Protocol and Informed Consent
| Document Title | Research Applicability |
|---|---|
| Requirements for Protocol Documents | Applies to clinical trials |
| Requirements for Informed Consent Development | Applies to human subjects research |
Clinical Site
| Document Title | Research Applicability |
|---|---|
| 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
| Document Title | Research Applicability |
|---|---|
| Study Progress and Safety Monitoring | Applies to clinical trials |
| Expedited Adverse Event Reporting | Applies to clinical trials |
Laboratories
| Document Title | Research Applicability |
|---|---|
| Requirements for DAIDS Funded and/or Sponsored Laboratories | Applies to clinical trials |
Regulatory
| Document Title | Research Applicability |
|---|---|
| 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
| Document Title | Research Applicability |
|---|---|
| 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
| Document Title | Research Applicability |
|---|---|
| Requirements for Data Management and Statistics | Applies to clinical trials |