Clinical Data Management

Data management in clinical research:

• 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

• https://community.openclinica.com/sites/fileuploads/akaza/cms-community/Data%20Management%20and%20OpenClinica%C2%AE%20Infrastructure%20Final-Elisa%20Priest.pdf

• https://www.slideshare.net/KendallSmith1/fda-nda-submission-support

• https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf

• http://consulting.inventivhealth.com/articles/Realizing_the_Promise_of_Clinical_EDC_A_Practical_Guide.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: 

GCDMP:

• https://www.mci-registrations.com/be-bruga/mci-registrations/scdm/files/gcdmp/en/2013/Full%20GCDMP%20Oct%202013.pdf (Lastest from SCDM)

• http://www.bvv.sld.cu/docs/libros/__a_119376865712.pdf

• https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466467.pdf

OpenClinica Compliance:

• https://forums.openclinica.com/categories/regulatory-compliance

• https://community.openclinica.com/sites/fileuploads/akaza/cms-community/marketing/Part11_compliance_OC15.pdf

• https://community.openclinica.com/sites/fileuploads/akaza/cms-community/Data%20Management%20and%20OpenClinica%C2%AE%20Infrastructure%20Final-Elisa%20Priest.pdf

eCRF & EDC:

Randomization: