good clinical data management practices 良好的临床数据管理实践 重点词汇 clinical data 临床资料 ; 临床数据 ; 临床的资料 practices 实践 ; 惯例 ; 习俗 ; 习惯 ; 常规 ; 实际行动 ; 通常的做法 ; 惯常做的事 ; 练习 ; 实行 ; 实习 ; practice的第三人称单数和复数...
GoodClinicalData ManagementPractices PublishedJuly2008 “TheneedforGoodClinicalDataManagementPracticesisnotnew.Intheearly1970s,the PublicHealthServicerecognizedthisneedthroughacontracttoamajorresearchuniversityfor trainingofresearchdatamanagers.However,theneedcontinues,theneedchangesovertime,and theneedforgoodclinicaldata...
CDM is involved in all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of Good Clinical Practice that apply across the board. ...
Code of Good Clinical Practice (GCP)data management and good clinical practicegood clinical practice implementationSummary This chapter contains sections titled: Guidelines of Good Clinical Practice Good Clinical Practice Responsibilities Good Clinical Practice Responsibilities at Participating Sites Implementation ...
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Good Clin·i·cal Prac·tic·es (GCP)(gud klin'i-kăl prak'tis-ĕz) A standard of quality for use in assessment of clinical trials in humans; intended to standardize concepts and data management of health care statistics worldwide. ...
Good Clinical Practice (GCP)The Good Clinical Practice QA (GCPQA) Professional role can vary in its remit depending on the company size and structure. In some companies the GCPQA Professional is responsible for both auditing and advising on GCP and Pharmacovigilance matters whilst in others a ...
ECS‐HSR Coordinator Human Research Protection Office of Research Protections 1 Objectives To provide an overview of Good Clinical Practice as they relate to: ◦ GCP and the NIH adoption of GCPs ◦ PI Responsibilities ◦ Protocol Development and PittPRO ◦ Informed Consent ◦ Study Docume...
Guideline, and is organized as a reference and educational tool to facilitate understanding and implementation of GCP by: describing the clinical research ... A Barton - 《Journal of Epidemiology & Community Health》 被引量: 75发表: 2007年 Using epidemiological data to guide clinical practice: Re...
applicationofdrugregistrations.The relevantactivitiesofclinicaltrialsshouldcomplywiththisguideline. 2.GoodClinicalPractice(GCP)isaqualitystandardfortheoverallconductoftheclinicaltrial, includingtheprotocoldesign,conduct,monitoring,auditing,recording,analyses,summarizingand reportingoftheclinicaltrial. 3.Clinicaltrials...