term
stringlengths 2
142
⌀ | definition
stringlengths 9
116k
⌀ | sources
listlengths 1
1
⌀ | source
stringclasses 48
values | type
stringclasses 5
values | file
stringclasses 26
values | sheet
stringclasses 3
values | text
stringclasses 212
values |
|---|---|---|---|---|---|---|---|
radiopharmaceutical medicinal product
|
<b>CDISC Definition:</b> Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. [DIRECTIVE 2001/83/EC Article 1.(11)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
random allocation
|
<b>CDISC Definition:</b> Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: in a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
random number table
|
<b>CDISC Definition:</b> Table of numbers with no apparent pattern used in the selection of random samples for clinical trials.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
random sample
|
<b>CDISC Definition:</b> Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
randomization
|
<b>CDISC Definition:</b> The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Randomization can be executed according to imposed rules to achieve desired distribution. For example, unequal randomization is used to allocate subjects into groups at a differential rate, e.g., three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
randomized controlled trial (RCT)
|
<b>CDISC Definition:</b> A well-controlled clinical trial in which subjects are assigned to treatment or control groups according to randomization principles. See randomization. [After FDA and Clinical Drug Trials : A Short History, S.White Junod, 2008; CONSORT statement] See also randomization, clinical trial, controlled study, adequate and well-controlled studies.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
raw data
|
<b>CDISC Definition:</b> Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations. Researcher's records of subjects/patients, such as patient medical charts, hospital records, X-rays, and attending physician's notes. NOTE: These records may or may not accompany an application to a Regulatory authority, but must be kept in the researcher's file. See also eSource, source data, source documents.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
RCRIM
|
<b>CDISC Definition:</b> Regulated Clinical Research and information Management, which is a Technical Committee within HL7 (an acronym pronounced "arcrim").
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Real-World Data (RWD)
|
<b>CDISC Definition:</b> Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Evidence (RWE)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Real-World Evidence (RWE)
|
<b>CDISC Definition:</b> The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Data (RWD).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
rechallenge
|
<b>CDISC Definition:</b> To reintroduce a previously withdrawn or temporarily discontinued medical intervention to the same participant. NOTE: Rechallenge requirements may be described in the protocol. [After ICH M11]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
reconstruction (of a study)
|
<b>CDISC Definition:</b> For eClinical trials FDA expects archival trial records to support review of the data as well as the processes used for obtaining and managing the data so that the trustworthiness of results obtained can be evaluated. NOTE: Reconstruction from records should support evaluation of the operation and validity of computerized systems and the conformance of the systems to applicable regulations during design and execution of the trial as well as during the period of record retention. [from CSUCT VI D, 21 CFR Parts 11, 312]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
record retention
|
<b>CDISC Definition:</b> The act of maintaining or holding records for future use, often under the policies and procedures of a formally established regulatory records retention program, for some specified period of time. [After Rutgers University Institutional Planning and Operations, Records Management Definitions, https://ipo.rutgers.edu/business-services/records-management/definitions, accessed 2025-02-27; After ICH E6; After US FDA 21 CFR Part 11] See also personal data, processing (personal data).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
record
|
<b>CDISC Definition:</b> In a regulated environment, documented information in any format that is subject to the requirements for data integrity, and should be controlled and maintained. NOTE: The requirements for data integrity are covered by the ALCOA plus principles. [After 21 CFR Part 11, Parts 210, 211, and 212; 21 CFR 312.61 and 312.62] See also data integrity, ALCOA plus, electronic record, control of electronic records, EHR (electronic health record), electronic personal health record (ePHR), EMR (electronic medical record), trustworthy (electronic records), source data, source document.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
recruitment (investigators)
|
<b>CDISC Definition:</b> Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
recruitment (subjects)
|
<b>CDISC Definition:</b> Process used by investigators to find and enroll appropriate subjects (those selected on the basis of the protocol's inclusion and exclusion criteria) into a clinical study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
recruitment period
|
<b>CDISC Definition:</b> Time period during which subjects are or are planned to be enrolled in a clinical trial
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
recruitment target
|
<b>CDISC Definition:</b> Number of subjects that must be recruited as candidates for enrollment into a study to meet the requirements of the protocol. in multicenter studies, each investigator has a recruitment target.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Reference information Model (RIM)
|
<b>CDISC Definition:</b> An information model used as the ultimate defining reference for all HL7 standards. [HL7]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
reference member state (RMS)
|
<b>CDISC Definition:</b> A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. The first Member State that has authorized the product in the RMS. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem .html] See also Mutual Recognition Procedure (MRP) and Concerned Member State (CMS).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
regenerative medicine advanced therapy (RMAT) designation
|
<b>CDISC Definition:</b> An FDA designation for regenerative medicine therapies to treat, modify, reverse, or cure serious conditions that are eligible for FDA's expedited programs if they meet the criteria for such programs. [After http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine therapy (RMT), regenerative medicine.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
regenerative medicine therapy (RMT)
