Clinical Research Glossary: Key Terms You Need to Know

Navigating the world of clinical research can be complex, especially with the array of specialized terminology. To help, we’ve compiled a clinical research glossary of some of the most commonly used terms in clinical trials. This glossary is designed to provide clear and concise explanations, ensuring a better understanding for professionals, volunteers and stakeholders involved in clinical trials.

21 CFR Part 11
Part of the Code of Federal Regulations, 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

Abbreviated New Drug Application (ANDA)
A submission to the FDA seeking approval to market a generic drug. ANDAs must show the generic drug is equivalent to the brand-name drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use.

Biologic License Application (BLA)
A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.

Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Biosimilars are Biologic medical products that are almost identical copies of an original product manufactured by a different company, introduced after the original product’s patent expires. Biological medicines offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease and cancers.

Clinical Trial
Clinical trials are research studies that are performed to evaluate the safety and efficacy of a medical, surgical, or behavioral intervention, or diagnostic method. The intervention is generally compared with the current standard of treatment for the condition being studied.

Protocol
The protocol is the thorough, written description of the objective(s), design, methodology, statistical consideration, and organization of a trial. The protocol may also contain relevant scientific background to justify the trial.

Informed Consent
Informed consent is a process by which a participant voluntarily confirms their willingness to participate in a particular trial, after being informed of all aspects of the trial that are relevant to their decision. This process includes signing a document that explains the trial’s purpose, duration, required procedures, risks, and benefits.

Informed Consent Document (ICD)
A document that provides detailed information about a clinical trial to prospective participants, including its purpose, risks, benefits, and procedures.

Informed Consent Form (ICF)
A document used to provide information about a clinical trial to potential participants, ensuring they understand the study and can make an informed decision about participation.

Adverse Event (AE)
An adverse event is any undesired or harmful effect experienced by a participant during a clinical trial, which may or may not be related to the investigational product. Monitoring and reporting AEs are crucial for assessing the safety of the intervention.

Randomization
Randomization is the process of assigning participants to different groups (e.g., treatment or control) by chance, rather than by choice. This helps to minimize bias and ensure the groups are comparable.

Placebo
A placebo is an inactive substance or treatment that has no therapeutic effect, used as a control in testing new drugs. Placebos help to determine the effectiveness of the investigational product by comparing outcomes.

Double-Blind Study
A double-blind study is a trial design in which neither the participants nor the investigators know which participants are receiving the investigational product and which are receiving a placebo or standard treatment. This design helps to prevent bias.

Endpoint
An endpoint is a primary outcome measure used to judge the effectiveness of a treatment. Endpoints are typically predefined and can include measures like survival rates, symptom improvement, or biomarker changes.

Institutional Review Board (IRB)
An Institutional Review Board is a committee that reviews and approves the ethical aspects of a clinical trial protocol to ensure the protection of participants’ rights and welfare. They oversee the trial’s conduct and safeguard ethical standards.

Good Clinical Practice (GCP)
Good clinical practice is an ethical and quality standard that follows the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It enforces regulations for the designing, conducting, monitoring, auditing, recording, analysis, and reporting of clinical trials that involve the participation of human subjects. All investigators and their staff are expected to comply with Good Clinical Practice.

Good Laboratory Practices (GLP)
Good laboratory practices (GLP) provide a framework within which non-clinical and laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP is a quality system used to assure that the data submitted to the regulatory authorities are an accurate reflection of the results obtained during the study. GLP is most often used during the preclinical trials of the drug development process.

Bioanalytical Lab
A bioanalytical lab specializes in analyzing biological samples for the presence and concentration of drugs, metabolites, and biomarkers. These labs use advanced technologies and methodologies, such as liquid chromatography-mass spectrometry (LC-MS) and immunoassays, to provide accurate and reliable data. Bioanalytical labs play a crucial role in clinical research by supporting pharmacokinetic and pharmacodynamic studies, ensuring the integrity of data collected during clinical trials, and helping to determine the safety and efficacy of new therapies

Blinding (Masking)
Blinding or masking is a method used to prevent bias in research. In a single-blind study, the participant does not know whether they are receiving the investigational product or the placebo. In a double-blind study, neither the participant nor the researchers know.

