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Clinical data management information


Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.[1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics.[citation needed]

  1. ^ Krishnankutty, B; Bellary, S; Kumar, NB; Moodahadu, LS (2012). "Data management in clinical research: An overview". Indian J Pharmacol. 44 (2): 168–72. doi:10.4103/0253-7613.93842. PMC 3326906. PMID 22529469.

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Clinical data management

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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound...

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Clinical data management system

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A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered...

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Clinical trial management system

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used "eClinical" to name technologies such as electronic data capture, clinical trial management systems or Randomization and Trial Supply Management systems...

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Clinical Data Interchange Standards Consortium

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The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with...

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Good clinical data management practice

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Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and...

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Data entry

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verification Quality control Clinical data management Data verification Data entry clerk Input (computer science) "Data entry ... Person based jobs" "Work...

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Electronic data capture

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data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical...

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Prioritization

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that are necessary to preserve the welfare of client or patient. In the clinical context, establishing priorities aids in the rationale and justification...

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Common Technical Document

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requirements. Clinical Data Interchange Standards Consortium Clinical trial eCTD Harmonization in clinical trials Junod, Valerie (2005). Clinical drug trials...

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Medidata Solutions

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(SaaS) for clinical trials. These include protocol development, clinical site collaboration and management; randomization and trial supply management; capturing...

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Clinical data acquisition

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integrity of the data is of primary importance. Case report form Clinical Data Interchange Standards Consortium (CDISC) Clinical data management system (CDMS)...

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Case report form

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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...

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Electronic common technical document

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lifecycle management is composed at least of: Initial submission: should be self-contained. Incremental updates: with its sequence number. Clinical trial...

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Clinical coder

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main duties are to analyse clinical statements and assign standardized codes using a classification system. The health data produced are an integral part...

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Data monitoring committee

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monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Many randomized clinical trials are double-blind – no one involved with...

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Clinical trial

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known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after...

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Source document

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A source document is a document in which data collected for a clinical trial is first recorded. This data is usually later entered in the case report form...

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Title 21 CFR Part 11

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harmonization efforts when applying these guidances to source data generated at clinical study sites. FDA had previously announced that a new Part 11 would...

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Data quality

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normalization Data visualization Data Analysis Data science Clinical data management Redman, Thomas C. (30 December 2013). Data Driven: Profiting from Your...

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Laboratory information management system

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now also fully support comprehensive case-centric clinical data. Up until the late 1970s, the management of laboratory samples and the associated analysis...

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Openclinica

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Openclinica is an open source clinical data management system that is used to collect clinical trial data. REDCap REDCap versus OpenClinica Löbe M, Meineke...

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EudraCT

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(European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials database of all clinical trials of investigational medicinal products...

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Health informatics

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management adverse event reporting regulatory compliance data storage, transfer, processing and analysis repositories of data from completed clinical...

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Clinical pharmacology

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drug management, and psychopharmacology. Modern clinical pharmacologists are also trained in data analysis skills. Their approaches to analyse data can...

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IQVIA

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and commercial outsourcing services. The company offered clinical data management, clinical trial execution services, pharmaceuticals, drug development...

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Tata Consultancy Services

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giants such as Roche, Novartis etc in the areas of clinical data management, biostatistics, clinical programming, pharmacovigilance, and RWE support towards...

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