Month: April 2023

Causality assessment

The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event in a specific individual. Causality assessment is usually

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Case report form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.Source:

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Caregiver

A person who helps a patient with daily activities, healthcare, or other activities that the patient is unable to perform because of age, illness or

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Candidate gene study

A study that evaluates the association of specific genetic variants with outcomes or traits of interest, selecting the variants to be tested according to explicit

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Ennov Dossier

Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.

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Ennov Doc

Efficiently manage and share documents with Ennov Doc. Metadata-based document model, efficient search capabilities, intuitive interface.

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Ennov CTMS

Efficiently manage clinical trials with Ennov CTMS. Unified platform, pre-integrated with eTMF and EDC, customizable workflows.

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Ennov EDC

Simplify Clinical Data Collection with Ennov EDC. Configurable edit checks, allowable values library, and pre-integrated with eTMF and CTMS.

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Burden to patients

The additional load that a clinical activity imposes on patients above that which would be experienced under normal clinical practice. Source: (CIOMS XI: Patient involvement

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Ennov eTMF

Effortlessly manage clinical trial documentation with Ennov eTMF. Centralized repository, intelligent automation, and real-time dashboards.

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Ennov Process

Streamline Your Business Processes with Ennov Process BPMS. Automate, ensure compliance and increase efficiency.

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Ennov Training

Streamline Training with a Learning Management System. Simplify compliance monitoring, evaluate staff proficiency, automate onboarding.

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Bonferroni Correction

A correction to allow for the probability of many events that are independent, named after Carlo Emilio Bonferroni (1892-1960). In statistical significance testing, it allows,

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Biomarker

A measured characteristic of either normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic

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Binary Analysis

An analysis involving only two categories (e.g., baseline vs final values, in contrast to analysis of multiple values from continuous measurements, as for a progression

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Bayesian

A theorem in probability named after Reverend Thomas Bayes (1702-1761). It is used to refer to a philosophy of statistics that treats probability statements as

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Baseline characteristics

Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be

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Alert

An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)

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AGREE Instrument

A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)

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Adoption

One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the

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Acceptable Risk

The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what

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Academia

The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)

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Absolute Risk

The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect.

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