Regulatory & Documentation
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Read definitionProtocol Amendment
A protocol amendment is any change to an approved clinical trial protocol that is documented, justified, reviewed by the IRB/EC, and; depending on materiality; submitted to the regulatory authority before implementation.
Read definitionInformed Consent Form (ICF)
An informed consent form (ICF) is the document a clinical trial participant signs after a documented informed-consent discussion confirming they understand the study's purpose, procedures, risks, benefits, alternatives, and their rights as a research participant.
Read definitionStatistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
Read definitionClinical Study Report (CSR)
A Clinical Study Report (CSR) is the comprehensive scientific document, structured per ICH E3, that describes the conduct, methods, and results of a completed clinical trial and is submitted to regulatory authorities to support marketing applications.
Read definitionInvestigator Brochure (IB)
An Investigator's Brochure (IB) is the comprehensive document, updated at least annually, that summarizes all available clinical and non-clinical data on an investigational product, allowing investigators to assess the benefit-risk balance for trial participants.
Read definitionGood Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
Read definitionICH M11 (Common Protocol Template)
ICH M11 is the international harmonized standard, published by the International Council for Harmonisation, that defines a Common Protocol Template (CPT) and machine-readable Technical Specification for clinical trial protocols.
Read definitionICH E3 (Structure and Content of Clinical Study Reports)
ICH E3 is the international guideline that defines the required structure, content, and appendices of a Clinical Study Report submitted to support marketing authorization of an investigational medicinal product.
Read definitionMedical Writing (Clinical Documentation)
Medical writing in clinical research is the discipline of authoring scientifically accurate, regulatory-compliant documents; protocols, IBs, ICFs, SAPs, CSRs, DSURs, manuscripts; that communicate study rationale, methods, and findings to regulators, ethics committees, investigators, and the scientific community.
Read definitionIND Application (Investigational New Drug)
An Investigational New Drug (IND) application is the submission a sponsor files with the FDA to obtain authorization to ship an unapproved drug across state lines and to administer it to humans in a clinical trial.
Read definitionInstitutional Review Board (IRB) / Independent Ethics Committee (IEC)
An Institutional Review Board (IRB) in the U.S. or Independent Ethics Committee (IEC) outside the U.S. is an independent body that reviews and approves clinical trial protocols, informed consent, and recruitment materials to protect the rights, safety, and welfare of human research participants.
Read definitionDevelopment Safety Update Report (DSUR)
A Development Safety Update Report (DSUR) is an annual aggregate safety report that clinical trial sponsors submit to regulatory authorities, summarizing the cumulative safety profile of an investigational drug across all ongoing and completed trials worldwide; it is defined under ICH guideline E2F and is due within 60 calendar days of the data lock point.
Read definitionGood Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
Read definitionTrial Master File (TMF)
The Trial Master File (TMF) is the collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced, maintained by the sponsor and the investigator throughout and after the trial.
Read definitionInvestigational Product (IP)
An Investigational Product (IP) is the pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products with marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form.
Read definitionInvestigator-Initiated Trial (IIT)
An Investigator-Initiated Trial (IIT) is a clinical trial in which an academic or independent investigator (rather than a pharmaceutical or device sponsor) serves as the regulatory sponsor, holds the IND, and is responsible for protocol design, conduct, and reporting.
Read definitionSponsor (Clinical Trial)
A sponsor is the individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial, including regulatory submissions, IP supply, monitoring, safety reporting, and reporting of results.
Read definitionAccelerated Approval
Accelerated Approval is an FDA pathway that allows earlier approval of drugs treating serious conditions and filling unmet medical need on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, conditional on confirmatory post-marketing trials.
Read definitionBreakthrough Therapy Designation
Breakthrough Therapy Designation is an FDA program that expedites the development and review of drugs intended to treat serious or life-threatening conditions when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on a clinically significant endpoint.
Read definition
Sites & Operations
Site Selection (Clinical Trials)
Site selection is the process by which sponsors and CROs identify, evaluate, and choose the clinical trial sites best suited to enroll a given study, based on patient population access, investigator experience, operational capacity, regulatory standing, and historical performance.
Read definitionFeasibility Assessment
A feasibility assessment is a structured evaluation of whether a planned clinical trial can recruit enough eligible patients, at qualified sites, within the required timeline and budget, given a specific protocol design.
Read definitionSite Network (Clinical Trials)
A clinical trial site network is a curated, queryable database of clinical research sites with standardized profile data; including investigator credentials, therapeutic-area experience, prior trial performance, infrastructure, and regulatory standing; used to support site identification and selection.
Read definitionSite Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the on-site or remote evaluation conducted by a sponsor or CRO before site activation, to confirm that a candidate site has the personnel, facilities, processes, and patient access required to conduct the planned clinical trial in compliance with GCP.
Read definitionClinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Read definitionSite Initiation Visit (SIV)
A Site Initiation Visit (SIV) is the formal sponsor-led training and activation visit conducted at each clinical trial site immediately before the site is authorized to begin enrolling participants, typically following IRB approval and contract execution.
Read definitionClinical Trial Startup
Clinical trial startup is the set of activities between protocol finalization and first-patient-in (FPI), including regulatory submissions, IRB/IEC approvals, contract and budget execution, site selection and qualification, central lab and IRT setup, IP labeling, and site initiation visits.
Read definitionFirst Patient In (FPI)
First Patient In (FPI) is the milestone marking the date the first participant in a clinical trial is randomized or enrolled at any activated site, formally ending the startup phase and beginning the enrollment phase.
Read definitionContract Research Organization (CRO)
A Contract Research Organization (CRO) is a service organization that contracts with a pharmaceutical, biotech, or medical-device sponsor to perform some or all of the operational activities of a clinical trial, from protocol design through regulatory submission.
Read definitionPrincipal Investigator (PI)
A Principal Investigator (PI) is the qualified physician or other appropriately credentialed professional who has primary responsibility for the conduct of a clinical trial at an investigational site, including protocol adherence, participant safety, data integrity, and regulatory compliance.
Read definitionDecentralized Clinical Trial Elements (DCT Elements)
Decentralized clinical trial elements are individual components of a trial; eConsent, telemedicine visits, home nursing, direct-to-patient drug shipment, ePRO, wearables, local labs; that move trial activities from the central investigative site to the participant's home or community.
Read definitionSite Payments
Site payments are the financial disbursements a sponsor or CRO makes to a clinical trial site for services rendered; typically structured as per-patient visit payments, milestone payments (activation, FPI, LPLV), startup fees, IRB fees, and pass-through costs.
Read definition
Patient Recruitment
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Read definitionScreen Failure Rate
The screen failure rate is the percentage of patients who consent to be screened for a clinical trial but are subsequently found ineligible and not randomized.
Read definitionPatient Recruitment (Clinical Trials)
Patient recruitment is the end-to-end process of identifying, contacting, screening, and enrolling participants in a clinical trial, encompassing site-driven outreach, central recruitment campaigns, EHR-based identification, and patient-engagement workflows.
Read definitionElectronic Informed Consent (eConsent)
Electronic informed consent (eConsent) is the use of electronic systems and processes (multimedia, interactive content, electronic signature) to deliver informed consent information to clinical trial participants and to document their consent.
Read definitionScreening Visit
A screening visit is the in-clinic assessment at which a potential clinical trial participant is formally evaluated against the protocol's inclusion and exclusion criteria, typically through medical history, physical examination, lab work, and protocol-specific tests.
Read definitionPatient Recruitment Strategy
A patient recruitment strategy is the documented, multi-channel plan a sponsor or CRO uses to identify, engage, screen, and enroll the participants required to meet a clinical trial's enrollment timeline, sample size, and diversity goals.
Read definitionDiversity in Clinical Trials
Diversity in clinical trials is the inclusion of participants representing the demographic, racial, ethnic, age, sex, and socioeconomic populations expected to use the investigational product after approval, ensuring efficacy and safety findings generalize to the real-world patient population.
