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reference] and on many standards from metrology. Interoperability between disparate clinical information systems requires common data standards or mapping of every
Clinical_data_standards
Standards developing organization
The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with
Clinical Data Interchange Standards Consortium
Clinical_Data_Interchange_Standards_Consortium
Computational approaches to health care
exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC)
Health_informatics
integrity of the data is of primary importance. Case report form Clinical Data Interchange Standards Consortium (CDISC) Clinical data management system
Clinical_data_acquisition
Process for collecting and managing clinical trial data
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound
Clinical_data_management
Implementation Guide, Controlled Terminology, and more FDA Data Standards - for the FDA's list of supported standards and associated resources SEND Implementation Forum
Standard for Exchange of Non-clinical Data
Standard_for_Exchange_of_Non-clinical_Data
Medical association
national standards. The college has also collaborated with specialty societies to undertake the task of developing and publishing clinical data standards. Clinical
American College of Cardiology
American_College_of_Cardiology
Failure of the heart to provide sufficient blood flow throughout the body
Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Heart Failure)". Circulation: Cardiovascular
Heart_failure
Standard for experimental data tabulation
Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification
SDTM
XML standard for clinical documents
Specification Release 2 Version 3.5". "ISO/HL7 27932:2009 - Data Exchange Standards -- HL7 Clinical Document Architecture, Release 2". "PCEHR Medicare Overview
Clinical Document Architecture
Clinical_Document_Architecture
require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring of a clinical trial is
Monitoring_in_clinical_trials
Data management system used in clinical research
A clinical data management system (CDMS) is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at
Clinical data management system
Clinical_data_management_system
International quality standard for drug testing and production
on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping
Good_clinical_practice
System for medical classification
standards development organization, located in London, UK. SNOMED International is the trading name of the International Health Terminology Standards
SNOMED_CT
Data warehouse standard
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration
JANUS clinical trial data repository
JANUS_clinical_trial_data_repository
Phase of clinical research in medicine
known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after
Clinical_trial
Measure of variation in statistics
useful property of the standard deviation is that, unlike the variance, it is expressed in the same unit as the data. Standard deviation can also be used
Standard_deviation
XML standard for clinical documents
Consolidated Clinical Document Architecture (C-CDA) is an XML-based markup standard which provides a library of CDA formatted documents. Clinical documents
Consolidated Clinical Document Architecture
Consolidated_Clinical_Document_Architecture
Medical care quality improvement process
definitions. Standards-based audit – A cycle which involves defining standards, collecting data to measure current practice against those standards, and implementing
Clinical_audit
Unit of information
data Data (computer science) Data acquisition Data analysis Data bank Data cable Data center Data curation Data domain Data element Data farming Data
Data
Classification of elements of nursing practices
Minimum Data Set (NMDS). (ANA, 2008). Nursing Informatics: Scope and Standards of Practice. Sliver Spring, MD:ANA (Saba, 2011). Overview of the Clinical Care
Clinical Care Classification System
Clinical_Care_Classification_System
Data sharing standards
OSI model. The standards are produced by HL7 International, an international standards organization, and are adopted by other standards-issuing bodies
HL7
Health information technology
decision-making in clinical workflows. CDSS tools include alerts and reminders, clinical guidelines, condition-specific order sets, patient data summaries, diagnostic
Clinical decision support system
Clinical_decision_support_system
State of qualitative or quantitative pieces of information
form agreed upon definitions and standards, including international standards, for data quality. In such cases, data cleansing, including standardization
Data_quality
Care records describe specific clinical data contained within a clinical domain. There have also been XDS standards XDS-I and XDS-b developed for electronic
Cross Enterprise Document Sharing
Cross_Enterprise_Document_Sharing
World Health Organization trials registry
Organization. The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search
International Clinical Trials Registry Platform
International_Clinical_Trials_Registry_Platform
Document in clinical trial research
specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating
Case_report_form
validate AI applications in clinical settings. Standardization of Reporting: Implementing comprehensive reporting standards as proposed by initiatives
Imaging_informatics
Clinical data collection system
data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical
Electronic_data_capture
an acronym for Prostate Imaging Reporting and Data System, defining standards of high-quality clinical service for multi-parametric magnetic resonance
PI-RADS
Internationally agreed format for drug approvals
