Federal regulation and International Conference on Harmonization (ICH) Good Clinical Practice (E-6) requires investigators and sponsors to retain specific study records associated with the conduct of clinical research. These documents are often referred to as Essential Documents. The Division of Microbiology and Infectious Diseases (DMID) guidances below are specifically directed to DMID clinical trials conducted under an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or international equivalent. The general principles apply to all clinical research.
45 Code of Regulations (CFR) part74.53 also requires awardees to retain records pertinent to an award for a period of three years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report. Investigators should reference the regulation for details.
Investigators should also be aware that they may also have local government or institutional policies for record retention. The most stringent requirement would apply.
- Clinical Site Management page for
- DMID Regulatory File Guidelines
- DMID Source Documentation Standards
- Selected Reference page for
- FDA heading for Investigation New Drug application, sections 312.57 and 312.62 and IDE regulations, section 812.140
- Human Subjects Protections heading- 45CFR46.115
- Institutional Review Boards and Ethical Committees heading
- International Conference on Harmonisation heading-ICH GCP Guidelines E-6 section 8
- Record Retention heading