|
<b>CDISC Definition:</b> A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
regenerative medicine
|
<b>CDISC Definition:</b> A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
registry
|
<b>CDISC Definition:</b> A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions. NOTE: The registry should contain basic information about each trial sufficient to inform interested subjects (and their healthcare practitioners) how to enroll in the trial. [FDAMA 113]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
regulatory application
|
<b>CDISC Definition:</b> Application made to a health authority to investigate, market, or license a new product or indication.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
regulatory authorities
|
<b>CDISC Definition:</b> Bodies having the power to regulate. NOTE: In the ICH GCP guideline the term includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. [ICH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
relative risk
|
<b>CDISC Definition:</b> A measure of the risk of an event happening in one group or situation, compared to the risk of the same event happening in another group or situation. [After NCI Thesaurus; After FDA Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule Sept 2010; After EMA Glossary of Regulatory Terms]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
remote clinical trial
|
<b>CDISC Definition:</b> A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual visits (e.g., via electronic communication). [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also virtual, decentralized clinical trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
repeat rule
|
<b>CDISC Definition:</b> Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
replacement
|
<b>CDISC Definition:</b> The act of enrolling a new study subject to compensate for a subject who is no longer participating.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
report
|
<b>CDISC Definition:</b> A document that presents information in a structured format intended for a specific purpose and recipient. See also final report, interim clinical trial/study report, monitoring report, document (HL7), clinical study (trial) report.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
rescue medications
|
<b>CDISC Definition:</b> Medicinal products identified in the protocol as those that may be administered to subjects when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. [After EU-CTR Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
research hypothesis
|
<b>CDISC Definition:</b> A supposition or proposal based on observations or facts that requires further investigation or exploration to answer a research question. [After Shreffler J, Huecker MR. Hypothesis Testing, P Values, Confidence Intervals, and Significance. [Updated 2023 Mar 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557421/]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
residual risk
|
<b>CDISC Definition:</b> In assessing the risk of re-identifying a trial participant, the risk that remains after controls are taken into account (the net risk or after controls). [Institute of Medicine report, Appendix B]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
response option
|
<b>CDISC Definition:</b> One of several choices to be available for selection in response to a prompt, question or instruction (i.e., a stem) in a PRO item. See also common data element, stem.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
result synopsis
|
<b>CDISC Definition:</b> The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
results posting (results submission)
|
<b>CDISC Definition:</b> The process of submitting and updating summary information about the results of a clinical study to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
results posting date (results submission date)
|
<b>CDISC Definition:</b> The date and time the summary information about the results of the clinical study are submitted to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
retrospective data capture
|
<b>CDISC Definition:</b> Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time. NOTE: Retrospective capture is important in PROs because of "recall bias" and other errors documented in psychological research comparing contemporaneous self-reported assessments and those that rely on recall from memory.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
retrospective study
|
<b>CDISC Definition:</b> A study with planned observations collected predominantly before study start (i.e., backward-looking). NOTE: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [After ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
RHIO (Regional Health Information Organization)
|
<b>CDISC Definition:</b> A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Risk Evaluation and Mitigation Strategy (REMS)
|
<b>CDISC Definition:</b> A drug safety program of the U.S. Food and Drug Administration (FDA), which can be required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. NOTE: REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. [US FDA, Risk Evaluation and Mitigation Strategies (REMS), https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems, Accessed 2025-05-22] See also risk-benefit assessment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
risk
|
<b>CDISC Definition:</b> In clinical trials, the probability of harm or discomfort for subjects. NOTE: Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of troubling side effects. However, the possibility of unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
risk-based monitoring
|
<b>CDISC Definition:</b> Study monitoring that focuses on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. [After FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, 2019] See also monitoring.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
risk-benefit assessment
|
<b>CDISC Definition:</b> A qualitative and analytic evaluation of the potential harm effects and possible positive effects. NOTE: Assessments can be performed in the context of an intervention and/or the individual or population participating in a clinical trial. [After FDA Guidance on Benefit-Risk Assessment for New Drug and Biological Products, October 2023] See also Risk Evaluation and Mitigation Strategy (REMS).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
risk-benefit ratio
|
<b>CDISC Definition:</b> A quantitative assessment of an activity's relative risks and benefits to the individual. NOTE: The term 'risk' refers to the possibility of experiencing a harm. [After NCI Thesaurus; After Coleman CH. Risk-Benefit Analysis. In: Laurie G, Dove E, Ganguli-Mitra A, et al., eds. The Cambridge Handbook of Health Research Regulation. Cambridge Law Handbooks. Cambridge University Press; 2021:130-138.; US FDA Benefit-Risk Assessment for New Drug and Biological Products, Guidance for Industry, October 2023] See also relative risk.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
