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 |