Pharmacokinetics (PK)
Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and excreted in the body. PK studies help determine the dosage and frequency of administration.

Pharmacodynamics (PD)
Pharmacodynamics refers to the study of the biochemical and physiological effects of drugs and their mechanisms of action. It involves the interaction between the drug and its target cells or tissues..

Control Group
A control group is a group of participants in a clinical trial who receive a placebo or standard treatment, rather than the investigational product. This group is used as a benchmark to compare the effects of the investigational product.

Clinical Lab
A clinical lab performs diagnostic tests on patient samples, such as blood, urine, and tissue, to support medical decision-making and clinical research. These labs use a variety of advanced technologies and methodologies to analyze samples for disease markers, pathogens, genetic information, and other health indicators. Clinical labs play a crucial role in healthcare by providing accurate and timely data that informs diagnosis, treatment plans, and monitoring of patient health. In clinical research, they support trials by providing essential data on biomarkers, disease progression, and treatment effects, ensuring the reliability and validity of study results.

CRA (Clinical Research Associates)
Professionals who monitor clinical trials and ensure that they are conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and regulatory requirements.

Efficacy
Efficacy is the ability of an intervention or drug to produce the desired therapeutic effect under controlled conditions. It is typically assessed during clinical trials.

Safety Monitoring Board (SMB)
A Safety Monitoring Board is an independent group of experts that monitors participant safety and treatment efficacy data while a clinical trial is ongoing. They have the authority to recommend modifications or termination of the trial based on their findings.

Investigator’s Brochure (IB)
The Investigator’s Brochure is a comprehensive document summarizing the clinical and non-clinical data about an investigational product. It is provided to the clinical investigators and ethics committees to help assess the study’s risks and benefits.

Clinical Endpoint Committee (CEC)
A Clinical Endpoint Committee is an independent group of experts who review and validate clinical endpoints in a trial to ensure consistency and accuracy in the reported outcomes.

Data and Safety Monitoring Plan (DSMP)
A Data and Safety Monitoring Plan outlines the processes for monitoring and ensuring the safety of participants and the integrity of the data in a clinical trial. It includes plans for adverse event reporting and interim analysis.

Adverse Drug Reaction (ADR)
An adverse drug reaction is any unintended, harmful reaction to a drug administered at normal doses. It is crucial to monitor and report ADRs during clinical trials to ensure participant safety.

Audit Trail
An audit trail is a chronological record of changes or data entries in a clinical trial, which can be used to trace back steps, verify data integrity, and ensure compliance with regulatory requirements.

Baseline Characteristics
Baseline characteristics refer to the initial set of data collected at the beginning of a clinical trial, including demographics, medical history, and other relevant factors. These characteristics are used to ensure the comparability of treatment groups.

Biomarker
A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Biomarkers are used to monitor and predict health conditions or responses to treatment.

Blinded Data Review
Blinded data review is a process where data is reviewed without knowledge of the treatment assignments to prevent bias. This process ensures objective assessment of trial outcomes.

Case Report Form (CRF)
A Case Report Form is a document used in clinical research to collect data from each participating patient. CRFs are essential for recording all protocol-required information for each participant in a clinical trial. An eCRF (electronic case report form) is a digital questionnaire that is used to collect data about a clinical study and research participants. The data collected in eCRFs is what biostatisticians analyze to draw a conclusion from a study.

Cardiovascular Disease CRO
A Cardiovascular Disease Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on cardiovascular diseases and related conditions affecting the heart and circulatory system. These CROs offer tailored services to support cardiovascular research, including study design, patient recruitment, regulatory support, data management, and analysis. Cardiology CROs play a vital role in advancing the understanding and treatment of conditions such as coronary artery disease, heart failure, arrhythmias, hypertension, and peripheral vascular disease. By facilitating the development of new therapies and interventions, these CROs contribute to reducing the burden of cardiovascular disease and improving outcomes for patients worldwide.

Cell & Gene Therapy CRO
A Cell & Gene Therapy Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on cell and gene therapies. These CROs offer tailored services to support research in areas such as gene editing, cell transplantation, immunotherapy, and regenerative medicine. Services provided by Cell & Gene Therapy CROs include study design, patient recruitment, regulatory support, data management, and analysis, with a focus on advancing the understanding and treatment of genetic and cellular disorders, cancer, and other diseases.

