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
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) 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
- Food and Drug Administration
- Training Opportunities page for
- Electronic Data Entry (authorized users only)
Content last reviewed on November 13, 2014