role (CDISC classifier)
|
<b>CDISC Definition:</b> Classifier for variables that describe "observations" in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable. [SDTM]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
route of administration (ROA)
|
<b>CDISC Definition:</b> The way in which a pharmaceutical product is taken into, or makes contact with, the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
SAFE
|
<b>CDISC Definition:</b> BioPharma(TM) Digital Identity and Signature Standard.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
safety and tolerability
|
<b>CDISC Definition:</b> The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
safety
|
<b>CDISC Definition:</b> Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sample size adjustment
|
<b>CDISC Definition:</b> An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sample size calculation
|
<b>CDISC Definition:</b> A statistical calculation to determine the number of subjects required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. [After ICH E9, 3.5]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sample size
|
<b>CDISC Definition:</b> A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
schedule of activities
|
<b>CDISC Definition:</b> A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
schedule of assessments
|
<b>CDISC Definition:</b> A tabular representation of planned protocol events and activities, in sequence. [after E3 Annexes IIIa and IIIb] Compare to study design schematic.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screen failure
|
<b>CDISC Definition:</b> At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screen/screening (of substances)
|
<b>CDISC Definition:</b> Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests. [SQA]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screening (of sites)
|
<b>CDISC Definition:</b> Determining the suitability of an investigative site and personnel to participate in a clinical trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screening (of subjects)
|
<b>CDISC Definition:</b> A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screening (period)
|
<b>CDISC Definition:</b> A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
screening trials
|
<b>CDISC Definition:</b> A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
script
|
<b>CDISC Definition:</b> A program or a sequence of instructions that are interpreted or carried out by another program or by a person.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
secondary objective
|
<b>CDISC Definition:</b> The supportive or ancillary scientific question(s) the study is designed to answer. [After ICH E8] See also objective, primary objective, exploratory objective.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
secondary outcome variable
|
<b>CDISC Definition:</b> Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
secondary sponsor
|
<b>CDISC Definition:</b> Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. [WHO, CTR item 6]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
self-evident change
|
<b>CDISC Definition:</b> A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF (e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided). See also discrepancy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
semantic interoperability
|
<b>CDISC Definition:</b> The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
semantic
|
<b>CDISC Definition:</b> In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. syntax can change without affecting semantics. [HL7]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
SEND (standard for the exchange of nonclinical data)
|
<b>CDISC Definition:</b> The CDISC standard for the exchange of nonclinical data whose focus is on data collected from animal toxicology studies. [CDISC]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sensitive data
|
<b>CDISC Definition:</b> Any piece of information that can be used to identify or cause harm to an individual person. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. Elements considered sensitive data between US and EU may differ. [After HIPAA; After EU Directive 95/46/EC; After Protection of Personal Data in Clinical Documents - A Model Approach, PHUSE] See also personal data, processing (personal data).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sensitivity (medical test)
|
<b>CDISC Definition:</b> The proportion of positive tests out of all tests for subjects with a condition (true-positive rate). NOTE: Sensitivity represents the likelihood that a subject with the disease or other condition will have a positives test result. [After Diagnostic Testing Accuracy: Sensitivity, Specificity, Jacob Shreffler; Martin R. Huecker, Predictive Values and Likelihood Ratios, StatPearls Publishing, 2024 Jan; After Understanding Medical Tests and Test Results in Merck Manuals, Brian Mandell at Case Western University]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
serious adverse drug reaction
|
<b>CDISC Definition:</b> Adverse drug reaction that at any dose of the drug: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972); 2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
serious adverse event (SAE)
|
<b>CDISC Definition:</b> Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
serious adverse experience (SAE)
|
<b>CDISC Definition:</b> Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
serious breach
|
<b>CDISC Definition:</b> A breach of Clinical Trial Regulation (EU) No 536/2014 or of the version of the protocol applicable at the time of the breach, which is likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial. [Article 52 of Regulation (EU) 536/2014 and Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol] See also privacy breach.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
serious risk
|
<b>CDISC Definition:</b> Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
server
|
<b>CDISC Definition:</b> A computer that controls a central repository of data, files, and/ or applications that can be accessed and/or manipulated in some manner by client computers. NOTE: A file server hosts files for use by client machines. A web server supports browser-based use of central applications.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
severe
|