Centralized Monitoring
A method of clinical trial oversight where monitoring activities are conducted from a remote location rather than on-site.

Clinical Research Coordinator (CRC)
A Clinical Research Coordinator is a professional responsible for overseeing the daily operations of clinical trials, including recruiting participants, collecting data, and ensuring compliance with the study protocol.

Clinical Research Organization (CRO)
In the context of the clinical research and pharmaceutical industries, both “Clinical Research Organization” (CRO) and “Contract Research Organization” (also CRO) are used interchangeably. A Contract Research Organization (CRO) provides support to the pharmaceutical, biotechnology, and medical device sectors by offering a range of outsourced research services. These services can include preclinical research, clinical trial management, biostatistics, data management, regulatory affairs, and post-marketing surveillance. The primary role of a CRO is to manage the clinical trials and other research activities required for drug development, ensuring compliance with regulatory standards while optimizing the process for efficiency and cost-effectiveness.

Contract Development and Manufacturing Organization (CDMO)
A CDMO provides comprehensive services in drug development and manufacturing for pharmaceutical companies. These organizations support the entire lifecycle of a drug, from initial development through to commercial production. Services offered by CDMOs include formulation development, process development, clinical and commercial-scale manufacturing, packaging, and regulatory support. By outsourcing to CDMOs, pharmaceutical companies can leverage specialized expertise, advanced technologies, and scalable operations to accelerate drug development timelines and ensure high-quality production.

Clinical Trial Management System (CTMS)
A Clinical Trial Management System (CTMS) is a software solution designed to streamline and manage the various aspects of clinical trials. It integrates and automates the processes related to planning, tracking, and managing clinical trials, including study design, site selection, patient recruitment, data collection, regulatory compliance, and reporting.

ClinOps (Clinical Operations)
The segment of clinical research responsible for the execution of clinical trials, including monitoring and compliance with protocols.

Cohort
A cohort is a group of individuals with shared characteristics who are followed over time in a clinical trial. Cohorts can be used to study the effects of interventions or exposures on outcomes.

Cross-Over Study
A cross-over study is a type of clinical trial in which participants receive multiple treatments in a specific sequence. Each participant acts as their own control, reducing variability and improving the reliability of results.

Data Lock
Data lock refers to the point in a clinical trial when all data has been collected and no further changes can be made to the dataset. This stage precedes the final data analysis..

Data Management
The process of collecting, processing, and analyzing data collected during a clinical trial.

Data Management Plan (DMP)
A comprehensive plan that outlines how data will be handled both during and after a clinical trial.

Dermatology CRO
A Dermatology Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on skin-related diseases and conditions. These organizations provide comprehensive services, including study design, patient recruitment, regulatory support, data management, and analysis, tailored specifically to the field of dermatology. Dermatology CROs leverage their expertise and resources to navigate the complexities of dermatology research, ensuring efficient trial conduct, regulatory compliance, and ultimately contributing to the development of new treatments and therapies for skin disorders.

Ethics Committee (EC)
An Ethics Committee is a body responsible for reviewing and approving the ethical aspects of a clinical trial to ensure the protection of participants’ rights and welfare. Similar to an Institutional Review Board (IRB).

Electronic Data Capture (EDC)
Electronic Data Capture (EDC) refers to the process of collecting clinical trial data electronically using specialized software systems. Instead of traditional paper-based methods, where data is manually recorded and transcribed, EDC systems allow researchers to directly enter and manage data electronically, streamlining the data collection process and improving accuracy and efficiency

Exploratory Analysis
Exploratory analysis involves examining data without pre-specified hypotheses to discover patterns, trends, or unexpected relationships. It can generate new hypotheses for further study.

Exclusion/Inclusion Criteria
The inclusion and exclusion criteria are a set of eligibility criteria that determine if a participant may be enrolled in a study. The inclusion criteria determine the characteristics a person must meet to be able to participate, while the exclusion criteria determine the characteristics that prevent a person from participating.

Feasibility Study
A feasibility study is a preliminary investigation to assess whether a proposed clinical trial is practical and likely to succeed. It considers factors like participant recruitment, resource availability, and potential obstacles.

