconsecutive case series]]'''
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| * '''[[Observation]]'''
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| * '''[[Observational study]]'''
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| * '''[[Off-label]]'''
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| * '''[[Open label study]]'''
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| * '''[[Orphan drugs]]'''
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| * '''[[Outpatient]]'''
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| * '''[[Over-the-counter drug]]'''
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| * '''[[Patient advocate]]'''
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| * '''[[Peer review]]'''
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| * '''[[Pharmacokinetics]]'''
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| * '''[[Phase I clinical trials]]'''
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| * '''[[Phase II clinical trials]]'''
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| * '''[[Phase III clinical trials]]'''
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| * '''[[Phase IV clinical trial]]'''
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| * '''[[Physical examination|Clinical]]'''
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| * '''[[Pilot study]]'''
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| * '''[[Placebo effect]]'''
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| * '''[[Placebo-controlled studies|Placebo controlled study]]'''
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| * '''[[Placebo]]'''
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| * '''[[Population study]]'''
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| * '''[[Preclinical]]'''
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| * '''[[Preventive medicine|Prevention]]'''
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| * '''[[Prospective cohort study]]'''
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| * '''[[Quality Assurance]]'''
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| * '''[[Quality of life]] trials (or supportive care trials)'''
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| * '''[[Randomization]]'''
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| * '''[[Randomized clinical trial]]'''
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| * '''[[Recruitment|Recruiting]]'''
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| * '''[[Regimen]]'''
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| * '''[[Retrospective cohort study]]'''
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| * '''[[Retrospective]]'''
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| * '''[[Risk-benefit ratio]]'''
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| * '''[[Scientific control|Control]]'''
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| * '''[[Selection bias]]'''
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| * '''[[Single blind study]]'''
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| * '''[[sponsor (commercial)|Sponsor]]'''
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| * '''[[Standard Operating Procedures]]'''
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| * '''[[Standard treatment]]'''
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| * '''[[Standards of care]]'''
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| * '''[[Statistical significance]]'''
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| * '''[[Statistical significance|Significant]]'''
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| * '''[[Study endpoint]]'''
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| * '''[[t-test]]'''
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| * '''[[Title 21 of the Code of Federal Regulations|21CFR312.3]]''': {{citation | title = Code of Federal Regulations, Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Part 312--Investigational New Drug Application, Subpart A--General Provisions, Sec. 312.3 Definitions and Interpretations | url = http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html}}
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| * '''[[Title 21 of the Code of Federal Regulations|21CFR50.3]]''': {{citation | title = Code of Federal Regulations, Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Part 50--Protection of Human Subjects, Subpart A--General Provisions, Sec. 50.3 Definitions | url = http://edocket.access.gpo.gov/cfr_2002/aprqtr/21cfr50.3.htm}}
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| * '''[[Toxicity]]'''
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| * '''[[Treatment IND]]'''
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| * '''[[United States National Library of Medicine|NLM]]''': {{citation | url = http://clinicaltrials.gov/ct2/info/glossary | publisher = [[U.S. National Library of Medicine]] | title = Glossary of Clinical Trials Terms | access-date = 2008-10-05 | archive-url = https://www.webcitation.org/61BHrqVfM?url=http://clinicaltrials.gov/ct2/info/glossary | archive-date = 2011-08-24 | url-status = dead }}
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| * '''Applicable regulatory requirement'''
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| * '''Approval''' (in relation to institutional review boards (IRBs))
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| * '''Audit certificate'''
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| * '''Blind review'''
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| * '''Clinical investigation'''
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| * '''Clinical Trial/Study Report'''
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| * '''Control animal'''
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| * '''Coordinating Committee'''
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| * '''Coordinating Investigator'''
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| * '''Direct Access'''
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| * '''Dose-limiting'''
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| * '''Dose-rate'''
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| * '''Double-dummy'''
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| * '''Eligibility criteria'''
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| * '''Enrolling'''
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| * '''Equivalence trial'''
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| * '''Essential Documents'''
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| * '''Evaluable disease'''
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| * '''Evaluable patients'''
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| * '''Follow-up'''
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| * '''Full analysis set'''
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| * '''Generalisability, Generalisation'''
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| * '''Global assessment variable'''
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| * '''Healthy control'''
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| * '''Historical control subject'''
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| * '''Impartial Witness'''
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| * '''Inclusion/exclusion criteria'''
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| * '''Independent Ethics Committee'''
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| * '''Informed consent document'''
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| * '''Intent to treat'''
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| * '''Interim Clinical Trial/Study Report'''
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| * '''Intervention group'''
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| * '''Intervention name'''
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| * '''Intervention'''
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| * '''Investigational'''
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| * '''Legally Acceptable Representative'''
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| * '''Maximum tolerated dose'''
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| * '''Monitoring Report'''
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| * '''Multicenter study'''
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| * '''Multidisciplinary opinion'''
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| * '''Multiplicity'''
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| * '''Non-inferiority trial'''
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| * '''Nonblinded'''
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| * '''Nonclinical Study'''
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| * '''Nonrandomized clinical trial'''
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| * '''Objective improvement'''
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| * '''Objective response'''
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| * '''Per protocol set''' (Valid Cases, Efficacy Sample, Evaluable Subjects Sample)
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| * '''Phase I/II trial'''
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| * '''Phase II/III trial'''
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| * '''Placebo therapy'''
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| * '''Predictive factor'''
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| * '''Prevention trials'''
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| * '''Preventive'''
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| * '''Primary endpoint'''
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| * '''Prospective'''
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| * '''Protocol Amendment'''
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| * '''Quality Control'''
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| * '''Recruitment status'''
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| * '''Regulatory Authorities'''
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| * '''Retrospective study'''
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| * '''Safety & tolerability'''
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| * '''Screening trials'''
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| * '''Serious Adverse Event'''
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| * '''Sham therapy'''
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| * '''Source Data'''
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| * '''Source Documents'''
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| * '''Sponsor-Investigator'''
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| * '''Statistical analysis plan'''
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| * '''Study type'''
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| * '''Subinvestigator'''
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| * '''Subject Identification Code'''
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| * '''Subject/Trial Subject'''
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| * '''Superiority trial'''
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| * '''Surrogate variable'''
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| * '''Test article'''
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| * '''Treatment effect'''
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| * '''Treatment emergent'''
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| * '''Treatment trials'''
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| * '''Trial Site'''
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| * '''Trial statistician'''
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| * '''Uncontrolled study'''
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| * '''Unexpected Adverse Drug Reaction'''
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| * '''Vulnerable Subjects'''
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| * '''Well-being of the trial subjects'''
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| ----
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| [[Category:Concept]]
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| __NOTOC__
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