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Sunday, March 9, 2008

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:
Pharmaceutical Research And Manufacturer’s Industry Perspective of about ICH GCP:
Frequently asked questions about ICH and its guidelines:
Brief Introduction to the ICH Guidelines:
Guideline for Industry Structure and Content of Clinical Study Reports:
Guidance for IndustryE6 Good Clinical Practice:Consolidated Guidance

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