Fit-for-Purpose Initiative
The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of these types of drug development tools (DDTs) and the inability to provide formal qualification, a designation of ‘fit-for-purpose’ (FFP) has been established. A DDT is deemed FFP based on the acceptance of the proposed tool following a thorough evaluation of the information provided. The FFP determination is made publicly available in an effort to facilitate greater utilization of these tools in drug development programs.

Food and Drug Administration (FDA)
A federal agency of the United States Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products, and cosmetics.

Full-service CRO
A Full-Service Clinical Research Organization (CRO) offers a comprehensive range of services to support the planning, execution, and management of clinical trials for pharmaceutical, biotechnology. A full-service CRO provides end-to-end support for clinical research programs, from study design and regulatory strategy to study execution, data analysis, and regulatory submissions. By offering a comprehensive suite of services, full-service CROs help sponsors streamline the drug development process, mitigate risks, and accelerate the delivery of new therapies to patients in need.

Gastroenterology CRO
A Gastroenterology Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on gastrointestinal (GI) diseases and disorders. These CROs provide specialized services tailored to gastroenterology research, including study design, patient recruitment, regulatory support, data management, and analysis. Gastroenterology CROs play a critical role in advancing the understanding and treatment of GI conditions such as inflammatory bowel disease (IBD), gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), liver diseases, and gastrointestinal cancers. By facilitating the development of new therapies and interventions, Gastroenterology CROs contribute to improving patient outcomes and quality of life for individuals affected by GI disorders.

Gynecology CRO
A Gynecology Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on women’s health and gynecological conditions. These CROs provide tailored services to support research in areas such as menstrual disorders, fertility treatments, reproductive health, and gynecological cancers. Services offered by Gynecology CROs include study design, patient recruitment, regulatory support, data management, and analysis, with a focus on addressing the unique physiological and hormonal aspects of women’s health. Gynecology CROs play a vital role in advancing the understanding and treatment of gynecological conditions, contributing to improved healthcare outcomes and quality of life for women worldwide.

Hematology CRO
Hematology-focused Clinical Research Organizations (CROs) specialize in conducting clinical trials for blood-related disorders, leveraging deep scientific expertise and robust operational capabilities.

Infectious Disease & Vaccines CRO
An Infectious Disease & Vaccines Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on infectious diseases and vaccine development. These CROs provide comprehensive services tailored to infectious disease research, including study design, patient recruitment, regulatory support, data management, and analysis. Additionally, they offer expertise in vaccine development, from preclinical research to clinical trials and post-marketing studies. Infectious Disease & Vaccines CROs play a crucial role in advancing the understanding of infectious diseases such as HIV/AIDS, malaria, tuberculosis, influenza, and emerging pathogens, as well as in evaluating the safety and efficacy of vaccines against infectious diseases. By facilitating the development of new vaccines and treatments, these CROs contribute to global efforts to prevent and control infectious diseases and protect public health.

Interim Analysis
Interim analysis is an evaluation of trial data conducted at predefined points before the trial’s conclusion. It helps to monitor safety and efficacy, and can lead to early trial termination if necessary.

Investigational New Drug (IND)
An Investigational New Drug is a drug or biologic that has not yet been approved for general use by regulatory authorities and is under investigation in clinical trials. An IND application must be submitted to regulatory agencies before starting human trials.

Investigational Product (IP)
An Investigational Product is any pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. It includes products already available on the market but being studied for new indications.

Metabolic Diseases CRO
A Metabolic Diseases Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on metabolic disorders and related conditions affecting metabolism and hormonal regulation. These CROs offer tailored services to support research in areas such as diabetes, obesity, lipid disorders, and metabolic syndrome. Services provided by Metabolic Diseases CROs include study design, patient recruitment, regulatory support, data management, and analysis, with a focus on advancing the understanding and treatment of metabolic disorders.

Monitoring Plan
A monitoring plan outlines the procedures for overseeing the progress and conduct of a clinical trial. It ensures compliance with the protocol, GCP, and regulatory requirements.

Multi-Center Trial
A multi-center trial is a clinical trial conducted at several locations simultaneously. It enhances the generalizability of the findings and accelerates participant recruitment.

