 |
DAIDS Policy # DWD-POL-CL-013.03, Expedited Adverse Event Reporting, dated 28 April 2010 |
 |
|
|
Latest DAIDS Policies and SOPs |
 |
|
|
National Institutes of Health (NIH)
|
|
|
- NIH Revitalization Act of 1993
|
|
|
|
|
- NIH Brochure - Research on Human Specimens
|
|
|
|
|
- Guidance on Data and Safety Monitoring for Phase I and II Trials
|
|
|
|
|
- Notice to Grantees/Contractors re: FDA-NIH Interaction
|
|
|
|
|
- Guidelines on Inclusion of Women/Minorities as Clinical Research Subjects
|
|
|
|
|
- Required Education in Protection of Human Research Participants
|
|
|
|
Guides to IND and Human Subject Regulations, Policies and Guidance - Applicable to DAIDS-Sponsored Clinical Trials - Food and Drug Administration (FDA)
|
|
|
- 21 CFR Part 312 - Investigational New Drug Application
|
|
|
|
|
- 21 CFR Part 312.32 - IND Safety Reports
|
|
|
|
|
- 21 CFR Part 50 - Protection of Human Subjects
|
|
|
|
|
- 21 CFR Part 54 - Financial Disclosure by Clinical Investigators
|
|
|
|
|
- FDA Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators
|
|
|
|
|
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice
|
|
|
|
Office for Human Research Protections (OHRP)
|
|
|
|
|
|
|
|
- 45 CFR Part 46--Protection of Human Subjects
|
|
|
|
|
- 2003 - Certificates of Confidentiality
|
|
|
|
|
- 2003 - Guidance on Approving Research Involving Prisoners
|
|
|
|
|
- 1997 - Storage of Tissue/Cell Repositories
|
|
|
|
|
- 1993 - IRB Review of DAIDS clinical trials
|
|
|
|
|
- 1988 - PHS Policy on Informing Those Tested About HIV Serostatus
|
|
|
|
|
- 1984 - Guidance for Institutional Review Boards for AIDS Studies
|
|
|