Read definitionScreen Failure
A screen failure is a clinical trial candidate who consents and undergoes screening but does not meet all inclusion criteria or meets one or more exclusion criteria, and is therefore not enrolled or randomized.
Read definitionEnrollment Rate
Enrollment rate is the average number of participants randomized per active site per month in a clinical trial, used as the principal operational metric of recruitment performance.
Read definition
Trial Design
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria are the protocol-defined conditions a person must satisfy (inclusion) or not exhibit (exclusion) to be eligible to enroll in a clinical trial.
Read definitionEndpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
Read definitionPhase 1, 2, 3, and 4 Clinical Trials
Clinical trials are conducted in four sequential phases: Phase 1 evaluates safety and pharmacokinetics in a small cohort; Phase 2 evaluates efficacy and dose; Phase 3 confirms efficacy and safety in large randomized populations to support marketing approval; Phase 4 monitors real-world safety and effectiveness post-approval.
Read definitionDecentralized Clinical Trial (DCT)
A decentralized clinical trial (DCT) is a clinical study in which some or all trial activities; recruitment, consent, dosing, monitoring, data capture; occur outside traditional brick-and-mortar sites, typically in the participant's home or community setting and supported by digital tools.
Read definitionClinical Trial Phases
Clinical trial phases are the sequential stages of human drug testing; Phase 1 evaluates safety in small healthy or patient cohorts, Phase 2 tests efficacy and dose in target patients, Phase 3 confirms efficacy and safety at scale to support marketing approval, and Phase 4 monitors long-term outcomes after approval.
Read definitionAdaptive Trial Design
An adaptive trial design is a clinical trial that uses pre-specified rules to modify aspects of the study (sample size, randomization ratio, dose, treatment arms, endpoints) based on accumulating interim data, without compromising scientific validity.
Read definitionPlatform Trial
A platform trial is a clinical trial that evaluates multiple investigational treatments against a common control under a single master protocol, with treatments added or dropped over time based on accumulating evidence.
Read definitionMaster Protocol
A master protocol is a single overarching trial protocol that supports the simultaneous evaluation of multiple drugs, multiple diseases, or multiple sub-populations, typically under one IND and shared operational infrastructure.
Read definitionBasket Trial
A basket trial is a clinical trial that tests one investigational therapy across multiple disease types (typically cancers) that share a common molecular biomarker or genetic alteration.
Read definitionUmbrella Trial
An umbrella trial is a clinical trial that evaluates multiple targeted therapies in patients with a single disease, stratified by molecular or genetic subtype, under one master protocol.
Read definitionBiomarker
A biomarker is a measurable biological characteristic (molecular, histologic, radiographic, or physiologic) used in clinical trials to indicate normal biology, disease state, treatment response, or prognosis.
Read definitionCompanion Diagnostic
A companion diagnostic is an in vitro device or imaging tool that provides information essential for the safe and effective use of a corresponding therapeutic product, typically by identifying patients eligible for treatment.
Read definitionRandomization
Randomization is the process of assigning clinical trial participants to treatment groups by chance, eliminating selection bias and producing comparable groups for unbiased estimation of treatment effects.
Read definitionBlinding (Masking)
Blinding (also called masking) is the practice of withholding information about treatment assignment from one or more parties in a clinical trial to prevent bias in outcome assessment, behavior, and analysis.
Read definitionPlacebo
A placebo is an inactive substance or sham intervention designed to be indistinguishable from the active investigational treatment, used as a control to isolate the specific effect of the intervention from non-specific effects.
Read definitionPrimary Endpoint
A primary endpoint is the pre-specified outcome measure on which a clinical trial's conclusions about efficacy or safety are principally based, used to power the sample size calculation and to test the trial's main hypothesis.
Read definitionSecondary Endpoint
A secondary endpoint is a pre-specified outcome measure that supports interpretation of the primary endpoint or evaluates additional treatment effects, but is not the principal basis for the trial's conclusion.
