참고문헌 (16)

1. 1 Guideline on the Content, Management and Archiving of the Clinical Trial Master file (paper and/or electronic) 2018 12 06 Last accessed on 2019 Oct 02 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinicaltrial-master-file-paper/electronic_en.pdf 

2. 2 Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or Electronic) for Management, Audit and Inspection of Clinical Trials. European Medicines Agency 2015 6 15 Last accessed on 2018 Aug 17 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-good-clinical-practicecompliance-relation-trial-master-files-paper/electronicmanagement-audit-inspection-clinical-trials_en.pdf 

3. 3 ICH Harmonization Guidelines, Integrated Addendum to ICH GCP E6 (R1), Guideline for Good Clinical Practice E6 (R2) Last accessed on 2018 Aug 17 Available from: https://www.ich.org 

4. 4 Clinical Trials Regulation (EU) No 536/2014 Last accessed on 2018 Aug 17 Available from: https://ec.europa.eu/health/human-use/clinical-trials/regulation_en 

5. 5 MHRA Reports Critical Inspection Findings Relating to Trial Master File 2016 6 06 Last accessed on 2019 Oct 02 Available from: http://index.canarybooks.com/LinkPages/PDF/Advisor%20Issues/Advisor%20382.pdf 

6. 6 MHRA Guidelines on TMF – Where are we one Year Later 2015 6 Last accessed on 2019 Oct 02 Available from: https://www.veeva.com/wp-content/uploads/2015/06/MHRA-Guidelines-on-TMFs-Where-Are-We-One-Year-Later.pdf 

7. 7 Clinical Trials and Their Patients: The Rising Costs and how to stem the Loss Last accessed 2019 Dec 02 Available from: http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss 

8. 8 GCP Inspectorate.GCP Inspection Metrics Report, Date of Issue 2016 4 11 Last accessed on 2018 Aug 17 Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/517483/GCP_INSPECTIONS_METRICS_2014-2015__final_11-04-16_.pdf 

9. 9 Good Clinical Practice for Clinical trials, Inspection Outcome: Definition of Finding 2014 12 18 Last accessed on 2019 Oct 02 Available from: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials#inspection-outcomes 

10. 10 Veeva 2017 Unified Clinical Operations Survey Last accessed on 2019 Apr 24 Available from: https://www.veeva.com/eu/wp-content/uploads/2017/06/Annual-Report-2017-Unified-Clinical-Operations-Survey-EU.pdf 

11. 11 Veeva 2018 Unified Clinical Operations Survey Last accessed on 2019 Apr 24 Available from: https://www.veeva.com/unified-clinical-survey/ 

12. 12 Guidance for Industry – Computerized Systems Used in Clinical Trials Last accessed on 2019 Feb 05 Available from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance- industrycomputerized-systems-used-clinical-trials 

13. 13 Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application Last accessed on 2019 Oct 02 Available from: https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf 

14. 14 Dylan Jones, Data Migration Pro, Data Migration Research Study 2017 Last accessed on 2019 May 26 Available from: https://www.experian.co.uk/assets/data-quality/data-migration-research-study-2017.pdf 

15. 15 GCP Inspectorate.GCP Inspection Metrics Report, Date of Issue 2017 7 21 Last accessed on 2018 Aug 17 11 May, 2018. Available from: https://www.gov.uk/government/publications/good-clinical-practice-inspection-metrics-2007-to-present 

16. 16 Medicine and Healthcare Products Regulatory Agency (MHRA), GxP Data Integrity Guidance and Definition 2018 3 Last accessed on 2019 Oct 02 Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf