Keyword	Definition
Adaptive Clinical Trial	A trial design that allows modifications to some aspects of the trial after its initiation without undermining the validity and integrity of the trial, making it possible to discover and rectify inappropriate assumptions in trial designs, lower development costs and reduce the time to market.
Clinical Data Interchange Standards Consortium (CDISC)	A global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
Clinical Data Management	The management of data from clinical trials.
Clinical Outcome Assessment (COA)	A Clinical Outcome Assessment (COA) directly or indirectly measures how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit.  COAs include Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs) and Observer Reported Outcomes (ObsROs).
Clinician Reported Outcome (CRO)	A report about a patient’s health condition or treatment, which is collected by a clinician evaluating a patient and recording the results.
Clinical Research Coordinator (CRC)	An employee of a medical facility certified as an investigative site, who is responsible for conducting clinical trials using good clinical practice (GCP) under the direction of the Principal Investigator (PI). The responsibilities of the CRC include conducting the informed consent process and ensuring compliance with the protocol.
Cognitive Interview (aka Cognitive Debriefing)	A qualitative research tool used to determine whether concepts and items are understood by patients in the same way that instrument developers intend. Cognitive debriefing interviews involve incorporating follow-up questions in a field test interview to gain a better understanding of how patients interpret questions asked of them.
Contract Research Organization (CRO)	An organization that offers clinical trial sponsors a wide range of pharmaceutical research services, including product development and formulation, clinical trial management (preclinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA).
Conceptual Framework	The expected relationships of items within a domain and of domains within a PRO concept. The validation process confirms the conceptual framework. When used in a clinical trial, the observed relationships among items and domains will again confirm the conceptual framework.
eClinical Tools	Any electronic device or software that is used by the sponsor of a clinical trial for the purpose of collecting, analyzing, and/or submitting data in support of a new drug application.
Electronic Data Capture	An Electronic Data Capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.
Electronic Patient Diary (eDiary)	An electronic device (i.e., Personal Digital Assistant or PDA) that registers and stores patient diary data and allows for monitoring treatment compliance, symptom and/or Quality of Life data, as entered by patients.
Electronic Patient Reported Outcome (ePRO)	The capture of Patient Reported Outcome data through electronic means (i.e., Personal Digital Assistant (PDA), Interactive Voice Response System (IVRS), Internet, etc.).
Endpoint Model Development	A process whereby clinical trial or treatment efficacy outcomes are conceptualized, tested, and confirmed as quantifiable concepts for use in supporting labeling and promotional claims.
European Medicines Agency (EMA)	EMA is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.
ePRO Instrument Validation	The process of demonstrating retained measurement properties of PRO assessments when migrating from one mode of administration to another (e.g., paper to electronic).
ePRO Solution	An electronic Patient Reported Outcome (ePRO) system that combines an electronic patient diary that study subjects use to record symptom and quality of life data, and an internet-based reporting system that allows clinical trial investigators and sponsors to monitor patient-supplied data throughout a clinical trial.
FDA PRO Guidance	In December 2009 The FDA issued a Guidance on Patient Reported Outcome (PRO) measures, capturing the FDA’s current thinking on PRO data capture in clinical research. It is intended to help sponsors understand what the agency will look for when reviewing NDAs that include the collection of PRO data, including suggestions on how sponsors can best support claims in product labeling with study results measured by PRO instruments.
Food and Drug Administration (FDA)	The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of theUnited Statesfederal executive departments. The FDA is 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 (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
PRO Instrument	The questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual).
Labeling Claim	A claim about the effectiveness or safety of a drug which is stated in its official label, as approved by the Food and Drug Administration (FDA).
New Drug Application (NDA)	When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet FDA’s requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in theUnited States. For internal tracking purposes, all NDA’s are assigned an NDA number.
Observer Reported Outcome (ObsRO)	A report about a patient’s health condition or treatment which is collected by an observer – such as parents observing and rating children – and recording the results.
Patient Diary	A tool used during a clinical trial or a disease treatment to measure treatment compliance and the patient’s observation of symptoms and quality of life.
Patient Reported Outcome (PRO)	Any report coming directly from patients (i.e., study subjects) about a health condition and its treatment.
PRO Assessment	Used interchangeably with PRO Instrument, to describe a study subjects’ observation of symptoms and other treatment affects during the course of a clinical trial.
PRO Instrument Migration	The act of migrating a paper-and-pencil self-administered PRO instrument to administration via a computer or other electronic device (e.g. computer adaptive testing, interactive voice response systems, Web-based questionnaire administration, or Personal Digital Assistant (PDA).
Protocol Compliance	A term that is used to indicate a study subjects’ correct following of a clinical trial protocol, including taking medication at specified times/dosages, avoiding prohibited drugs and substances, and recording symptoms and other quality of life data in a patient diary.
PRO Validation	The process of assessing a PRO instrument’s ability to measure a specific concept or collection of concepts, concluding with the production of a set of measurement properties that are specific to the population form, and format of the PRO instrument tested.
Site-based ePRO	The electronic collection of Patient Reported Outcome (PRO) data by either patients or investigative site personnel at regularly scheduled site visits during a clinical trial.