Musculoskeletal CRO
A Musculoskeletal Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on diseases and conditions affecting the musculoskeletal system, including bones, joints, muscles, ligaments, and tendons. These CROs offer tailored services to support musculoskeletal research, including study design, patient recruitment, regulatory support, data management, and analysis. Musculoskeletal CROs play a crucial role in advancing the understanding and treatment of conditions such as osteoarthritis, rheumatoid arthritis, osteoporosis, sports injuries, and musculoskeletal trauma. By facilitating the development of new therapies and interventions, these CROs contribute to improving outcomes and quality of life for individuals affected by musculoskeletal disorders.

Nephrology CRO
A Nephrology Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on kidney-related diseases and conditions. These CROs provide specialized services to support nephrology research, including study design, patient recruitment, regulatory support, data management, and analysis. Nephrology CROs play a critical role in advancing the understanding and treatment of conditions such as chronic kidney disease, kidney transplantation, renal failure, and kidney-related complications of other diseases. By facilitating the development of new therapies and interventions, Nephrology CROs contribute to improving outcomes and quality of life for patients with kidney disorders.

Neuroscience CRO
A Neuroscience Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on neurological disorders and conditions affecting the brain, spinal cord, and nervous system. These CROs offer a range of specialized services tailored to neuroscience research, including study design, patient recruitment, regulatory support, data management, and analysis. Neurology & CNS CROs leverage their expertise in neurology and neuropharmacology to facilitate the development of novel therapies, diagnostics, and interventions for neurological diseases such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and others.

Observational Study
An observational study involves monitoring participants without intervening or altering their environment. It helps to identify correlations and generate hypotheses for further investigation.

Open-Label Study
An open-label study is a type of clinical trial in which both the researchers and participants know which treatment is being administered. It contrasts with blinded studies and is often used when blinding is impractical.

Oncology CRO
Oncology-focused Clinical Research Organizations (CROs) specialize in the complex and rapidly evolving field of cancer research. These CROs offer expertise in designing, managing, and executing clinical trials for oncology therapeutics, leveraging advanced technologies and scientific knowledge to navigate the challenges specific to oncology studies.

Ophthalmology CRO
Ophthalmology-focused Clinical Research Organizations (CROs) specialize in managing clinical trials for eye-related diseases and conditions. These CROs leverage specialized expertise, advanced technologies, and comprehensive service offerings to support the unique challenges of ophthalmology research.

Orphan Drug
An orphan drug is a pharmaceutical agent developed to treat rare diseases or conditions. Regulatory agencies provide incentives for developing orphan drugs due to the limited market potential.

Orthopedics & Spine CRO
An Orthopedics & Spine Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on orthopedic and spinal diseases and conditions. These CROs offer tailored services to support research in areas such as joint replacement, spinal fusion, orthopedic trauma, spinal deformities, and musculoskeletal disorders.

Pharmacovigilance
Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. It ensures drug safety throughout its lifecycle.

Phase I Trial
A Phase I trial is the first stage of clinical testing in humans, focusing on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of an investigational product in a small group of healthy volunteers or patients.

Phase II Trial
A Phase II trial aims to evaluate the efficacy and safety of an investigational product in a larger group of patients. It helps to determine the optimal dose and further assess safety.

Phase III Trial
A Phase III trial is a large-scale study designed to confirm the efficacy and safety of an investigational product in a broad patient population. It provides the primary data for regulatory approval.

Phase IV Trial
A Phase IV trial, or post-marketing study, monitors the safety and efficacy of an approved drug in the general population. It helps to identify rare or long-term adverse effects and refine the product’s use.

Phase-1 Unit
A Phase-1 Unit is a specialized facility dedicated to conducting Phase-1 clinical trials, which are the first stage of testing new drugs or treatments in humans. These units are designed to handle early-phase studies, focusing on assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of investigational drugs. Phase-1 Units are equipped with advanced medical and monitoring equipment and staffed by experienced healthcare professionals to ensure the safety and well-being of participants. They play a critical role in drug development by providing essential early data on a new treatment’s effects, guiding subsequent phases of clinical research.

Placebo-Controlled Trial
A placebo-controlled trial is a clinical study in which the investigational product is compared to a placebo. It helps to isolate the treatment’s effect from the placebo effect.