requirements. Clinical Data Interchange Standards Consortium Clinical trial eCTD Harmonization in clinical trials Junod, Valerie (2005). Clinical drug trials
Common_Technical_Document
US government registry of clinical trials
article. Academic clinical trials Bioethics CIOMS Guidelines Clinical data acquisition Clinical Data Interchange Standards Consortium Clinical trials registry
ClinicalTrials.gov
Reporting standards for clinical trials
White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT
Consolidated Standards of Reporting Trials
Consolidated_Standards_of_Reporting_Trials
development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad. European Clinical Research Infrastructures
European Forum for Good Clinical Practice
European_Forum_for_Good_Clinical_Practice
United States federal regulatory standards
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing
Clinical Laboratory Improvement Amendments
Clinical_Laboratory_Improvement_Amendments
Non-disclosure of information
Waladkhani. (2008). Conducting clinical trials. A theoretical and practical guide. ISBN 978-3-940934-00-0 "Professional Standards Authority – Home". nhs.uk
Confidentiality
Standards for Reporting Enzymology Data (STRENDA) is an initiative as part of the Minimum Information Standards which specifically focuses on the development
Standards for Reporting Enzymology Data
Standards_for_Reporting_Enzymology_Data
Open standard from the medical computer science
published standard, which was developed by the DICOM Standards Committee (which includes some NEMA members). It is also known as NEMA standard PS3 and as
DICOM
Plan for research in clinical medicine
Clinical study design is the formulation of clinical trials and other experiments, as well as observational studies, in medical research involving human
Clinical_study_design
Branch of medicine devoted to mental disorders
Clinical psychology is an integration of human science, behavioral science, theory, and clinical knowledge aimed at understanding, preventing, and relieving
Clinical_psychology
(GLP) a lab quality standard
reliable, and traceable safety data. GLP was first introduced in New Zealand and Denmark in 1972, but only as quality standards for re-agents and lab materials
Good_laboratory_practice
Capability that enables an organization to ensure high data quality
discipline has grown with the rise of big data, cloud computing, and artificial intelligence, where consistent standards and stewardship are essential for privacy
Data_governance
Standard for exchanging electronic health records
exchanging electronic health records (EHR). FHIR builds on previous data format standards from HL7, like HL7 version 2.x and HL7 version 3.x. But it is easier
Fast Healthcare Interoperability Resources
Fast_Healthcare_Interoperability_Resources
Software infrastructure for improving research and storing data
the adoption of XML standards and Internet purchasing. As of 2012, some LIMS have added additional characteristics such as clinical functionality, electronic
Laboratory information management system
Laboratory_information_management_system
American emergency physician (1969–2014)
Force on Clinical Data Standards (Writing Committee to Develop Acute Coronary Syndromes and Coronary Artery Disease Clinical Data Standards)". Circulation
Francis_M._Fesmire
the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice
Trial_master_file
Document format for reporting studies in the scientific literature
mention of reporting standards, and a 2018 study found that even when journals' instructions for authors mention reporting standards, there is a difference
IMRAD
Gathering information for analysis
of individual user data collected through cloud computing, as this data is transferred across countries that have different standards for protecting individual
Data_collection
Health worker who classifies diagnoses
main duties are to analyse clinical statements and assign standardized codes using a classification system. The health data produced are an integral part
Clinical_coder
Medical research using human test subjects
Events Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) Standard for Exchange of Non-clinical Data (SEND) JANUS clinical trial
Outline_of_clinical_research
Form of scientific experiment
an alternative treatment, a placebo, or standard care. RCTs are a fundamental methodology in modern clinical trials and have been widely considered one
Randomized_controlled_trial
Type of statistics
subgroups (e.g., for each treatment or exposure group), and demographic or clinical characteristics such as the average age, the proportion of subjects of
Descriptive_statistics
Organization involved in healthcare informatics interoperability standards
International Inc. is a standards organization that develops technical standards for health data exchange. The HL7 series of standards are its most well known
HL7_International
key summary data from birth to last data entry. OPCRD extracts from all major UK electronic health record (EHR) systems and all clinical coding schemes
Optimum Patient Care Research Database
Optimum_Patient_Care_Research_Database
How many standard deviations apart from the mean an observed datum is
statistics, the standard score or z-score is the number of standard deviations by which the value of a raw score (i.e., an observed value or data point) is
Standard_score
Statistical concept
consequence of linking clinical, genomic and imaging data. The presence of structured missingness may be a hindrance to make effective use of data at scale, including
Missing_data
Clinical data collection method
validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data. The two main methods currently
Electronic patient-reported outcome
Electronic_patient-reported_outcome
