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This DAIDS SCORE Manual document provides information about essential documents which demonstrate compliance with various local laws and regulations.

Last Reviewed: May 16, 2022

This DAIDS SCORE Manual appendix provides a detailed list of essential documents and a description of their purpose.

Last Reviewed: May 16, 2022

This policy provides guidance to DAIDS' collaborators about the requirements for essential documents collected during DAIDS sponsored clinical trials.

Last Reviewed: March 15, 2023

Recordkeeping requirements for Division of Allergy, Immunology, and Transplantation (DAIT)-sponsored clinical research

Last Reviewed: November 25, 2019

Clinical research policies and standard procedure documents for NIAID microbiology and infectious diseases research

Last Reviewed: February 14, 2025

Policies and standard operating procedures (SOPs) related to NIAID Division of AIDS clinical research protocol and informed consent development.

Last Reviewed: December 11, 2024

Requirements for the development of informed consent documents for Division of AIDS (DAIDS)-sponsored clinical research studies.

Last Reviewed: March 15, 2023

DAIDS requires CRSs conducting clinical research that meets the National Institute of Health (NIH) definition of a clinical trial to follow all applicable NIH, National Institute of Allergy and Infectious Diseases (NIAID), DAIDS policies and procedures, as well as DAIDS Clinical Trials Networks processes and procedures. The Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials

Last Reviewed: December 24, 2020

A NIAID manual for Clinical Research Sites (CRSs) which consolidates operational requirements and provides tools to facilitate compliance with these requirements.

Last Reviewed: November 4, 2024

This document outlines defense levels of the immune, lymphatic, blood systems and the basic immunological concepts.

Last Reviewed: February 9, 2018

This document outlines the use of DNA sequencing and computers to analyze biological data.

Last Reviewed: February 8, 2018

This document incudes detailed instructions for the general use of the DAIDS protocol specific informed consent template, updated in February 2016.

Last Reviewed: August 6, 2019

This document incudes detailed instructions for the general use of the DAIDS protocol specific informed consent template, updated in 2013.

Last Reviewed: August 6, 2019

This memo provides DAIDS' guidance for documenting informed consent during the COVID-19 national emergency.

Last Reviewed: April 8, 2020

This document incudes detailed instructions for the general use of the DAIDS protocol specific informed consent template, updated in 2012.

Last Reviewed: August 6, 2019

NIAID cannot correct an error spotted in your application after the receipt deadline on your behalf, even if an overlooked content error would render your application nonresponsive to an initiative's requirements.

Published: November 17, 2021

This memo outlines DAIDS requirements related to the informed consent process and recent updates.

Last Reviewed: September 12, 2021

This policy provides guidance for the development of Informed Consent for DAIDS funded and/or sponsored human subjects clinical research.

Last Reviewed: July 12, 2013

Last Reviewed: January 31, 2022

NIH Opening Statement Senate LHHS FY 2019 Hearing: Prepared statement of Lawrence A. Tabak, D.D.S., PH.D., Principal Deputy Director, Office of the Director

Last Reviewed: August 16, 2018

DAIDS Specific Informed Consent Template General Use. Version 2.0; Posted 5 December 2017

Last Reviewed: December 1, 2017

Lenette Lu, M.D., Ph.D., of the Massachusetts General Hospital K08 sample application

Last Reviewed: March 31, 2025

This WORD document provides a tool for evaluating organization review, coordinate and maintain oversight of all applications and proposal

Last Reviewed: August 6, 2019

This document explains the Urban Environment and Childhood Asthma (URECA) birth cohort study.

Last Reviewed: November 27, 2019

This document proposes tests in vaccine trials to compare the vaccine and placebo groups in randomized vaccine trials.

Last Reviewed: August 6, 2019