Read definitionSurrogate Endpoint
A surrogate endpoint is a biomarker or intermediate clinical measurement used as a substitute for a direct measure of how a patient feels, functions, or survives, that is reasonably likely to predict clinical benefit.
Read definitionExternal Control Arm
An external control arm is a comparator group constructed from data outside the current clinical trial; historical trial data, registry data, EHR data, or natural-history studies; used to contextualize results from a single-arm trial when randomization is infeasible.
Read definitionRare Disease Clinical Trial
A rare disease clinical trial is a study evaluating a therapy for a condition affecting fewer than 200,000 people in the U.S. (per the Orphan Drug Act) or fewer than 5 in 10,000 in the EU, characterized by small patient populations, geographic dispersion, and reliance on natural history data and external controls.
Read definition
Data & Quality
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
Read definitionEHR Integration (for Clinical Trials)
EHR integration in clinical research is the secure, standards-based connection between an electronic health record system and a clinical-trial application that enables eligibility screening, data abstraction, and source-data verification without manual transcription.
Read definitionReal-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
Read definitionIntention-to-Treat (ITT) Analysis
Intention-to-treat (ITT) analysis is a statistical principle requiring that all randomized participants be analyzed in the treatment group to which they were originally assigned, regardless of whether they completed, switched, or never received the assigned treatment.
Read definitionEstimand
An estimand is a precise description of the treatment effect a clinical trial aims to estimate, defined by five attributes: treatment, population, variable (endpoint), handling of intercurrent events, and population-level summary.
Read definitionSample Size Calculation
Sample size calculation is the statistical process of determining the number of participants required for a clinical trial to detect a specified treatment effect with a defined Type 1 error rate, statistical power, and assumptions about variability.
Read definitionInterim Analysis
An interim analysis is a pre-planned statistical evaluation of accumulating clinical trial data while the trial is ongoing, used to assess efficacy, futility, safety, or to trigger sample-size adaptation.
Read definitionData Monitoring Committee (DMC)
A Data Monitoring Committee (DMC), also called a Data and Safety Monitoring Board (DSMB), is an independent group of experts that periodically reviews accumulating trial data to safeguard participant safety, study integrity, and scientific validity.
Read definitionAdverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical product, regardless of whether it is considered related to the product.
Read definitionSerious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly, or is an important medical event per investigator judgment.
Read definitionPharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, across both clinical trial and post-marketing settings.
Read definitionElectronic Data Capture (EDC)
Electronic Data Capture (EDC) is the system used to collect, manage, and store clinical trial data electronically via electronic case report forms (eCRFs), replacing paper-based data collection.
Read definitionCDISC (SDTM and ADaM)
CDISC (Clinical Data Interchange Standards Consortium) is the global non-profit that develops the data standards required by FDA and PMDA for regulatory submission, including SDTM (Study Data Tabulation Model) for raw observed data and ADaM (Analysis Data Model) for analysis-ready datasets.
Read definitionElectronic Patient-Reported Outcomes (ePRO)
Electronic Patient-Reported Outcomes (ePRO) are clinical trial data collected directly from participants via electronic devices (smartphone apps, tablets, web portals) on symptoms, function, quality of life, and treatment experience, without interpretation by a clinician.
Read definitionCase Report Form (CRF)
A Case Report Form (CRF) is the printed, optical, or electronic document designed to record all protocol-required information about each clinical trial participant, supporting regulatory submission and statistical analysis.
Read definitionSource Data Verification (SDV)
Source Data Verification (SDV) is the process of comparing data entered into the case report form against the original source documents (medical records, lab reports, imaging) to confirm that the recorded data are accurate, complete, and verifiable.
Read definitionReal-World Evidence (RWE)
Real-World Evidence (RWE) is clinical evidence about the use, safety, and effectiveness of a medical product derived from analysis of Real-World Data (RWD); EHRs, claims, registries, wearables; collected outside the controlled environment of a randomized clinical trial.
Read definition