U.S. examination program for medical licensure
questions and responses. Integrated Clinical Encounter (ICE) – includes assessments of both data gathering and data interpretation skills. Scoring for
United States Medical Licensing Examination
United_States_Medical_Licensing_Examination
self-contained. Incremental updates: with its sequence number. Clinical trial Clinical Data Interchange Standards Consortium European Medicines Agency (EMA) Food and
Electronic common technical document
Electronic_common_technical_document
Practical importance of a treatment
between observed data and what would be expected under the assumption that the null hypothesis is true. In broad usage, the "practical clinical significance"
Clinical_significance
Electronically formatted trial master file
interoperability of eTMF data among clinical trial stakeholders, in September 2013 non-profit CareLex and SureClinical initiated an eTMF standards initiative under
Electronic_trial_master_file
Study of collection and analysis of data
A standard statistical procedure involves the collection of data leading to a test of the relationship between two statistical data sets, or a data set
Statistics
United States federal agency
portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health
Centers for Medicare & Medicaid Services
Centers_for_Medicare_&_Medicaid_Services
Diagnosis, treatment, and prevention of illness
medicine, cellular pathology, clinical chemistry, hematology, clinical microbiology, and clinical immunology. Clinical neurophysiology is concerned with
Medicine
Process of converting plaintext to ciphertext
provides a safe harbor for encrypted data: breaches involving ePHI that has been encrypted in accordance with NIST standards are not considered reportable breaches
Encryption
Information management applied to health and health care
care delivery. They work with clinical, epidemiological, demographic, financial, reference, and coded healthcare data. Health information administrators
Health_information_management
Standard for patient medical document exchange
specification is an XML-based markup standard intended to specify the encoding, structure, and semantics of a patient summary clinical document for exchange. The
Continuity_of_Care_Document
Relative measure of dispersion expressed as the ratio of standard deviation to the mean
Sawant, S.; Mohan, N. (2011) "FAQ: Issues with Efficacy Analysis of Clinical Trial Data Using SAS" Archived 24 August 2011 at the Wayback Machine, PharmaSUG2011
Coefficient_of_variation
Quality Assessment (QA), under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. It is designed to enable regulated
Individualized Quality Control Plan
Individualized_Quality_Control_Plan
Collection of data
healthcare relies on data sets for clinical research and improving patient outcomes. These varied applications demonstrate the critical role data sets play in
Data_set
minimum outcomes to be measured and reported in all clinical trials related to a specific clinical area. It is developed through a rigorous consensus process
Core_outcome_set
Design of tasks
Experimental design in statistical mathematics Clinical study design – Plan for research in clinical medicine Computer experiment – Experiment used to
Design_of_experiments
Browser-based data capture software for academic research
(Research Electronic Data Capture) is a browser-based, metadata-driven EDC software and workflow methodology for designing clinical and translational research
REDCap
to lowered ratings in the NIJ standard. The old (pre-2017) standards are as follows: With the 2017 revision, the standards have changed significantly. Threat
List of body armor performance standards
List_of_body_armor_performance_standards
Scientific practice
test intervention when in fact the accumulated data do not show this, if all data were made public. ClinicalTrials.gov was originally developed largely as
Preregistration_(science)
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a
Clinical_research_coordinator
Study of health and disease within a population
systematic review). Epidemiology has helped develop methodology used in clinical research, public health studies, and, to a lesser extent, basic research
Epidemiology
Concept in medicine referring to design of clinical trials
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis
Adaptive_design_(medicine)
Condition in which the value of a measurement or observation is only partially known
problem of censored data, in which the observed value of some variable is partially known, is related to the problem of missing data, where the observed
Censoring_(statistics)
established standards to support the acquisition, exchange, submission and archiving of clinical research data and metadata. CDISC standards are vendor-neutral
Data_definition_specification
The Linked Data Modeling Language, or LinkML, is a data modeling framework based on YAML that aims to "bring semantic web standards to the masses, simplifying
LinkML
Data combined from several measurements
aggregated healthcare data allows health care providers to unbolt actionable clinical insights when for instance, thorough views of clinical data or continuous
Aggregate_data
India's clinical trial registry
July 2007. Since 2009 the Central Drugs Standard Control Organisation has mandated that anyone conducting clinical trials in India must preregister before
Clinical Trials Registry – India
Clinical_Trials_Registry_–_India
medical and healthcare data in areas including disease diagnosis, treatment planning,, patient monitoring, drug development, and clinical decision support systems
Artificial intelligence in healthcare
Artificial_intelligence_in_healthcare
Algorithmically generated data that have a similar distribution as sampled data
