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clinical characterization case record form (clinical CRF)
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00:56 May 4, 2020
English to Dutch translations [PRO] COVID-19 - Medical - Medical (general) Additional field(s): Medical: Health Care, Science (general)
English term or phrase:clinical characterization case record form (clinical CRF)
Definition from Healthcare Purchasing News: The clinical characterization case record form (clinical CRF) is intended to provide member states with a standardized approach to collect clinical data in order to better understand the natural history of disease and describe clinical phenotypes and treatment interventions (i.e. clinical characterization). By using one standardized clinical data tool, there is potential for clinical data from around the world to be aggregated; in order to learn more to inform the public health response and prepare for large scale clinical trials.
Global COVID-19 clinical characterization Case Record form : a standard approach to collect clinical data of hospitalized patients is necessary to better understand the natural history of disease and describe clinical phenotypes and treatment interventions. Share anonymized clinical data and information related to patients with suspected or confirmed infections on a new clinical data platform. World Health Organization
The rapid clinical characterization case record form (clinical CRF) is intended to provide member states with a standardized approach to collect clinical data in order to better understand the natural history of disease and describe clinical phenotypes and treatment interventions. International Federation on Ageing
Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. National Center for Biotechnology Info.
Case record form: Use “Case report form”. 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 participant. (N2) ase report form (CRF) (paper): Case report form in which the data items are linked by the physical properties of paper to particular pages. See related “Case report form”,“eCRF”. (CDISC) Case report form (CRF) data: Subset of clinical trial data that are entered into fields on a CRF. (CDISC) Electronic case report form (eCRF): 1. Auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial participant. 2. A CRF in which related data items and their associated comments, notes, and signatures are linked electronically. NOTE: eCRFs may include special display elements, electronic edit checks, and other special properties or functions and are used for both capture and display of the linked data. (CDISC)
A case report form (or CRF) is a paper or electronic questionnaire 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 patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
Originally all case report forms were made on paper. But recently there is a changing trend to perform clinical studies using an electronic case report form (eCRF). This way of working has many advantages: Faster and more efficient High security Environmentally friendly
'case report form' wordt normaliter onvertaald gelaten, bijv.:
RICHTSNOER VOOR GOOD CLINICAL PRACTICE
1.11 Case Report Form (CRF) Een gedrukt, optisch of elektronisch document dat ontworpen is om alle volgens het protocol vereiste informatie die per proefpersoon aan de sponsor moet worden gerapporteerd in vast te leggen.
Stap H: Datacollectie Tijdens een onderzoek worden door de onderzoekers vele gegevens betreffende de patiënt/proefpersoon, de ziekte, de behandeling en de uitkomst verzameld. Een selectie van deze data wordt in een database opgeslagen, en daar verwerkt om de uitkomsten van het onderzoek in kaart te brengen. In veel gevallen wordt daartoe een Case Report Form (CRF) gemaakt, waarin deze gegevens systematisch worden bijeengebracht. Uiteindelijk worden de data uit de CRFs in de database ingevoerd. Steeds vaker overigens worden rechtstreeks data vanuit bijvoorbeeld het electronisch patiëntendossier direct in een database ingevoerd, zonder eerst in een CRF te zijn vastgelegd. Of er nu wel of niet een CRF is, de brondata en documenten moeten geborgd zijn.
In Inspectie Gezondheidszorg en Jeugd Afkortingen en begrippen CRF = Case report form: een gedrukt, optisch of elektronisch document dat ontworpen is om alle volgens het protocol vereiste informatie die per proefpersoon aan de verrichter moet worden gerapporteerd in vast te leggen.
Er zijn in totaal maar 41 G-hits voor: 'clinical characterization case record form' vrijwel allemaal gerelateerd aan COVID-19 en waarschijnlijk ook nog dubbele hits.
Hier kun je zien hoe zo'n formulier eruitziet en wat er zoal moet worden ingevuld:
DESIGN OF THIS CASE RECORD FORM (CRF) This CRF has 3 modules: Module 1 to be completed on the first day of admission to the health centre. Module 2 to be completed on first day of admission to ICU or high dependency unit. Module 2 should also be completed daily for as many days as resources allow. Continue to follow-up patients who transfer between wards. Module 3 to be completed at discharge or death.
Novel Coronavirus (COVID-19) Case Report Form
All information on how to start collecting data via the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Case Report From (CRF), as well as a pdf template, can be found on the ISARIC website. On this website you will find not only the COVID-19 CRF, but also the COVID-19 Clinical Characterisation Protocol (see Figure 1 below)
What is the role of COMBACTE/PREPARE in the collection of clinical data of patients with novel coronavirus (COVID-19)?
The COMBACTE and PREPARE clinical networks are supporting ISARIC, based at the University of Oxford and hosting the Novel Coronavirus (NCoV) Data Platform (NCoVDP), in their goal to collect clinical data in a rapid and coordinated fashion. COMBACTE and PREPARE are committed to informing their network members on the need for, and possibility of, standardized data collection during the course of an emerging infection, through using the thoroughly validated and WHO recommended ISARIC COVID-19 case report form (CRF). The CRF is not a study in itself, but a tool to facilitate the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with novel coronavirus (COVID-19). This data can be used for individual sites, or upon agreement, by sites to take part in combined analysis to facilitate disease characterisation and inform clinical management and control. For any detailed questions on the CRF tool, please contact the ISARIC Global Support Centre.
Can I only participate in data collection via the CRF if I also participate in the ISARIC COVID-19 Clinical Characterization Protocol (CCP)?
No, the ISARIC COVID-19 CRF can be used separately. The CRF is an international tool to facilitate the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with novel coronavirus (COVID-19). The COVID-19 Clinical Characterisation Protocol (CCP) is developed as a tiered protocol with the option to also include research sampling. This will require IRB approval of the study protocol. The COVID-19 CRF is aligned with the CCP CRF. The CCP is designed to be used for any emerging and novel pathogen of public health interest, including COVID-19. - combacte
WHO COVID-19 technical guidance: Early investigations protocols
The recent emergence of COVID-19 means that understanding of transmission patterns, severity, clinical features and risk factors for infection remains limited, whether among the general population, for health workers or in household and other “closed” settings, according to a statement from the World Health Organization (WHO).
Studies to assess the epidemiology and clinical characteristics of cases in different settings are therefore critical to furthering our understanding of this virus and associated disease. They will also provide the robust information needed to refine the parameters to feed in forecasting models.
6 - Global COVID-19 Clinical Characterization Case Record Form and new data platform for anonymized COVID-19 clinical data
The clinical characterization case record form (clinical CRF) is intended to provide member states with a standardized approach to collect clinical data in order to better understand the natural history of disease and describe clinical phenotypes and treatment interventions (i.e. clinical characterization). By using one standardized clinical data tool, there is potential for clinical data from around the world to be aggregated; in order to learn more to inform the public health response and prepare for large scale clinical trials. - Healthcare purchasing news
Internationale patientenregistratie waarin gegevens worden verzameld van volwassen patienten met COVID-19 die opgenomen zijn (geweest) in een ziekenhuis. Als basis voor de registratie wordt gebruik gemaakt van de case report form (CRF) opgesteld door ISARIC-WHO. Deze CRF is uitgebreid met addtionele elementen ten aanzien van cardiovasculaire risicofactoren, cardiovasculaire voorgeschiedenis en medicatie, aanvullend cardiaal onderzoek zoals ECG en echocardiografie en cardiale complicaties. - RIVM
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