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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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Data Management

This page contains information and links for Division of MIcrobiology and Infectious Diseases (DMID) staff and clinical site investigators concerning the handling of clinical research data.

DMID Policies

EMMES-Statistical and Data Coordinating Center (SDCC) for many DMID-sponsored contract clinical trials. (authorized users only)

Related Links

  • Selected References for
    • Food and Drug Administration¬†
      • 21 Code of Federal Regulation Part11 for regulation on electronic data
      • 21 CFR 312 for IND reporting requirements
      • 21CFR 812 for IDE reporting requirements
      • Electronic Source Documentation in Clinical Investigations- Draft
      • FDA Guidance for Sponsors, Clinical Investigators and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
    • Good Clinical Practices for International Conference on Harmonisation (ICH) Guidances
      • Good Clinical Practices (GCP) E6
      • Clinical Safety E1-2F
      • Clinical Study Reports E3
      • Guidance on General Considerations for Clinical Trials E8
      • Statistical Principles for Clinical Trials E-9
      • Quality Risk Management Q9
  • Training Opportunities page for
    • Electronic Data Entry (authorized users only)

Last Updated March 13, 2013