Preclinical Study
A preclinical study is research conducted before human trials to assess the safety and efficacy of a drug or intervention in laboratory or animal models. It provides the basis for initiating clinical trials.

Principal Investigator (PI)
The Principal Investigator is the lead researcher responsible for the conduct of a clinical trial at a study site. The PI ensures the study is conducted according to the protocol and regulatory requirements.

Protocol Deviation
A protocol deviation is any change or departure from the study protocol that occurs without prior approval. It must be documented and reported to ensure the integrity of the trial.

Psychiatry CRO
A Psychiatry Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on mental health disorders and psychiatric conditions. These CROs offer tailored services to support research in areas such as depression, anxiety disorders, schizophrenia, bipolar disorder, and others.

Pulmonology CRO
A Pulmonology Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on respiratory diseases and conditions affecting the lungs and airways. These CROs provide specialized services tailored to pulmonology research, including study design, patient recruitment, regulatory support, data management, and analysis. Pulmonology CROs play a crucial role in advancing the understanding and treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, lung cancer, and others.

National Cancer Institute (NCI)
The National Cancer Institute is a federal agency within the National Institutes of Health (NIH) that coordinates the United States’ national cancer research program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer.

National Institute of Health (NIH)
The National Institutes of Health is the primary agency of the United States government responsible for biomedical and public health research. It comprises 27 institutes and centers, including the National Cancer Institute (NCI), National Institute of Mental Health (NIMH), and National Institute on Aging (NIA).

Patch Testing
Patch testing is a diagnostic test used to identify allergens or irritants that may cause allergic contact dermatitis, a delayed hypersensitivity reaction of the skin. It involves applying small amounts of suspected allergens to the skin surface under occlusion and assessing for localized reactions after 48 to 72 hours.

Pediatrics CRO
A Pediatrics Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on pediatric populations. These CROs provide specialized services tailored to pediatric research, including study design, patient recruitment, regulatory support, data management, and analysis, with a focus on the unique considerations of pediatric patients. Pediatrics CROs play a crucial role in advancing the understanding and treatment of childhood diseases, developmental disorders, and pediatric-specific conditions. By facilitating the development of new therapies and interventions specifically for children, Pediatrics CROs contribute to improving pediatric healthcare outcomes and ensuring the safety and efficacy of treatments for the youngest patient populations.

Quality Assurance (QA)
Quality Assurance (QA) in clinical research involves the systematic monitoring and evaluation of processes to ensure that trials are conducted in compliance with regulatory standards and protocols. QA activities include auditing, training, SOP development, and risk assessment, aimed at maintaining the integrity and reliability of data.

Quality Control (QC)
Quality Control (QC) refers to the operational techniques and activities used to ensure that products or services meet specified quality standards. In clinical research, QC involves monitoring and verifying data collection, analysis, and reporting processes to identify and correct errors or deviations.

Randomized Controlled Trial (RCT)
A Randomized Controlled Trial is a study in which participants are randomly assigned to different groups to receive various interventions. RCTs are considered the gold standard for evaluating the efficacy of interventions.

Rare Diseases CRO
A Rare Diseases Clinical Research Organization (CRO) specializes in managing and conducting clinical trials focused on rare and orphan diseases. These CROs provide specialized services to support research in areas such as rare genetic disorders, autoimmune diseases, and other uncommon conditions. Services offered by Rare Diseases CROs include study design, patient recruitment from geographically dispersed populations, regulatory support for orphan drug designations, data management, and analysis. By conducting clinical trials for rare diseases, these CROs contribute to improving outcomes and quality of life for patients with these often-overlooked conditions.

Real-World Evidence (RWE)
Real-World Evidence refers to clinical evidence derived from real-world data, including electronic health records, claims data, and patient registries. It complements data from clinical trials.

RECIST
RECIST (Response Evaluation Criteria in Solid Tumors) is a set of standardized criteria used to assess tumor response in cancer clinical trials. RECIST criteria define specific measurements and thresholds for categorizing tumor response as complete response, partial response, stable disease, or progressive disease.

Regulatory Affairs
Regulatory Affairs involves ensuring that a company complies with all of the regulations and laws pertaining to its business. In clinical research, it involves preparing and submitting documents to regulatory authorities.

