Division of AIDS (DAIDS) Clinical Research Policy Archive

DAIDS, Protection of Participants, Evaluation and Policy Branch (ProPEP), has developed this central policy archive site to store all historical, outdated, and superseded policy documents. The documents available in PDF format, are made accessible to the public for reference and informational purposes only. These documents should not be regarded as reflecting current U.S. Department of Health and Human Services or DAIDS policy and are not appropriate for providing current guidance. To view more current DAIDS clinical research policies, please see DAIDS Clinical Research Policies and Standard Procedures Documents.

Please note that as DAIDS policy documents undergo revisions, they will be updated using the new DAIDS document numbering convention and format. As documents are transferred to the DAIDS Quality Management System, the version numbering will begin with version 00 to mark the first version with the new quality system. However, the prior versions in the old system are archived and the change history of the document is captured within the document.  This change will be effective beginning February 1, 2019.

Clinical Research Event Reporting and Safety Monitoring

Policy  Policy Number Date Archived
Expedited Adverse Event Reporting Policy VS.03 DWD-POL CL-013.03 June 20, 2016
Expedited Adverse Event Reporting Policy VS.04 - DWD-POL CL-013.04 Aug. 29, 2019

Requirements for Data Management and Statistics for DAIDS Funded and/or Sponsored Clinical Trials

DWD-POL-DM-01.00 Feb. 26, 2021

Critical Events Manual

DWD-POL-RA-017.01  May 14, 2021
Electronic Information Systems Policy POL-A15-OPC-013.00 June 4, 2021
Identification and Classification of Critical Events: Site Responsibilities  DWD-POL-CL-017.01 May 14, 2021

Laboratory and Specimens Management

Policy Policy Number Date Archived
DAIDS Laboratories Clinical Trials Policy QMS VS POL-A-OD-002.00 Sept. 10, 2019
DAIDS Laboratories Clinical Trials Policy VS 3 DWD-POL LB-005.03 Dec. 12, 2013
DAIDS Laboratories Clinical Trials Policy VS 4 DWD-POL LB-005.04 June 21, 2019
Access to Archived Specimens and Data from Completed Study: Women and Infants Transmission Study (WITS) VS.02 DWD-POL LB-012.02 Unknown
Access to Archived Specimens and Data from Completed Study: Women and Infants Transmission Study (WITS) VS.01 DWD-POL LB-012.01 Oct. 1, 2014
Destruction of Clinical Research Specimens Owned by NIAID VS.01 DWD-POL LB-010.01 Oct. 1, 2014

Other Documents

Pharmacy and Study Products Management

Policy Policy Number Date Archived
Requirements for Pharmacy Facilities at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks VS.03 DWD-POL PH-004.03 Sept. 22, 2014
Requirements for Pharmacy Activities at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks VS.03 DWD-POL PH-002.03 Sept. 22, 2014
Requirements for Pharmacy Personnel at DAIDS-Supported Clinical Research Sites Conducting Trials Outside of the HIV/AIDS Clinical Trials Networks VS.03 DWD-POL PH-003.03 Sept. 22, 2014

Protocol and Informed Consent Development

Policy Policy Number Date Archived
Enrolling Children (including Adolescents) in Clinical Research: Protocol Document Requirements VS.01 DWD-POL CL-08.01 Nov. 2, 2015

Enrolling Children (including Adolescents) in Clinical Research

DWD-POL-CL-08.02 March 23, 2021
Requirements for Protocol Documents for DAIDS Funded and/or Sponsored Clinical Trials VS.01 DWD-POL CL-01.00 Oct. 30, 2014

Storage and Retention of Clinical Research Records

DWD-POL-CL-006.02 March 23, 2021
Use of Study Products Not Marketed in the United States Policy VS.01 DWD-POL RA-014.01 Feb. 23, 2015
DAIDS Protocol Documents Policy DWD-POL-CL-01.02 May 20, 2021
DAIDS Protocol Documents Manual   May 20, 2021
DAIDS Protocol Documents Template   May 20, 2021
Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials

DWD-POL-RA-03.00

June 14, 2021
Requirements for Informed Consent Development DWD-POL-CL-02.00 POLICY June 14, 2021
Requirements for Essential Documents DWD-POL-RA-03.00A1 June 14, 2021

Site Implementation and Operations

Delegation of Duties (DOD) Log

Policy Policy Number Date Archived
Delegation of Duties (DOD) Log POL-A15-OPC-002.001 Jan. 26, 2021

Enrolling Children (including Adolescents) in Clinical Research

Policy Policy Number Date Archived
Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements VS.01 DWD-POL CL-007.01 Nov. 2, 2015
Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements DWD-POL-CL-007.02 Jan. 26, 2021

Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training Requirements

Policy Policy Number Date Archived
Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training Requirements DWD-POL CL-03.02 March 16, 2015
Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements DWD-POL-CL-007.02 Jan. 26, 2021
Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Training Requirements DWD-POL-CL-03.03 June 14, 2021

Protocol Registration Policy

Policy Policy Number Date Archived
Protocol Registration Policy VS.04 DWD-POL RA-011.04 May 27, 2015
Protocol Registration Policy VS.05 DWD-POL RA-011.05 March 1, 2019

Other Documents

Requirements for Source Documentation

Policy Policy Number Date Archived
Requirements for Source Documentation DWD-POL-CL-04.00A1 Jan. 26, 2021

Requirements for Manual of Operational Procedures (MOP)

Policy Policy Number Date Archived
Requirements for Manual of Operational Procedures (MOP) DWD-POL-CL-05.00 Jan. 26, 2021

Requirements for On-Site Monitoring

Policy Policy Number Date Archived
Requirements for On-Site Monitoring of DAIDS Funded and/or Sponsored Clinical Trials VS.01 DWD-POL SM-01.00 Aug. 7, 2015
Requirements for On-Site Monitoring DWD-POL-SM-01.02 Jan. 26, 2021

Requirements for Clinical Quality Management Plans

Policy Policy Number Date Archived
Requirements for Clinical Quality Management Plans VS.03 DWD-POL CL-009.03 April 17, 2015
Requirements for Clinical Quality Management Plans VS.04 DWD-POL CL-009.04 July 5, 2019
Requirements for Clinical Quality Management Plans POL-A28-OCS-001.00 Jan. 26, 2021

Storage and Retention of Clinical Research Records

Policy Policy Number Date Archived
Storage and Retention of Clinical Research Records VS.01 DWD-POL CL-006.01 July 11, 2016
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