Training Required by DAIDS

DAIDS has a number of training options available to all Clinical Research Site (CRS) staff. These trainings help you understand policies, procedures, and systems in a number of topic areas. Some courses are required of CRS staff for the site to be in compliance with DAIDS policies and procedures. Please review the table below and complete the training that is required for you. For any questions about DAIDS requirements at your site, contact your Program Officer (PO). For any technical questions about the trainings, contact the DAIDS Training Support Team.

The CRS Leader is responsible for ensuring that all CRS staff are properly trained, and trainings required for each staff role are at their discretion. Each site is responsible for maintaining documentation of training for all staff. These records should be made available to monitors upon request. Please note this page only details the DAIDS required trainings and the site may also need to consult the Networks and their institutions to ensure other required Network, institutional and regional trainings are completed.

Please also see the far right column to determine if the required courses apply to known to DAIDS or New to DAIDS sites, as defined in your CTU transition letter and CTU Transition Packet.


 Human Subjects Protection and Good Clinical Practice
Course Who should take this training? Training Details CTU Transition 2021
DAIDS Good Clinical Practice (GCP) eLearning Course Anyone working at a clinical research site with study participants or participant data. 

This course fulfills BOTH of DAIDS training requirements on Human Subjects Protection (HSP) and Good Clinical Practice (GCP). 

After August 2021, this course will be offered in Spanish and Portuguese. 

Additionally, many of our affiliate institutions offer courses that fulfill the requirements for GCP. If you want to use an institutional course for the requirement you will need to send a copy of the agenda and the certificate of completion to your DAIDS Program Officer for consideration. 

Note: if you have previously completed a course that fulfills only the DAIDS GCP requirements, you can take part in our partnership with the Association of Clinical Research Professionals (ACRP) who provide a course that fulfills ONLY the DAIDS Human Subjects Protection (HSP) training requirements.

Known & New CRS

 

Investigator of Record (IoR) Responsibilities
Course Who should take this training? Training Details CTU Transition 2021
IoR Responsibilities CRS Leader, IoR, Sub Investigator, or anyone designated IoR responsibilities.

The Investigator of Record Responsibilities (IoR) 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.

Known & New CRS

 

Clinical Research Records and Monitoring
Course Who should take this training? Training Details CTU Transition 2021
Source Documentation Anyone working on a clinical trial at the site. This 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. Known & New CRS
Essential Documents Anyone working on a clinical trial at the site. This 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. Known & New CRS

CQMP

Anyone working on a clinical trial at the site.

The Clinical Quality Management Plan (CQMP) course is comprised of 4 modules and covers DAIDS Requirements for the Clinical Quality Management Plan (CQMP), which can help each Clinical Research Site (CRS) with quality oversight of clinical research conduct. Modules also cover in depth how to use the Participant Chart Review Tool, Regulatory Review Tool, and QA Summary Tool provided by DAIDS. 

  1. Introduction
  2. Participant Chart Review Tool
  3. Regulatory Review Tool
  4. QA Summary Tool
Known & New CRS
CAPA Those personnel with a key role in each functional area – lab, clinic, pharmacy, etc. - who can speak to site processes. The Corrective and Preventive Action (CAPA) course covers the CAPA process, exploring benefits of implementation, root cause analysis tools, techniques, and application, as well as methods to evaluate CAPA effectiveness. Known & New CRS
Monitoring 101 Anyone working on a clinical trial at the site.

This course covers the requirements of monitoring per the ICH Good Clinical Practices Guidelines (ICH E6), as well as the roles and responsibilities of the sponsor, the site monitors, clinical research site staff, and other parties who play an integral role in the monitoring process. The DAIDS risk-based approach to monitoring is also covered.

New CRS (or new staff) 
Inspection Awareness & Preparedness for CRS Inspections Staff members who have been assigned a key role in the study per the site SOP on CRS Regulatory Inspection Preparedness.    

This course is comprised of 3 modules which describe the regulatory Inspection process at sites and give guidance on how sites can prepare for an inspection.  

  1. Regulatory Inspection Awareness – Introduction
  2. Regulatory Inspection Awareness – CRS Inspections
  3. Regulatory Inspection Preparedness for Sites

Known & New CRS

 

DAIDS Systems Trainings (Modules to access NIAID CRMS)
Course Who should take this training? Training Details CTU Transition 2021
CSM Clinic and pharmacy staff members who will interact with clinical site monitors and address monitoring issues in the CSM system.

To gain access to the Clinical Site Monitoring (CSM) module perform the following steps:

  • Complete the CSM training
  • The NIAID CRMS Support Team will be automatically notified of your completion of the training. Please have your CRS Coordinator or CRS Leader request your access to the system by emailing NIAID CRMS Support with your name and role.  

For more information on access to the CSM module on the NIAID CRMS system please review the Introduction to DAIDS Systems section in the SCORE Manual.

New CRS (or new staff) 
DAERS

Clinical Research Site members who use DAERS to report and submit Expedited Adverse Events (EAEs) to DAIDS, including:

  • "Submitter" on FDA Form 1572 or Investigator of Record (IOR) agreement (must be a physician)
  • "Reporter(s)" who initiates the report in the system on behalf of the submitter.

To gain access to the DAIDS Adverse Experience Reporting System (DAERS) module perform the following steps:

  • Complete the DAERS training
  • The NIAID CRMS Support Team will be automatically notified of your completion of the training. Please have your CRS Coordinator or CRS Leader request your access to the system by emailing NIAID CRMS Support with your name and role or making the request in the DAERS Site Enrollment Module (SEM).  

Note: CRS Leader/Coordinator action for Site Enrollment Module not applicable for DAIDS Non-Network sites. Follow the requirements specified in the study-specific site activation checklist.

For more information on access to the DAERS module on the NIAID CRMS system please review the Introduction to DAIDS Systems section in the SCORE Manual.

New CRS (or new staff) 

DPRS

Staff members who will use the DPRS to prepare, submit, and track protocol registration documents.

To gain access to the DAIDS Protocol Registration System (DPRS) module perform the following steps:

  • Complete the DPRS training
  • The NIAID CRMS Support Team will be automatically notified of your completion of the training. Please have your CRS Coordinator or CRS Leader request your access to the system by emailing NIAID CRMS Support with your name and role.  

For more information on access to the DPRS module on the NIAID CRMS system please review the Introduction to DAIDS Systems section in the SCORE Manual.

New CRS (or new staff) 

 

Laboratory
Course Who should take this training? Training Details CTU Transition 2021
GCLP All international clinical laboratory staff involved in specimen processing and testing. This should include laboratory staff as well as study nurses and any other non-lab staff performing testing in the clinical laboratory.

The Good Clinical Laboratory Practice (GCLP) course 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.

Known & New CRS

 

Pharmacy
Course Who should take this training? Training Details CTU Transition 2021
DAIDS Clinical Trials Networks Pharmacy Guidelines Training Pharmacists of Record (PoRs) and Associate Pharmacists (APs)

This course provides an overview of the Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks and is composed of six modules as follows:

  • General Overview
  • Oversight of Pharmacy Facilities
  • Pharmacist Administrative Responsibilities
  • Study Product Management Responsibilities Part 1
  • Study Product Management Responsibilities Part 2
  • Pharmacy Incident Report Form (IRF)


Known & New CRS