Patient Reported Outcomes & ePRO Glossary
Patient Reported Outcomes & ePRO Glossary
Glossary of Patient Reported Outcomes (PRO) Terms
| Keyword |
Definition |
| Adaptive Clinical Trial: |
Atrial 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 thetime 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 Research Coordinator (CRC): | An employee of a medical facility certified as an investigative site, whois 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 consentprocess and ensuring compliance with the protocol. |
| Cognitive Interview (aka Cognitive Debriefing) : | A qualitative research tool used to determine whether concepts and itemsare understood by patients in the same way that instrument developersintend. 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 ofpharmaceutical research services, including product development andformulation, 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 clinicaltrial for the purpose of collecting, analyzing, and/or submitting datain 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): |
Anelectronic 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 ResponseSystem (IVRS), Internet, etc.). |
| Endpoint Model Development: |
A process whereby clinical trial or treatment efficacy outcomes areconceptualized, tested, and confirmed as quantifiable concepts for usein supporting labeling and promotional claims. |
| 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 Draft PRO Guidance: |
In February, 2006 The FDA issued a Draft Guidance on Patient Reported Outcomes (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 thatinclude the collection of PRO data, including suggestions on howsponsors can best support claims in product labeling with study results measured by PRO instruments. |
| 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 drugapplication (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 the United States. For internal tracking purposes, all NDA's are assigned an NDA number. |
| 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. |