PathogenAR Module – HIV/AIDS—Antiretroviral Drugs

The HIV/AIDS: Antiretroviral Drugs module is part of the Pathogens in Augmented Reality (PathogenAR) mobile app. Acquired immunodeficiency syndrome (AIDS) is the most severe phase of infection with human immunodeficiency virus (HIV).  There is no effective cure for HIV.  However, by taking a combination of antiretroviral drugs, people with HIV can now live long and healthy lives.  Antiretroviral drugs target specific proteins which are required for infection.

PathogenAR Module – COVID-19—How SARS-CoV-2 binds to host cells

The COVID-19: How SARS-CoV-2 binds to host cells module is part of the Pathogens in Augmented Reality (PathogenAR) mobile app. COVID-19 is a severe respiratory infection caused by the SARS-CoV-2 virus.  In order to infect host cells, SARS-CoV-2 has a surface protein which can specifically bind to another surface protein on host cells.  Disrupting this interaction is key to several vaccines and therapeutics currently in development.

TB Portals

The NIAID TB Portals Program is a multi-national collaboration for tuberculosis (TB) data sharing and analysis to advance TB research.

TB Portals is a web-based, open-access repository of multi-domain TB data and tools for its analysis. It offers linked socioeconomic/geographic, clinical, laboratory, radiological, and genomic data from over 3,400 international TB patient cases.

Researchers can explore and analyze these data through any of the tools. TB Portals data are also available for download to support your own research.

Jill R. Harper, Ph.D.

Site Clinical Operations and Research Essentials (SCORE) Related Training

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 (SCORE) Manual was developed to describe the operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored studies within the DAIDS Clinical Trials Networks. However, many sections of the manual are broadly applicable to all clinical research and must be followed by CRSs conducting these studies. Access the DAIDS SCORE Manual here.

For the most frequently asked questions about the DAIDS Score Manual, see the SCORE FAQ page. 

Please see the links below for DLP training related to topics in the SCORE Manual.

Related Training Courses on the DLP

NameDescription and Audience
Corrective and Preventative Actions (CAPA)Define what a CAPA is, how it is developed, and when it is used. All clinical and pharmacy staff members who will be addressing queries and CSM issues should take this training.
Clinical Quality Management Plan

Four modules regarding site Clinical Quality Management Plan (CQMP) requirements, and associated tools. Site staff members who will be involved with Quality Management at the site should take this training.

  1. Introduction to the CQMP
  2. Participant Chart Review Tool
  3. Regulatory File Review Tool
  4. CRS Quality Assurance Summary Report
Clinical Site Monitoring (CSM) System TrainingOverview of the DAIDS Clinical Site Monitoring (CSM) System within the NIAID CRMS. Clinic and pharmacy staff members who will interact with clinical site monitors and address monitoring issues in the CSM system should take this training.
DAIDS Protocol Registration System (DPRS)Required training to access the DPRS. Staff members who will use the DPRS to prepare, submit, and track protocol registration documents must take this training.
DAIDS Expedited Adverse Event (EAE) Reporting eLearning Course

Review of DAIDS Expedited Adverse Event Reporting process and the system (DAERS) used for reporting . Completion of training is required for access to the DAERS. Those who must use DAERS include Staff members listed as:

