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Training Courses

GCP training is required by NIAID at least every 3 years per the NIAID Training Standards.  The table below lists training courses offered. Courses may be taken as self-guided, or face-to-face (on-site training per request). Please direct any questions regarding training requirements to the DMID Program Officer or Contracting Officer's Representative (COR).

Training Instructions:

Step 1: Review the list of training courses provided in the table below.

Step 2: To access training courses, select the method of training in the "Course Type" column.

Step 3: Retain certificate of completion at the end of a training course.

Please note: slower internet connections may require additional time for the courses to load. The duration of each course is approximately 1 hour.

For information on other DMID clinical research programs and networks, visit

http://www.niaid.nih.gov/about/organization/dmid/researchers/clinical/Pages/programs.aspx

 
 

 Courses

 
 
  
Description
Course Type
DMID Clinical Quality Management Plan Policy
This course provides comprehensive instruction in the development of Clinical Quality Management Plans. Additionally, the module provides the user with on-demand access to supportive references.
Good Clinical Practice
This course is offered by NIAID and covers the scientific and ethical standards of human subject research, including NIH, FDA, HHS, and international clinical trial policies, guidelines, and regulations.
Protecting Human Research Participants
This course is offered by the NIH Office of Extramural Research. Your institution/IRB/IEC equivalent training is also acceptable.
  
Description
Course Type
45 CFR Part 46
This module provides an overview of the regulations written by the Office for Human Research Protections regarding the protection of human subjects in research.
Adverse Events/Serious Adverse Events
This course covers federal regulations, ICH GCP guidelines and case scenarios related to adverse event and serious adverse events identification and reporting.
DMART Self-Guided Training
The DMART Self-Guided training is a detailed visual representation of the information that is available in the User's Guide. This training system allows the user to view and complete the available sections at their leisure, while maintaining the ability to rewind, pause, and fast forward each section at any time.
DMID Clinical Quality Management Plan Policy
This course provides comprehensive instruction in the development of Clinical Quality Management Plans. Additionally, the module provides the user with on-demand access to supportive references.
DMID Document Library
This course provides overview of how to use the DMID Document Library. To access the DMID Document Library for reference during the training go to https://library.dmidcroms.com.
DMID Regulatory Document File Guidelines
This course describes DMID-specific guidelines regarding regulatory documents that are required for the conduct of clinical research.
DMID Source Documentation Standards
This course describes DMID-specific standards for source documentation of clinical research activities.
Essential Regulatory Documents
This course provides comprehensive instruction on the completion of essential documents per DMID guidelines. Launch this self-directed module to learn how to accurately complete the essential documents for each clinical study in accordance with the DMID Essential Documents Review Worksheet.
Federalwide Assurance (FWA)
This module provides an overview of the Office for Human Research Protections requirements regarding IRB/IEC registration. This module includes changes to FWA terms, forms, and IRB registration requirements which are posted to the OHRP website.
Good Clinical Practice
This course is offered by NIAID and covers the scientific and ethical standards of human subject research, including NIH, FDA, HHS, and international clinical trial policies, guidelines, and regulations.
Informed Consent Documentation and Process
This module provides an overview of the Informed Consent process, including: federal regulations and ICH GCP guidelines, the basic elements of informed consent, roles of the investigator and sponsor, special considerations for vulnerable populations, and quality control.
Investigator Responsibilities
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Investigator Responsibilities - French
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Investigator Responsibilities - Mandarin
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Investigator Responsibilities - Portuguese
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Investigator Responsibilities - Spanish
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Investigator Responsibilities - Thai
This course covers the role and responsibilities of the Principal Investigator (PI), and the delegation of duties by the PI to the investigative site personnel engaged in the conduct of human subjects' research. Those responsibilities are further detailed by reviewing the ICH guidance for the investigator, commitments listed on FDA form 1572, and requirements stated in applicable federal regulations. Featured FDA and OHRP warning letters to Investigators highlight the consequences of noncompliance with regulations. This module is available in other languages.
Protecting Human Research Participants
This course is offered by the NIH Office of Extramural Research. Your institution/IRB/IEC equivalent training is also acceptable.
Study Product Management
This course describes the responsibilities of the sponsor, investigator, pharmacist and monitor regarding the receipt, use, storage and disposition of study products in DMID sponsored clinical trials.