The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners.
Provides learners with key information on the management of controlled substances in clinical research settings.
Helps develop leadership skills to meet today’s changing, diverse, and dynamic environments.
Strategies for implementing compliance with GDP, as well as standards and procedures for accurately completing Records required for current cGMP.
Describes regulatory requirements for a CAPA system in the biotech industry.
Describes FDA’s regulatory controls for common marketing approval pathways for the classes of medical devices, and explains the Code of Federal Regulations that pertain to medical device approval in the U.S.
Explains requirements to establish and maintain regulatory compliance with 21 CFR Part 111 cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
This webinar discusses the practical and strategic approaches to interacting with the FDA during medical device development.
Discusses the FDA’s approach to inspecting GMP facilities and the ways that facilities can prepare for inspections.
Covers the best practices of data management and security for graduate student researchers.
Discusses BYOD study best practices, implementation, and Institutional Review Board (IRB) review.
An in-depth introduction to GMP for pharmaceuticals.
An in-depth review of the development and execution of protocols.
An introduction for researchers on university technology transfer and commercialization processes.
Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.
Covers the use of facial recognition systems in research and healthcare.
This course focuses on effective practices, guidelines, and strategies for communicating and presenting research findings.
This course covers the core requirements of the federal Family Educational Rights and Privacy Act (FERPA).
This course focuses on developing the knowledge and skill base necessary for being a successful healthcare ethics committee member.
Discusses key elements of the new 2020 regulations, how they affect the institutional community, and what you should know to implement best practices into revised Title IX procedures and policies.
Discusses strategies to address researcher noncompliance with IRB-approved protocols.
A detailed review of radiation safety for research and medical institutions.
Explore key ethical, export, security, intellectual property, and transparency requirements related to international engagement.
This course provides an introduction to the False Claims Act ideally suited for faculty, researchers, and staff at research organizations.
A focused discussion for individuals who work with federally sponsored awards, PIs, and other members of the research team.
Foundational course that orients and prepares learners to engage with the scholarly publication process in an informed way.
A primer for understanding the sponsor-investigator role and responsibilities in clinical research.
Provides an overall approach to and best practices for partnering with technology companies to design and conduct research.
Provides instruction on how to improve your teaching and training skills in a variety of settings.
This course offers information about disaster planning and business continuity to those responsible for research oversight.
This course provides an overview of research administration.
CTrials helps grow sponsored research programs by taking on the many administrative challenges inherent in managing clinical trials.
Protocol Builder is an online protocol writing and collaboration platform that also speed up your pre-review turnaround times.
N2 is a not-for-profit alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity.
BIC Study Foundation is a resource for those who want to take CITI Program courses in Korean. They are a certified training provider by the Korean FDA/MAFRA for HRPP and ACU Programs.
Highlighted below are just a few select subscribers & collaborators.
New Course – Controlled Substances in Clinical Research Settings
This in-depth course provides learners with an overview of the U.S. federal and select state laws and regulations that govern the use of controlled substances in clinical research, including the requirements for their acquisition, usage, storage, final disposition, and recordkeeping.Read the article
New Resource and Request for Input on NIH Policy for Data Management and Sharing
As part of the push to implement the NIH Data Management and Sharing Policy on January 25, 2023, the NIH has released Informed Consent for...Read the article
Free Live Webinar – A 21st Century Approach to ADA Compliance: Equity and Access
In this webinar, we will explore strategies to address the inequities that exist within research practices to ensure the ethical inclusion of subjects in clinical trials.Read the article