Wikipedia's Clinical Research Glossary: Difference between revisions

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#REDIRECT [[Wikipedia's English Clinical Research Glossary]]
A [[Wikipedia's Clinical Research Glossary]] is a [[Glossary]] that ...
* <B>AKA:</B> [[Glossary of Clinical Research]].
* <B>See:</B> [[Clinical Research]], [[Glossary]].
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== References ==
 
=== 2021 ===
* (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-6.
** A [[glossary]] of terms used in [[clinical research]].
 
* '''[[Activities of daily living]]'''
* '''[[Adverse drug reaction]]'''
* '''[[Adverse effect]]'''
* '''[[Adverse effect|Side effect]]'''
* '''[[Adverse event]]'''
* '''[[Adverse reaction]]'''
* '''[[Animal model]]'''
* '''[[Animal study]]'''
* '''[[Approved drugs]]'''
* '''[[Arm]]'''
* '''[[Audit report]]'''
* '''[[Audit trail]]'''
* '''[[Audit]]'''
* '''[[Baseline (medicine)|Baseline]]'''
* '''[[Bayesian inference|Bayesian]]''' approaches
* '''[[Best practice]]'''
* '''[[Bias]]'''
* '''[[Bioavailable]]'''
* '''[[Bioinformatics]]'''
* '''[[Biological drug]]'''
* '''[[Biometrics]]'''
* '''[[Biometry]]'''
* '''[[Biostatistics]]'''
* '''[[Blinded study]]'''
* '''[[Case report form]]'''
* '''[[Case report]]'''
* '''[[Case series]]'''
* '''[[Case-control study]]'''
* '''[[Clinical endpoint|Endpoint]]'''
* '''[[Clinical endpoint|Outcome]]'''
* '''[[Clinical investigator]]'''
* '''[[Clinical investigator|Investigator]]'''
* '''[[Clinical practice guidelines]]'''
* '''[[Clinical researcher]]'''
* '''[[Clinical series]]'''
* '''[[Clinical study]]''' or '''Clinical trial'''
* '''[[Clinical trial protocol]]'''
* '''[[Cohort (statistics)]]'''
* '''[[Cohort study]]'''
* '''[[Community-based clinical trial]] (CBCT)'''
* '''[[Comparator]]'''
* '''[[Compassionate use trial]]'''
* '''[[Compassionate use]]'''
* '''[[Complementary and alternative therapy]]'''
* '''[[compliance (regulation)|Compliance]]'''
* '''[[Confidentiality]] regarding trial participants'''
* '''[[Consecutive case series]]'''
* '''[[Content validity]]'''
* '''[[Contract Research Organization]]'''
* '''[[Contract]]'''
* '''[[Contraindication]]'''
* '''[[Control group]]'''
* '''[[Controlled trials]]'''
* '''[[Controlled trials|Controlled clinical trial]]'''
* '''[[Data and Safety Monitoring Board]]''' or '''Independent Data Monitoring Committee'''
* '''[[Diagnosis|Diagnostic]] trials'''
* '''[[Documentation]]'''
* '''[[Dose (biochemistry)#Effects are dose-dependent|Dose-dependent]]'''
* '''[[Dose (biochemistry)|Dose]]'''
* '''[[Dose-ranging study]]'''
* '''[[Double-blind study]]'''
* '''[[Double-blind|Blind]]'''
* '''[[Dropping out|Dropout]]'''
* '''[[Drug interaction|Drug–drug interaction]]'''
* '''[[Drug]]'''
* '''[[Efficacy]]'''
* '''[[Empirical]]'''
* '''[[Epidemiology]]'''
* '''[[Expanded access trial]]'''
* '''[[Expanded access]]'''
* '''[[Experimental drug]]'''
* '''[[Experimental techniques|Experimental]]'''
* '''[[Food and Drug Administration]] (FDA)'''
* '''[[Frequency probability|Frequentist methods]]'''
* '''[[Good clinical practice]]'''
* '''[[Healthcare professional|Clinician]]'''
* '''[[Historic cohort study]]'''
* '''[[Human subject research|Human subject]]'''
* '''[[Hypothesis]]'''
* '''[[In vitro]]'''
* '''[[In vivo]]'''
* '''[[Incidence (epidemiology)|Incidence]]'''
* '''[[Indication (medicine)|Indication]]'''
* '''[[Informed consent]]'''
* '''[[Inspection]]'''
* '''[[Institution]]'''
* '''[[Institutional Review Board]] (IRB)'''
* '''[[Inter-rater reliability]]'''
* '''[[Interaction]]''' (Qualitative & Quantitative)
* '''[[Interest group|Advocacy]] and [[support group]]s'''
* '''[[Interim analysis]]'''
* '''[[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}}
* '''[[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]] }}
* '''[[Intra-rater reliability]]'''
* '''[[Investigational drug]]'''
* '''[[Investigational New Drug]]'''
* '''[[Investigator's Brochure]]'''
* '''[[Levels of evidence]]'''
* '''[[Masked]]'''
* '''[[Medication]]'''
* '''[[Medicine]]'''
* '''[[Meta-analysis]]'''
* '''[[Monitoring in clinical trials|Monitoring]]'''
* '''[[National Cancer Institute|NCI]]''': {{citation | url = http://www.cancer.gov/dictionary/db_alpha.aspx | publisher = [[National Cancer Institute]] | title = Dictionary of Cancer Terms}}
* '''[[National Institutes of Health]]'''
* '''[[Natural history study]]'''
* '''[[New Drug Application]] (NDA)'''
* '''[[Nonconsecutive case series]]'''
* '''[[Observation]]'''
* '''[[Observational study]]'''
* '''[[Off-label]]'''
* '''[[Open label study]]'''
* '''[[Orphan drugs]]'''
* '''[[Outpatient]]'''
* '''[[Over-the-counter drug]]'''
* '''[[Patient advocate]]'''
* '''[[Peer review]]'''
* '''[[Pharmacokinetics]]'''
* '''[[Phase I clinical trials]]'''
* '''[[Phase II clinical trials]]'''
* '''[[Phase III clinical trials]]'''
* '''[[Phase IV clinical trial]]'''
* '''[[Physical examination|Clinical]]'''
* '''[[Pilot study]]'''
* '''[[Placebo effect]]'''
* '''[[Placebo-controlled studies|Placebo controlled study]]'''
* '''[[Placebo]]'''
* '''[[Population study]]'''
* '''[[Preclinical]]'''
* '''[[Preventive medicine|Prevention]]'''
* '''[[Prospective cohort study]]'''
* '''[[Quality Assurance]]'''
* '''[[Quality of life]] trials (or supportive care trials)'''
* '''[[Randomization]]'''
* '''[[Randomized clinical trial]]'''
* '''[[Recruitment|Recruiting]]'''
* '''[[Regimen]]'''
* '''[[Retrospective cohort study]]'''
* '''[[Retrospective]]'''
* '''[[Risk-benefit ratio]]'''
* '''[[Scientific control|Control]]'''
* '''[[Selection bias]]'''
* '''[[Single blind study]]'''
* '''[[sponsor (commercial)|Sponsor]]'''
* '''[[Standard Operating Procedures]]'''
* '''[[Standard treatment]]'''
* '''[[Standards of care]]'''
* '''[[Statistical significance]]'''
* '''[[Statistical significance|Significant]]'''
* '''[[Study endpoint]]'''
* '''[[t-test]]'''
* '''[[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}}
* '''[[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}}
* '''[[Toxicity]]'''
* '''[[Treatment IND]]'''
* '''[[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 }}
* '''Applicable regulatory requirement'''
* '''Approval''' (in relation to institutional review boards (IRBs))
* '''Audit certificate'''
* '''Blind review'''
* '''Clinical investigation'''
* '''Clinical Trial/Study Report'''
* '''Control animal'''
* '''Coordinating Committee'''
* '''Coordinating Investigator'''
* '''Direct Access'''
* '''Dose-limiting'''
* '''Dose-rate'''
* '''Double-dummy'''
* '''Eligibility criteria'''
* '''Enrolling'''
* '''Equivalence trial'''
* '''Essential Documents'''
* '''Evaluable disease'''
* '''Evaluable patients'''
* '''Follow-up'''
* '''Full analysis set'''
* '''Generalisability, Generalisation'''
* '''Global assessment variable'''
* '''Healthy control'''
* '''Historical control subject'''
* '''Impartial Witness'''
* '''Inclusion/exclusion criteria'''
* '''Independent Ethics Committee'''
* '''Informed consent document'''
* '''Intent to treat'''
* '''Interim Clinical Trial/Study Report'''
* '''Intervention group'''
* '''Intervention name'''
* '''Intervention'''
* '''Investigational'''
* '''Legally Acceptable Representative'''
* '''Maximum tolerated dose'''
* '''Monitoring Report'''
* '''Multicenter study'''
* '''Multidisciplinary opinion'''
* '''Multiplicity'''
* '''Non-inferiority trial'''
* '''Nonblinded'''
* '''Nonclinical Study'''
* '''Nonrandomized clinical trial'''
* '''Objective improvement'''
* '''Objective response'''
* '''Per protocol set''' (Valid Cases, Efficacy Sample, Evaluable Subjects Sample)
* '''Phase I/II trial'''
* '''Phase II/III trial'''
* '''Placebo therapy'''
* '''Predictive factor'''
* '''Prevention trials'''
* '''Preventive'''
* '''Primary endpoint'''
* '''Prospective'''
* '''Protocol Amendment'''
* '''Quality Control'''
* '''Recruitment status'''
* '''Regulatory Authorities'''
* '''Retrospective study'''
* '''Safety & tolerability'''
* '''Screening trials'''
* '''Serious Adverse Event'''
* '''Sham therapy'''
* '''Source Data'''
* '''Source Documents'''
* '''Sponsor-Investigator'''
* '''Statistical analysis plan'''
* '''Study type'''
* '''Subinvestigator'''
* '''Subject Identification Code'''
* '''Subject/Trial Subject'''
* '''Superiority trial'''
* '''Surrogate variable'''
* '''Test article'''
* '''Treatment effect'''
* '''Treatment emergent'''
* '''Treatment trials'''
* '''Trial Site'''
* '''Trial statistician'''
* '''Uncontrolled study'''
* '''Unexpected Adverse Drug Reaction'''
* '''Vulnerable Subjects'''
* '''Well-being of the trial subjects'''
 
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[[Category:Concept]]
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Latest revision as of 21:07, 6 November 2021

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