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Recent Updates to DAIDS Policies, Procedures, and Guidance Documents

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DAIDS SCORE Manual Launch, January 2021

The Division of AIDS (DAIDS) has launched the Site Clinical Operations and Research Essentials (SCORE) Manual. The SCORE Manual is a new site-facing resource which consolidates DAIDS operational and procedural requirements to support the implementation of DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. A presentation on the manual can be found below.

 

New or Updated DAIDS Policies, March 2021

The following DAIDS policies were shared on 29 March 2021; if you have any questions regarding this policy, please email DAIDSProPEP@mail.nih.gov.

Updated DAIDS Storage and Retention of Clinical Records Policy, POL-A15-OPC-015.00. The policy can be found at: https://www.niaid.nih.gov/research/daids-clinical-research-protocol-informed-consent

The policy has been updated to ensure consistency with 45 CFR 46, 21 CFR 50, 21 CFR 56, and ICH E6(R2). This policy supersedes the Enrolling Children (including Adolescents) in Clinical Research: Clinical Research Site Requirements Policy, DWD-POL-CL-007.02, dated July 24, 2009, and the Enrolling Children (including Adolescents) in Clinical Research: Protocol Document Requirements Policy, DWD-POL-CL-008.02, dated November 02, 2015.

 

Major changes to the policy are listed below:

 

The two existing policies were combined into one policy. The policy name was updated to Enrolling Children (including Adolescents) in Clinical Research Requirements Policy to better reflect the contents of the revised policy. The scope of the policy has been modified to apply to all DAIDS-supported clinical research, including DAIDS-sponsored clinical research that plans to enroll children (including adolescents). All the appendices and information from the previous two policies that are out of scope with the revised version of this policy have been removed.


 

New DAIDS Good Documentation Policy (GDP), POL-A15-OPC-014.00, and the Good Documentation Job Aid Appendix, APP-A15-OPC-007.00. The policy and its associated document can be found at: https://www.niaid.nih.gov/research/daids-clinical-research-protocol-informed-consent.

This new policy has been developed to ensure consistency with ICH E6 (R2) Good Clinical Practice: Integrated Addendum to International Conference of Harmonization (ICH) E6 (R1).


 

New DAIDS Clinical Research Policy Collection of Financial Disclosure by Clinical Investigators Conducting DAIDS-sponsored IND Trials, POL-A15-OPC-016.00. The policy can be found at: https://www.niaid.nih.gov/research/daids-clinical-site-implementation-operations.

This new policy has been developed to ensure consistency with the DAIDS Protocol Registration Manual, 21 CFR 312, 21 CFR 812, 21 CFR 54, and Form FDA 1572.

 


 

New Enrolling Children (including Adolescents) in Clinical Research Policy, POL-A15-OPC-008.00, and two associated appendices, Enrolling Children (including Adolescents) in Clinical Research Policy Job Aid and Enrolling Children (including Adolescents) in Clinical Research Policy Tool: Recommended Language. The policy can be found at: https://www.niaid.nih.gov/research/daids-clinical-research-protocol-informed-consent.

The policy has been updated to ensure consistency with 45 CFR 46, 21 CFR 312, 21 CFR Part 11, 21 CFR Part 56, ICH E6(R2), non-US regulatory authorities, and the NIAID Clinical Term of Award. This version supersedes the Storage and Retention of Clinical Research Records Policy, DWD-POL-CL-006.02, dated July 11, 2016.

 

Major changes to the policy are listed below:

 

The scope of the policy has been modified to define the minimum requirements for retaining clinical research records for the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS)-supported clinical research including DAIDS-sponsored clinical research. All the appendices and information from the previous version that are out of scope with the revised version of this policy have been removed.