authentic data and it may not recognize another type of intrusion. Researchers doing clinical trials or any other research may generate synthetic data to aid
Synthetic_data
Modern type of examination in medicine, pharmacy and similar disciplines
An objective structured clinical examination (OSCE) is a practical examination format used to assess clinical competence, especially in medicine, pharmacy
Objective structured clinical examination
Objective_structured_clinical_examination
Self-identification collected by the US census
revisions to the standards for the classification of federal data on race and ethnicity. The OMB developed race and ethnic standards in order to provide
Race and ethnicity in the United States census
Race_and_ethnicity_in_the_United_States_census
Measure of statistical dispersion
(IQR) is a measure of statistical dispersion, which is the spread of the data. The IQR may also be called the midspread, middle 50%, fourth spread, or
Interquartile_range
Data about other data
important aspect of each organizations data exchange standards. Within the United States, Naming and Design Rules standards are recommended for each federal
Metadata
Statistical property
experimental data are often summarized either using the mean and standard deviation of the sample data or the mean with the standard error. This often
Standard_error
Database and universal standard
and clinical LOINC. Clinical LOINC contains a subdomain of Document Ontology which captures types of clinical reports and documents. Several standards, such
LOINC
Study with uncontrolled variable of interest
provide part of the community-level data needed to design more informative pragmatic clinical trials; and inform clinical practice." In all of those cases
Observational_study
Creating a model of the data in a system
National Institute of Standards and Technology (NIST). December 21, 1993. Amnon Shabo (2006). Clinical genomics data standards for pharmacogenetics and
Data_modeling
Combination of two antibiotic drugs
Lewis's Medical-Surgical Nursing EBook: Assessment and Management of Clinical Problems. Elsevier Health Sciences. p. 1173. ISBN 978-0-7295-8708-2. Archived
Trimethoprim/sulfamethoxazole
Pharmacology database
(with GtoPdb being the standard abbreviation) is developed as a joint venture between the International Union of Basic and Clinical Pharmacology (IUPHAR)
Guide_to_Pharmacology
Digital collection of patient and population electronically stored health information
paramedics, review of clinical standards, better research options for pre-hospital care and design of future treatment options, data-based outcome improvement
Electronic_health_record
(investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). (ICH E6) Adverse reaction
Glossary_of_clinical_research
Set of detailed instructions to assist in workplace safety
by one or more SOPs, depending on how many alternatives may apply. In clinical research, the International Council for Harmonisation (ICH) defines SOPs
Standard_operating_procedure
Statistical measure of variability
statistic, being more resilient to outliers in a data set than the standard deviation. In the standard deviation, the distances from the mean are squared
Median_absolute_deviation
Title XIII of the American Recovery and Reinvestment Act of 2009
The Health Information Technology for Economic and Clinical Health Act, abbreviated the HITECH Act, was enacted under Title XIII of the American Recovery
Health Information Technology for Economic and Clinical Health Act
Health_Information_Technology_for_Economic_and_Clinical_Health_Act
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
Female
Hebrew
(דִּיתָה) Pet form of Hebrew Yehuwdiyth, DITA means "Jewess" or "praised." Compare with another form of Dita.
Female
Hindi/Indian
(लता) Hindi name derived from a plant name, from the Sanskrit word lata, LATA means "creeper," in reference to a creeping plant.
Male
English
English surname transferred to unisex forename use, possibly DANA means "from Denmark."
Female
English
 English surname transferred to unisex forename use, possibly DANA means "from Denmark." Compare with other forms of Dana.
Male
Hebrew
(דֶּרַע) Hebrew name DARA means "the arm." In the bible, this is the name of a son of Zerah. Compare with other forms of Dara.
Female
Polish
Short form of Polish Edyta, DYTA means "rich battle."
Male
Irish
 From Irish Gaelic Mac Dara, DARA means "son of oak." Compare with other forms of Dara.
Female
English
 Middle English name DARA means "brave, daring." Compare with another form of Dara.
Male
Turkish
Turkish name ATA means "ancestor."
Female
Hebrew
(×“Ö¼Ö¸× Ö¸×”) Feminine form of Hebrew Dan, DANA means "judge." Compare with other forms of Dana.
Male
Irish
Irish Gaelic name MAC DARA means "son of oak." This is the name of a patron saint and is still common in Ireland, especially in Connemara.
Female
Slavic
 Short form of Slavic Bogdana, DANA means "gift from God." Compare with other forms of Dana.
Female
Russian
 Short form of Russian Yekaterina, KATA means "pure." Compare with other forms of Kata.
Female
Polish
 Variant spelling of Polish Dyta, DITA means "rich battle." Compare with another form of Dita.
Female
Hungarian
 Short form of Hungarian Katalin, KATA means "pure." Compare with other forms of Kata.
Male
Iranian/Persian
 Short form of Persian Dârayavahush, DARA means "possesses a lot, wealthy." Compare with other forms of Dara.
Male
Hebrew
Variant spelling of Hebrew Dathan, DATAN means "belonging to a fountain."
Female
Finnish
Variant form of Finnish Aada, AATA means "noble."
Boy/Male
Latin
Critical.
Female
Finnish
 Short form of Finnish Katariina, KATA means "pure." Compare with other forms of Kata.
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS
CLINICAL DATA-STANDARDS