Sample Size
Sample size refers to the number of participants included in a study. Adequate sample size ensures the study has enough power to detect meaningful differences.

Screening
Screening involves testing participants to determine their eligibility for a clinical trial. It ensures that only suitable candidates are enrolled in the study.

Serious Adverse Event (SAE)
A Serious Adverse Event is any undesirable experience associated with the use of a medical product that results in death, life-threatening events, hospitalization, or significant disability.

Single-Blind Study
A single-blind study is a clinical trial design in which the participants do not know which treatment they are receiving, but the researchers do. It helps to prevent bias in participants’ responses.

Site Initiation Visit (SIV)
A Site Initiation Visit is a meeting conducted by the sponsor or CRO at the study site to review the protocol, procedures, and requirements with the site staff before the start of the trial.

Source Data Verification (SDV)
Source Data Verification is the process of ensuring that data collected in the case report forms accurately reflects the source data (e.g., medical records). It ensures data integrity and accuracy.

Sponsor
A sponsor is an individual, company, institution, or organization responsible for initiating, managing, and financing a clinical trial. The sponsor ensures the trial is conducted according to regulatory requirements.

Standard Operating Procedures (SOPs)
Standard Operating Procedures are detailed, written instructions to achieve uniformity in performing specific functions. SOPs ensure consistency and compliance in clinical trial conduct.

Statistical Analysis Plan (SAP)
A Statistical Analysis Plan is a detailed, written description of the statistical methods and procedures to be used in analyzing the data from a clinical trial. It is developed before data analysis begins.

Stratification
Stratification involves dividing participants into subgroups based on specific characteristics (e.g., age, gender) before randomization. It ensures that these characteristics are evenly distributed across treatment groups.

Study Coordinator
A Study Coordinator is a professional who assists in the management and coordination of clinical trials. They handle administrative tasks, participant recruitment, and data collection.

Sub-Investigator
A Sub-Investigator is a member of the research team who assists the Principal Investigator in conducting a clinical trial. They perform specific tasks as delegated by the PI.

Surrogate Endpoint
A surrogate endpoint is a biomarker or other measure used as a substitute for a clinical endpoint. It is expected to predict the effect of the treatment on the clinical endpoint..

Trial Master File (TMF)
The Trial Master File is a collection of essential documents that enable the conduct and management of a clinical trial. It is maintained by the sponsor and ensures compliance with regulatory requirements. eTMF is a type of software that provides a digital space for creating, tracking, and storing the Trial Master File (TMF).

Urology CRO
A Urology Clinical Research Organization (CRO) specializes in managing clinical trials for urological disorders. They offer services including study design, patient recruitment, regulatory support, data management, and analysis, focusing on improving treatments for conditions affecting the urinary tract and male reproductive system.


References:

  1. ClinicalTrials.gov Glossary of Common Site Terms: https://clinicaltrials.gov/ct2/about-studies/glossary
  2. World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Glossary: https://www.who.int/clinical-trials-registry-platform/glossary
  3. US Food and Drug Administration (FDA) Glossary of Terms: https://www.fda.gov/safety/reporting-serious-problems-fda/glossary-terms
  4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Glossary: https://www.ich.org/page/efficacy-guidelines#Glossary
  5. National Institutes of Health (NIH) Clinical Research Glossary: https://clinicalcenter.nih.gov/training/training/rntp/glossary.html
  6. European Medicines Agency (EMA) Glossary: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-glossary-terms-used-european-medicines-agency_en.pdf
  7. European Medicines Agency (EMA): https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview

About Lambda: Lambda Therapeutic Research is a leading full-service Global Clinical Research Organization (CRO) headquartered in Ahmedabad (India), with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Las Vegas (USA) and Pittsburgh (USA). Lambda provides comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. With a commitment to excellence, our experienced team of 1500+ professionals utilizes cutting-edge technology and innovative solutions to provide a full spectrum of clinical trial solutions spanning from preclinical research to post-marketing studies. Over two decades of dedication to excellence has earned us numerous accolades, including the distinction of ‘Best Indian CRO’ by Frost & Sullivan (USA) and the coveted title of ‘Great Indian Workplace’ by UBS Transformance. Lambda Therapeutic Research has been recently honored with the ‘Regulatory Excellence’ Award at the CPHI Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.

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