Data management in clinical research:
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
https://www.slideshare.net/KendallSmith1/fda-nda-submission-support
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf
PDC Monitoring model. https://www.researchgate.net/figure/24256659_fig5_Fig-5-PDC-Monitoring-model-CT-clinical-trial-CRF-Case-Report-Form
Electronic Source Data in Clinical Investigations: https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf
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
GCDMP:
https://www.mci-registrations.com/be-bruga/mci-registrations/scdm/files/gcdmp/en/2013/Full%20GCDMP%20Oct%202013.pdf (Lastest from SCDM)
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466467.pdf
OpenClinica Compliance:
https://forums.openclinica.com/discussion/15244/ema-compliance#latest
https://forums.openclinica.com/categories/regulatory-compliance
eCRF & EDC:
https://tjkuhn.wordpress.com/2008/03/14/the-difference-between-edc-and-ecrf/
Randomization: