Glossary of clinical research

A

• Activities of daily living
• Adverse drug reaction
• Adverse effect
• Adverse event
• Adverse reaction
• Advocacy and support groups
• Animal model
• Animal study
• Applicable regulatory requirement
• Approval
• Approved drugs
• Arm
• Audit
• Audit certificate
• Audit report
• Audit trail

  B

• Baseline
• Bayesian approaches
• Best practice
• Bias
• Bioavailable
• Bioinformatics
• Biological drug
• Biometrics
• Biometry
• Biostatistics
• Blind
• Blind review
• Blinded study

  C

• Case report
• Case report form
• Case series
• Case-control study
• Clinical
• Clinical investigation
• Clinical investigator
• Clinical practice guidelines
• Clinical researcher
• Clinical series
• Clinical study or Clinical trial
• Clinical Trial/Study Report
• Clinician
• Cohort
• Cohort study
• Community-based clinical trial
• Comparator
• Compassionate use
• Compassionate use trial
• Complementary and alternative therapy
• Compliance
• Confidentiality regarding trial participants
• Consecutive case series
• Content validity
• Contract
• Contract Research Organization
• Contraindication
• Control
• Control animal
• Control group
• Controlled clinical trial
• Controlled trials
• Coordinating Committee
• Coordinating Investigator

  D

• Data and Safety Monitoring Board or Independent Data Monitoring Committee
• Diagnostic trials
• Direct Access
• Documentation
• Dose
• Dose-dependent
• Dose-limiting
• Dose-ranging study
• Dose-rate
• Double-blind study
• Double-dummy
• Dropout
• Drug
• Drug–drug interaction

  E

• Efficacy
• Eligibility criteria
• Empirical
• Endpoint
• Enrolling
• Epidemiology
• Equivalence trial
• Essential Documents
• Evaluable disease
• Evaluable patients
• Expanded access
• Expanded access trial
• Experimental
• Experimental drug

  F

• Follow-up
• Food and Drug Administration
• Frequentist methods
• Full analysis set

  G

• Generalisability, Generalisation
• Global assessment variable
• Good clinical practice

  H

• Healthy control
• Historic cohort study
• Historical control subject
• Human subject
• Hypothesis

  I

• Impartial Witness
• In vitro
• In vivo
• Incidence
• Inclusion/exclusion criteria
• Independent Ethics Committee
• Indication
• Informed consent
• Informed consent document
• Inspection
• Institution
• Institutional Review Board
• Intent to treat
• Interaction
• Inter-rater reliability
• Interim analysis
• Interim Clinical Trial/Study Report
• Intervention
• Intervention group
• Intervention name
• Intra-rater reliability
• Investigational
• Investigational drug
• Investigational New Drug
• Investigator
• Investigator's Brochure

  L

• Legally Acceptable Representative
• Levels of evidence

  M

• Masked
• Maximum tolerated dose
• Medication
• Medicine
• Meta-analysis
• Monitoring Report
• Monitoring
• Multicenter study
• Multidisciplinary opinion
• Multiplicity

  N

• National Institutes of Health
• Natural history study
• New Drug Application
• Nonblinded
• Nonclinical Study
• Nonconsecutive case series
• Non-inferiority trial
• Nonrandomized clinical trial

  O

• Objective improvement
• Objective response
• Observation
• Observational study
• Off-label
• Open label study
• Orphan drugs
• Outcome
• Outpatient
• Over-the-counter drug

  P

• Patient advocate
• Peer review
• Per protocol set
• Pharmacokinetics
• Phase I clinical trials
• Phase I/II trial
• Phase II clinical trials
• Phase II/III trial
• Phase III clinical trials
• Phase IV clinical trial
• Pilot study
• Placebo
• Placebo controlled study
• Placebo effect
• Placebo therapy
• Population study
• Preclinical
• Predictive factor
• Prevention
• Prevention trials
• Preventive
• Primary endpoint
• Prospective
• Prospective cohort study
• Clinical trial protocol
• Protocol Amendment

  Q

• Quality Assurance
• Quality Control
• Quality of life trials

  R

• Randomization
• Randomized clinical trial
• Recruiting
• Recruitment status
• Regimen
• Regulatory Authorities
• Retrospective
• Retrospective cohort study
• Retrospective study
• Risk-benefit ratio

  S

• Safety & tolerability
• Screening trials
• Selection bias
• Serious Adverse Event
• Sham therapy
• Side effect
• Significant
• Single blind study
• Source Data
• Source Documents
• Sponsor
• Sponsor-Investigator
• Standard treatment
• Standards of care
• Standard Operating Procedures
• Statistical analysis plan
• Statistical significance
• Study endpoint
• Study type
• Subinvestigator
• Subject Identification Code
• Subject/Trial Subject
• Superiority trial
• Surrogate variable

  T

• Test article
• Toxicity
• Treatment effect
• Treatment emergent
• Treatment IND
• Treatment trials
• Trial Site
• Trial statistician
• t-test

  U

• Uncontrolled study
• Unexpected Adverse Drug Reaction

  V

• Vulnerable Subjects

  W

• Well-being of the trial subjects