Data are facts, numbers, or any type of quantitative or qualitative information that is obtained from individuals participating in a clinical study (e.g., age, gender, education, etc.).
In clinical research, data acquisition is accessing, recording or collecting information that researchers can use for analysis and interpretation (e.g., surveys, direct observation, reviewing medical records, etc.).
The Data and Safety Monitoring Board (DSMB) is a group of experts who oversee and monitor clinical studies to ensure participant safety and the validity and integrity of the data. The DSMB is independent of the organizations, institutions, and individuals conducting the clinical study. They can recommend that a study be changed or stopped early because of concerns about participant safety or because the main research question has been answered.
The data and safety monitoring plan is included with the grant application for clinical studies. It establishes: the overall framework for data and safety monitoring, how adverse events will be reported to the Institutional Review Board and the National Institutes of Health (NIH), when the study should be continued or stopped, and (when appropriate) how the NIH guidelines and Food and Drug Administration regulations for investigational medicines and investigational devices will be satisfied.
In clinical research, data capture is accessing, recording or collecting information that researchers can use for analysis and interpretation (e.g., surveys, direct observation, reviewing medical records, etc.).
In clinical research, data collection is accessing, recording or collecting information that researchers can use for analysis and interpretation (e.g., surveys, direct observation, reviewing medical records, etc.).
The data collection instrument is a paper or electronic document used to record, transcribe, or collect clinical data, such as a survey questionnaire.
Data entry is the process of physically entering information either on paper or electronically (e.g., data form, computer, tablet, voice recorder, etc.)
Data integrity is the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time and throughout the time the data are needed.
Data management refers to any and all processes involved with collecting, handling, storing, processing, transmitting, analyzing, or otherwise dealing with data associated with a clinical study.
The data management plan documents the processes associated with collecting, handling, storing, processing, transmitting, analyzing, or otherwise dealing with data in a clinical study.
The data monitoring committee is a group of individuals (independent of the study investigators) that assess clinical study progress and monitor participant safety, treatment efficacy, and data quality at specific time intervals during the study.
Data quality pertains to data accuracy, sensitivity, validity, and suitability. Researchers and results evaluators may reasonably trust data that are accurate, have been reviewed by investigators, and have been protected from unauthorized alteration.
Data selection criteria are the rules by which particular information is selected and/or transferred between: where a participant received treatment to the participant's record, from the participant's record to the clinical study's database; and from the clinical study's database to those who will analyze the information collected in the clinical study.
Data validation is the process that determines whether the information collected that is to be included and/or used in a clinical study is accurate, authentic, and complete.
Date of first enrollment is the date and time that the first participant enrolled in a clinical study.
Demographic data refers to the various characteristics of the participants in a clinical study. It include information such as: sex, age, family history related to the disease/condition being studied, and other characteristics that may be relevant to the clinical study in which they are participating.
Diagnosis is the process where a clinician identifies the disease or condition that explains the symptoms and signs a participant is experiencing.
Diagnostic trials evaluate methods, tests, or procedures for diagnosing or treating a particular disease or condition.
Discontinuation is when a participant leaves a clinical study before all protocol-required elements are completed.
Disease refers to the disorder, syndrome, illness, injury, or condition that is being studied. Disease may also include other health-related issues, such as lifespan, quality of life, and health risks.
The National Cancer Institute created the Division of Cancer Control and Population Studies in order to generate new knowledge and ensure that cancer research is effectively applied in all segments of the population.
The National Cancer Institute created the Division of Cancer Prevention to lead, support, and promote rigorous, innovative research and training to prevent cancer and its consequences to improve the health of all people.
Dose is the amount of a medicine administered at a single point in time. It is usually expressed as a weight, volume, or a number of items administered.
Dose strength is the relative amount/strength of each active ingredient in a single dose of a medicine or radiation treatment.
Dose discontinuation is the point/time when a clinical study participant permanently stops taking the study medication for any reason. This may be at the end of the study or before the end of the study, if the participant wants to stop taking the medicine for any reason.
In double-blinded studies, neither the participants nor the investigators are aware of which participants received which treatments. The purpose of blinding is to reduce bias.
In double-masked studies, neither the participants nor the investigators are aware of which participants received which treatments. The purpose of blinding is to reduce bias.
Dropout is when a participant leaves a clinical study before all the protocol-required elements are completed.
