Co-enrollment Prevention (CEP) HIPAA/Privacy Frequently Asked Questions

Co-Enrollment Prevention (CEP) Frequently Asked Questions

NIH Awards More than $20 Million to International HIV Database Centers

The National Institutes of Health has renewed grants to seven regional centers that compose the International epidemiology Databases to Evaluate AIDS (IeDEA), awarding $20.8 million in first-year funding. The 15-year-old IeDEA program efficiently advances knowledge about HIV by pooling and analyzing de-identified health data from more than two million people with HIV on five continents to answer research questions that individual studies cannot address. The grants are expected to last five years and to total an estimated $100 million.  

Contact

Submit a Media Request

Contact the NIAID News & Science Writing Branch.

301-402-1663
niaidnews@niaid.nih.gov
All Media Contacts

Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination

NIAID is recruiting NIH staff members to help researchers make discoveries about COVID-19 and influenza including learning about long-term immunity in people who receive COVID-19 and/or flu vaccines.

To End HIV Epidemic, We Must Address Health Disparities

NIH reports that scientific strides in HIV treatment and prevention have reduced transmissions and HIV-related deaths significantly in the US.

Contact

Submit a Media Request

Contact the NIAID News & Science Writing Branch.

301-402-1663
niaidnews@niaid.nih.gov
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Antibody Infusions Prevent Acquisition of Some HIV Strains, NIH Studies Find

NIH finds that an investigational anti-HIV antibody prevented acquisition of some HIV strains, but did not significantly reduce overall acquisition.

Contact

Submit a Media Request

Contact the NIAID News & Science Writing Branch.

301-402-1663
niaidnews@niaid.nih.gov
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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

DAIDS SCORE Manual Frequently Asked Questions

NIH Announces Restructured HIV Clinical Trials Networks

NIAID announced the clinical investigators and institutions that will lead four NIH HIV clinical trials networks over the next seven years.

Contact

Submit a Media Request

Contact the NIAID News & Science Writing Branch.

301-402-1663
niaidnews@niaid.nih.gov
All Media Contacts

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