  • 'Submitter' must be listed on FDA Form 1572 or an Investigator of Record (IOR) agreement (must be a physician)
  • 'Reporter(s)' is one who initiates the report in the system on behalf of the submitter
Essential DocumentsThis course covers the purpose of essential documents and how to accurately generate, complete, maintain, and/or submit them (to Institutional Review Boards/Ethics Committees, regulatory authorities, or DAIDS) during a clinical trial.
Good Clinical Laboratory PracticeThis training describes the standards to be followed by laboratories that process or perform analysis or evaluation of clinical trial samples. Training is required for international clinical laboratory staff involved in specimen processing and testing.
Inspection Awareness & Preparedness for CRS InspectionsThree modules giving an overview of what regulatory inspections at a CRS involve, what can be expected, and how to prepare. All personnel who would expect to be involved with a site inspection should take this training.
Investigator of Record (IoR) ResponsibilitiesThis course provides an overview of the primary responsibilities of the Investigator of Record (IoR), sometimes referred to as the Principal Investigator (PI), to successfully conduct clinical trials that are sponsored and/or supported by DAIDS. CRS Leader, IoR, Sub Investigator, or anyone designated IoR responsibilities should take this training.
Investigator of Record (IoR) Study Product ManagementThis course reviews the Investigator of Record’s study product management oversight responsibilities. CRS Leader, IoR, Sub Investigator, or anyone designated IoR responsibilities should take this training.
Monitoring 101Overview of the DAIDS Monitoring process. Site staff members who will be involved with DAIDS monitoring visits or address monitoring issues should take this training.
Source DocumentationThis course covers the role that source documents and data play in clinical trials, explains how to apply the ALCOA-C principles and other Good Documentation Practice requirements, introduces the process of de-identification, and discusses how to analyze, correct, and prevent source documentation errors.
Protocol Registration: Policy and Manual TrainingOverview of the DAIDS Protocol Registration Policy and Manual. It is highly recommended that staff members who will be working with site regulatory and protocol related documents take this training.
GCP/HSP Training Option: DAIDS eLearningDuration of 4 hours, this course fulfills both the GCP and HSP requirement.
HSP Training Option: ACRP eLearningDuration of 2.25 hours, this course ONLY fulfills the HSP requirement, NOT the GCP requirement.

Access a full list of DAIDS Required trainings

Office for Policy in Clinical Research Operations (OPCRO) Related Training

Welcome to the OPCRO Group Training Pages on the DAIDS Learning Portal.  Please use the links below to visit training pages for groups within OPCRO.  You will find general information about each group and a list of related DLP trainings.

DAIDS Safety and Pharmacovigilance Team (SPT) Training Page

The Safety and Pharmacovigilance Team (SPT) within the Office for Policy in Clinical Research Operations (OPCRO) serve as subject matter experts and advisors to DAIDS and external stakeholders in matters related to safety and pharmacovigilance.

Visit SPT

DAIDS Protection of Participants, Evaluation and Policy (ProPEP) Branch Training Page

ProPEP staff serve as the Division’s Human Subjects Protection experts and oversee the development and maintenance of DAIDS’ Clinical Research Policies.

Visit ProPEP

Protocol Registration Team (PRT) Training Page

The DAIDS Protocol Registration Team (PRT) establishes internal procedures and processes for DAIDS RSC Protocol Registration Office (PRO). DAIDS PRO receives and processes all protocol registration materials submitted by Clinical Research Sites (CRSs) participating in DAIDS-supported and/or -sponsored clinical trials.

Visit PRT

SimpleITK

Do you need an easy, quick way to analyze images? The SimpleITK platform allows researchers to load, process, and analyze images using the programming language they are most familiar with, including C++, Python, R, Java, and more.

DAIDS Age and Identity Verification Frequently Asked Questions

These FAQs are related to the requirements for the Age and Identity Verification standard operating procedures (SOPs) as outlined in the DAIDS Site Clinical Operations and Research Essentials (SCORE) manual in the section on Screening, Enrollment, and Unblinding. Please contact your OCSO PO with any additional questions,

DAIDS SCORE Manual Frequently Asked Questions

University of Minnesota Trial Shows Hydroxychloroquine Does Not Prevent COVID-19 in High-Risk Health Care Workers

Link Type
Funded-research
Media Type
Article
Publish or Event Date
Link URL
https://med.umn.edu/news-events/university-minnesota-trial-shows-hydroxychloroquine-does-not-prevent-covid-19-high-risk-health-care-workers
Research Institution
University of Minnesota Medical School
Short Title
University of Minnesota Trial Shows Hydroxychloroquine Does Not Prevent COVID-19 in High-Risk Health Care Workers
Content Coordinator
Claudia Wair
Content Manager
Kathy Donbeck
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