Table of Clinical Research Applicability

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
Content last reviewed on