Table of Clinical Research Applicability

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

 

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