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관련링크 : http://www.oecd.org/sti/biotech/38839788.pdf 

OECD Guidelines for Quality Assurance in Genetic Testing

 

 

http://www.oecd.org/sti/biotech/oecdguidelinesforqualityassuranceingenetictesting.htm

 

 

OECD member countries have adopted an agreed set of Guidelines for Quality Assurance in Molecular Genetic Testing. The Guidelines address genetic testing for variations in germ line DNA sequences or products arising directly from changes in heritable genomic sequences that predict effects on the health, or influence the health management, of an individual. They focus on molecular genetic testing for the diagnosis of a particular disease or condition and predictive genetic testing often carried out before any clinical signs of the disease or condition appear. They are relevant to tests for heritable DNA variants that predict the response profile of an individual to a drug or course of therapy and that affect susceptibility to disease, patient prognosis, counselling, treatment and family planning. They do not address testing carried out only for research purposes.

 

 

Table of Contents

 

Background..............................................................................5

Preface ......................................................................................7

Part I. Principles and Best Practices for Quality Assurance of Molecular Genetic Testing......................11

   1. Scope............................................................................11

   2. Principles and best practices .............................13

  General principles and best practices for molecular genetic testing ..........................13

  Quality assurance systems in molecular genetic testing..............................................14

  Proficiency testing: monitoring the quality of laboratory performance......................16

  Quality of result reporting...........................................................................................17

  Education and training standards for laboratory personnel.......................................19

 

Part II. Annotations.........................................................................................................21

  Introduction..................................................................................................................23

  General terminology ....................................................................................................23

  General principles and practices for molecular genetic testing ..................................26

  Quality assurance systems in molecular genetic testing..............................................29

  Proficiency testing: Monitoring the quality of laboratory performance......................31

  Ensuring quality in molecular genetic test result reporting.........................................33

  Education and training standards for laboratory personnel .......................................35

 

Glossary ...........................................................................................................................37

 

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63 국외 NCI best practices for biospecimen resources(2016) file 2017-07-12 144
» 국외 OECD Guidelines for Quality Assurance in Genetic Testing(2007) 2017-07-12 138
61 국외 International Compilation of Human Research Standards(2017) /HHS.gov file 2017-07-07 161
60 국외 의료기기에 관한 지침( Directive 93/75/CEE du Conseil relative aux dispositifs medicaux) 2017-04-07 116
59 국내 2017 실무자를 위한 비영리·공익 법인 관리·감독 업무 편람 file 2017-03-27 709
58 국외 Guidelines for Stem cell science and Clinical translation file 2016-05-16 529
57 국내 2016 장기이식 관리 업무 안내 file 2016-04-25 579
56 국내 2016 장기·인체조직 등록기관 업무가이드 file 2016-04-25 301
55 국외 나고야의정서(Nagoya Protocol, ABS) file 2016-04-07 969
54 국내 생물자원센터를 위한 OECD 모범운영지침 2016-04-07 167
53 국내 종양성 질환자원 임상정보수집 표준화를 위한 가이드라인(2015) file 2016-04-06 178
52 국내 2015 인체유래물은행 표준운영지침 file 2016-04-06 768
51 국외 Guide on the decision-making process regarding medical treatment in end-of-life situations 2016-03-29 242
50 국외 Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions 2016-02-15 166
49 선언 국제의사 윤리헌장 (International Code of Medical Ethics ) 2015-09-25 532
48 국내 2015 난임부부 지원사업 일부 개정 안내[지침 및 양식] file 2015-09-17 394