Data Management

DMID Policies

• datadistribution.pdf (98.72 KB)
• unblindingindividuals.pdf (215.49 KB)
• datamanagement.pdf (100.07 KB)
• guidance-terminology-biospecimens-data.pdf (406.44 KB)
• independent-data-safety-oversight-dmid-clinical-research.pdf (308.83 KB)
• statistical-analysis-plan.pdf (248.64 KB)
• dmid-dm-pol-00001-sdcc.pdf (259.32 KB)

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

​Additional Information

• 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) Guidance's
    • 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)