| Document Title |
Research Applicability |
| Protocol and Informed Consent |
| Requirements for Protocol Documents |
Applies to clinical trials |
| Requirements for Informed Consent Development |
Applies to human subjects research |
| Clinical Site |
| Requirements for Human Subject Protection (HSP) and Good Clinical Practice (GCP) Training |
The HSP requirement applies to all human subject research.
The HSP and GCP requirements apply to all clinical trials. |
| Requirements for Source Documentation |
Applies to clinical trials |
| Requirements for Manual of Operational Procedures (MOP) |
Applies to clinical trials |
| Requirements for Clinical Quality Management Plans |
Applies to clinical trials |
| Requirements for On-site Monitoring |
Applies to clinical trials |
| Safety |
| Study Progress and Safety Monitoring |
Applies to clinical trials |
| Expedited Adverse Event Reporting |
Applies to clinical trials |
| Laboratories |
| Requirements for DAIDS Funded and/or Sponsored Laboratories |
Applies to clinical trials |
| Regulatory |
| Determination of Investigational New Drug Application (IND) |
Applies to clinical trials |
| Requirements for Essential Documents |
Applies to clinical trials |
| Protocol Registration |
Applies to clinical trials and to observational studies conducted by the DAIDS-sponsored Clinical Trials Networks |
| Pharmacy |
| Requirements for Pharmacy Facilities |
Applies to clinical trials |
| Requirements for Pharmacy Activities |
Applies to clinical trials |
| Requirements for Pharmacy Personnel |
Applies to clinical trials |
| Data Management and Statistics |
| Requirements for Data Management and Statistics |
Applies to clinical trials |