Title 21 Code Of Federal Regulations (21 CFR Part 11)Electronic Records; Eletronics Signature

Trial eCRF Pages
Adverse Event:
http://www.sapmaker.com/EDC/eCRF_AE.aspx
Study Medication Exposure (EX):
http://www.sapmaker.com/EDC/eCRF_EX.aspx
Demographics (DM):
http://www.sapmaker.com/EDC/eCRF_DM.aspx
Concomitant Medication (CM)
http://www.sapmaker.com/EDC/eCRF_CM.aspx
Vital Signs (VS)
http://www.sapmaker.com/EDC/eCRF_VS.aspx
Medical History (MH):
http://www.sapmaker.com/EDC/eCRF_MH.aspx
Disease Status at Baseline:
http://www.sapmaker.com/EDC/eCRF_BASECAT.aspx
Change from Baseline Disease Status:
http://www.sapmaker.com/EDC/eCRF_CFBCAT.aspx
CDISC Metadata of ClinTrialStat eCRF Builder Created ODM Domains: http://www.sapmaker.com/EDC/eCRF%20SDTM.xml

Title 21 Code of Federal Regulations (21 CFR Part 11)

Electronic Records; Electronic Signature

http://www.fda.gov/ora/compliance_ref/part11/
Information About ICH-GCP and their Guidelines:

ICH Guidelines:

http://www.fda.gov/CDER/guidance/959fnl.pdf

Pharmaceutical Research And Manufacturer’s Industry Perspective of about ICH GCP:

http://www.raninstitute.com/PDF_PP_Docs/SENT%20FILE%2004001_June15_Millard_David_Vers1.pdf

Frequently asked questions about ICH and its guidelines:

http://www.ich.org/cache/compo/276-254-1.html

Brief Introduction to the ICH Guidelines:

http://www.icssc.org/Presentations/NewDelhi2007/3BriefIntrototheICHGuidelinesIndia2007.pdf

Guideline for Industry Structure and Content of Clinical Study Reports:

http://www.fda.gov/cder/guidance/iche3.pdf

Guidance for IndustryE6 Good Clinical Practice:Consolidated Guidance

http://www.fda.gov/CDER/guidance/959fnl.pdf