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

• Expanded Distribution of Clinical Research Endpoint Data
• Unblinding Individual Participants in DMID Clinical Research
• Data Management
• Guidance on Terminology of Biospecimens and Data
• Independent Data and Safety Oversight for DMID Clinical Research
• Statistical Analysis Plan

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)