- Academic researcher
- Active-comparator arm
- Adaptive design
- Adeno-associated virus
- Adeno-associated virus gene therapy
- Adeno-associated virus vector capsid
- Adverse event
- Antisense oligonucleotide
- Arm
- Assay
- Attribute
- Basic research
- Basket protocol
- Bias
- Bioassay
- Biologic
- Biomarker
- Biopharmaceutical industry
- Biorepository
- Biosample
- Biotechnology
- Blinded observations
- Blinding
- Caregiver
- Caregiver perspective
- Caregiver preference
- Cell therapy
- Center for Biologics Evaluation and Research
- Center for Drug Evaluation and Research
- Clinical data
- Clinical investigator
- Clinical outcome
- Clinical outcome assessment
- Clinical relevance
- Clinical research
- Clinical research coordinator
- Clinical researcher
- Clinical study design
- Clinical study participant
- Clinical study protocol
- Clinical study sponsor
- Clinical trial
- Clinician-reported outcomes (ClinRO)
- Co-investigator (Co-I)
- Co-principal investigator (Co-PI)
- Common data element
- Community-based clinical trial (CBCT)
- Comparative effectiveness research (CER)
- Compliance
- Confidentiality
- Conflict of interest
- Contact registry
- Contract
- Contraindication
- Control arm
- Controlled access data sharing
- Core common data element
- CRISPR-Cas gene editing system
- CRISPR-Cas9
- Crossover study
- Data
- Data access
- Data analysis
- Data analysis plan
- Data cleaning
- Data element (DE)
- Data management
- Data management plan
- Data monitoring
- Data Monitoring Committee
- Data ownership
- Data quality
- Data sharing
- Data sharing agreement
- Data standard
- Data summary
- Database
- Dataset
- De-identified patient data
- De-identify
- Demographic data
- Diagnostic criteria
- Disease model
- Disease-specific common data element
- Domain-specific common data element
- Double-blind study
- Dropout statistical analysis
- Drug
- Drug-drug interaction
- Early phase 1
- Effectiveness
- Effectiveness study
- Efficacy
- Electronic medical record
- Eligibility criteria
- Endpoint
- Exclusion criteria
- Experimental arm
- Exploratory common data element
- Factorial assignment
- Fibroblast
- Follow-up duration
- Gene therapy
- Genome editing
- Group sequential trial
- Health consumer
- Health Insurance Portability and Accountability Act
- Imaging data
- Implementation study
- Inclusion criteria
- Induced pluripotent stem cell
- Informed consent
- Informed consent form
- Informed consent process
- Institutional Review Board
- Intervention
- Intervention model
- Investigational New Drug
- Investigational New Drug Application
- Investigational therapy
- Laboratory data
- Longitudinal study
- Marketing authorization
- Master protocol
- Median effective dose
- Medical device
- Multiple principal investigators
- Natural history study
- New Drug Application
- Newborn Screening
- Observational study
- Observational Study Monitoring Board
- Observer-reported outcomes
- Office of Orphan Products Development
- Open access data sharing
- Organoid
- Orphan drug
- Parallel study
- Pathophysiology
- Patient
- Patient advocate
- Patient engagement
- Patient experience data
- Patient investigator
- Patient perspective
- Patient preference
- Patient preference information
- Patient preference studies
- Patient-provided input
- Patient registry
- Patient-reported outcome
- Personally identifiable information
- Pharmaceutical Industry
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phases of Clinical Trials
- Physical functioning data
- Placebo
- Placebo comparator arm
- Placebo controlled study
- Placebo effect
- Platform protocol
- Population group
- Population-specific safety
- Preclinical studies
- Prevention trials
- Primary outcome measure
- Primary purpose
- Principal investigator
- Principal investigator
- Protected health information
- Protected personally identifiable information
- Proteomics
- Protocol-specific data elements
- Qualitative data
- Quantitative data
- Randomization
- Randomized controlled trial
- Real-world data
- Real-world evidence
- Registry
- Registry governance plan
- Registry platform
- Registry sustainability
- Regulator
- Reliability
- Representativeness
- Required common data element
- Results database
- RNA transcript
- Screening Trials
- Secondary outcome measure
- Serious adverse event
- Sex
- Sham comparator arm
- Single-blind study
- Single group study
- Small molecule drug
- Stakeholder
- Standardization
- Statistical analysis plans
- Statistical power analysis
- Statistical significance
- Study outcome measurement
- Subgroup
- Supplemental common data element
- Supplemental-highly recommended common data element
- Supportive care
- Supportive care trial
- Surrogate endpoint
- Survey data
- Therapeutic target
- Toxicity
- U.S. Food and Drug Administration
- Umbrella protocol
- Unblinding
- Underserved group
- Universal common data element
- Unmet medical need
- Validation
- Validity