<b>CDISC Definition:</b> A term for grading intensity on a relative scale describing a symptom, outcome, or event that is of a high level of intensity. Note: The term is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction or a Grade 3 adverse event in oncology). 'Severe' is different from 'serious,' which is based on patient/event outcome or action and serves as a guide for defining regulatory reporting obligations. The distinction is important to maintain when translating the concepts. [After ICH E2A, E2B; After CIOMS Cumulative glossary with a focus on pharmacovigilance. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2023.; After CTCAE] See also serious adverse event and serious adverse drug reaction.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sex
|
<b>CDISC Definition:</b> Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
side effect
|
<b>CDISC Definition:</b> Any action or effect of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction, treatment effect, therapeutic effect.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sign
|
<b>CDISC Definition:</b> An observation by a medical professional obtained from examination, test result, or questionnaire that indicates a patient may have a disease. NOTE: Some examples of signs are fever, swelling, skin rash, high blood pressure, and high blood glucose. [After NCI Glossary] See also diagnosis, symptom.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
signal of a serious risk
|
<b>CDISC Definition:</b> Information related to a serious adverse drug experience associated with use of a drug and derived from-(a) a clinical trial; (b) adverse event reports; (c) a post-approval study; (d) peer-reviewed biomedical literature; (e) data derived from the post-market REMs. [505-1(b) of FD&C Act (21 USC. 355-1(b)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
single-blind study
|
<b>CDISC Definition:</b> A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called single-masked study. See also blind study, double-blind study, triple-blind study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
single-entity product
|
<b>CDISC Definition:</b> A product composed of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity. [After 21 CFR 3.2 (e) FAQ] See also combination product, co-packaged product, cross-labeled product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
site investigator
|
<b>CDISC Definition:</b> A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [ICH E6 1.35. 2.] See also investigator, coordinating investigator, investigator/institution, principal investigator, sponsor-investigator, sub-investigator.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
SNOMED (Systematized Nomenclature of Medicine)
|
<b>CDISC Definition:</b> A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. NOTE: Terms are applied to one of eleven independent systematized modules and presented in a multiaxial and hierarchical structure.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
social circumstances
|
<b>CDISC Definition:</b> A set of concepts that results from or is influenced by criteria or activities associated with the social environment of a person. [NCI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
software as a medical device (SaMD)
|
<b>CDISC Definition:</b> Software intended to be used for the performance of one or more medical purposes, without being part of a hardware medical device. [After "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
software validation
|
<b>CDISC Definition:</b> Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to "ensure user needs and intended uses can be fulfilled on a consistent basis" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, "the evaluation of software at the end of the software development process to ensure compliance with the user requirements" (ANSI/ASQC A3-1978) and should not be thought of as an "end-to-end" verification. See also validation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
software verification
|
<b>CDISC Definition:</b> The process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. NOTE: Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated [After 1. FDA General Principles of Software Validation; 2. ANSI/ASQC A3-1978; 3. ISO/IEC 17025:2017]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
software
|
<b>CDISC Definition:</b> Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
source data verification
|
<b>CDISC Definition:</b> The process of ensuring that data that have been derived from source data accurately represent the source data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
source data
|
<b>CDISC Definition:</b> All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). [ICH E6; CSUCT]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
source document verification (SDV)
|
<b>CDISC Definition:</b> The process by which the information reported by an investigator is compared with the source records or original records to ensure that it is complete, accurate, and valid. [Schuyl and Engel, 1999; Khosla et al., Indian J. Pharm 32:180-186, 2000] See also data validation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
source documents
|
<b>CDISC Definition:</b> Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial). See also eSource document, source, original data, certified copy. [ICH; CSUICI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
source
|
<b>CDISC Definition:</b> The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE: The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of "source." The term is also sometimes used as shorthand for source documents and/or source data. [After ICH E6, CSUICI] See also source document, source data, original data, certified copy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
special populations
|
<b>CDISC Definition:</b> Subsets of study populations of particular interest included in clinical trials to ensure that their specific characteristics are considered in interpretation of data (e.g., geriatric). [FDA]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
special purpose domain
|
<b>CDISC Definition:</b> In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level non-observational domains, which are not classified under the SDTM general observation classes. Examples include trial design domains, relationship domains, etc. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, general observational class.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
specificity (medical test)
|
<b>CDISC Definition:</b> The proportion of negative tests out of all tests for subjects who do not have a disease or condition (true-negative rate). NOTE: Specificity represents the likelihood that a subject without the disease or other condition will have a negative test result. [After Diagnostic Testing Accuracy: Sensitivity, Specificity, Jacob Shreffler; Martin R. Huecker, Predictive Values and Likelihood Ratios, StatPearls Publishing, 2024 Jan; After Understanding Medical Tests and Test Results in Merck Manuals, Brian Mandell at Case Western University]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.