Basic Definitions

Để nghiên cứu về Nghiên cứu lâm sàng em có thể đọc các tài liệu sau:

• Định nghĩa (Definition):
  • https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
  • https://clinicaltrials.gov/ct2/about-studies/learn#ReasonsForConducting
  • https://www.australianclinicaltrials.gov.au/what-clinical-trial
  • http://www.who.int/topics/clinical_trials/en/
• Thuật ngữ (Glossary): https://clinicaltrials.gov/ct2/about-studies/glossary

• GCP:

  • FDA GCP: https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf - https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf
  • EMA GCP: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
  • WHO GCP: http://apps.who.int/iris/bitstream/10665/43392/1/924159392X_eng.pdf
  • ICH GCP: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf

Nghiên cứu về Quản lý dữ liệu lâm sàng: 

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/
• https://globalhealthtrials.tghn.org/site_media/media/articles/QAWhat_is_clinical_data_management.pdf
• https://www.slideshare.net/emarshad/emerging-trends-in-clinical-data-management
• http://www.gfmer.ch/SRH-Course-2011/Geneva-Workshop/pdf/Clinical-data-management-Huong-2012.pdf

Các hệ thống của công ty bao gồm:

• Hệ thống Quản lý dữ liệu (Clinical Data Management System): CDM - [UM] MEDICLOWD