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CITI Program is proud to announce the Research II base subscription option, a clinical research training solution for organizations. This subscription provides a range of training options and includes core training, topic-focused, and role-based courses for clinical researchers. It also covers special topics not covered in our Research I base subscription.
- Good Clinical Practice (GCP)
- Clinical Research: An Introduction
- FDA Inspections: From Site Preparation to Response
- Good Manufacturing Practices (GMP)
- Biomedical Principal Investigator (PI)
- Clinical Research Coordinator (CRC)
Each of these content areas are carefully crafted to fit your organization’s clinical research training needs.
Core Training
Our trusted Good Clinical Practice (GCP) series features mutually recognized basic and refresher courses with a focus on ICH E6(R2) guidelines, FDA regulations, drug and medical device investigations, and social and behavioral research. The courses include in-depth discussions on informed consent, sponsor and investigator responsibilities, detection and reporting of adverse events, and auditing and monitoring expectations.
The Clinical Research: An Introduction course provides the basic concepts of what clinical research is, how it is carried out and by whom, and its underlying ethical and regulatory framework. It discusses the core principles of GCP and explores specific issues in clinical research, including protocol design, critical regulations and oversight bodies, common types of clinical trials, regulatory compliance, and clinical research billing.
Topic-Focused Training
The FDA Inspections: From Site Preparation to Response course explains the inspection process and terminology, and provides strategies to prepare for an inspection, including reviewing of regulatory guidance and manuals, actively preparing the study team, and performing mock inspections. It examines the importance of the Form FDA 482, how to coordinate and communicate during an inspection, and next steps and strategies for responding to a Form FDA 483. The course also discusses how to create a CAPA plan to address findings.
The Good Manufacturing Practices (GMP) course provides an introduction to GMP for pharmaceuticals and the current U.S. FDA regulations. It reviews a brief history of GMP regulations and discusses the regulatory requirements for quality management systems, equipment, batch records, validation, packaging, labeling, holding, distribution, and audits.
Role-Based Training
Biomedical Principal Investigator (PI) course focuses on key topics essential to the biomedical investigator’s role and responsibilities in conducting a clinical investigation of a product regulated by the U.S. Food and Drug Administration (FDA). This role-based course covers supervision, delegation, management, reports, and communication for investigators.
The Comprehensive CRC series features two courses: Clinical Research Coordinator Foundations and Clinical Research Coordinator Advanced.
- The CRC Foundations course provides training tailored to the CRC’s fundamental role in the conduct of clinical trials. It is designed for new CRCs and can be used by organizations as onboarding training. It may also be useful to those pursuing a career in clinical research.
- The CRC Advanced course provides second-level training for CRCs (those with two or more years’ experience). It covers advanced topics related to the CRC’s critical role in the conduct of clinical trials. It complements the foundational course and may be used for professional development and/or as a refresher course, or as an alternative to certification.
Add-On Courses
The Protocol Registration and Results Disclosure in ClinicalTrials.gov is a video-enhanced guide to compliance with the FDAAA Final Rule and NIH policy on clinical trial disclosure in 42 CFR 11. This innovative course guides learners through critical parts of the regulations and provides a step-by-step guide to data entry, thus helping organizations avoid the risk of significant civil monetary penalties or loss of NIH grant funding.
The Clinical Trial Billing Compliance (CTBC) course focuses on developing the knowledge and skills necessary to maintain compliance and best practices associated with clinical research billing.
Choosing the Research II Base Subscription
Our courses are developed by experts and rigorously peer reviewed to incorporate various perspectives and ensure accuracy, completeness, and overall quality. In addition, we continually review our content to make sure it aligns with the most current thinking.
FAQs
What is the Research II base subscription?
The Research II base subscription is a collection of six courses covering topics in clinical research for one subscription price. Two add-on courses are available for an additional fee.
What courses are included in the Research II base subscription?
This base subscription includes six content areas, featuring our overview course entitled Clinical Research: An Introduction, our trusted Good Clinical Practice (GCP) series with its mutually recognized courses, our topic-focused FDA Inspections: From Site Preparation to Response course and Good Manufacturing Practices (GMP) course, and our role-based courses for clinical research professionals including Biomedical Principal Investigator (PI) and Comprehensive CRC.
What organizations should subscribe to Research II base subscription?
New or existing organizations that are looking to onboard new clinical research staff or provide current employees with professional development opportunities.
Who is the target audience for the courses?
The courses are designed for new and experienced clinical research professionals looking to enter into a new field or advance within their current field.
Specific audiences include undergraduate and graduate studies, university faculty and postdocs, research compliance officers, new clinical investigators, research nurses, clinical research coordinators, research administrators, clinical data managers, and clinical billing professionals.
What are the advantages to organizations of purchasing the Research II base subscription?
The base subscription provides a single package comprised of clinical research training for your organization. This organizational subscription can be instead of the Research I subscription or in addition to it, and it can also be combined with a make-your-own subscription offering as well.
Courses provide topic- and role-specific, peer-reviewed training developed by experts. Along with CITI Program’s advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, the subscription is an excellent choice for organizations looking to train their new and existing staff. As a collection courses, the Research II subscription provides organizations with several clinical research course options to train their staff in more than one area.
Are there other courses available as add-ons for Research II base subscription?
Yes. We recommend two courses that can be purchased as add-ons to the Research II subscription: Clinical Trial Billing Compliance (CTBC) and Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov. However, most of our content can be added on to your organization’s subscription. Review our complete content catalog.
Are CE/CME credits and units available?
Several of the courses in this base subscription offer the ability to purchase CE/CME credits that can be used for professional re-certifications and education. Each Research II course offers documentation of completion through certificates and completion reports that are easily shareable.
How does the Research I differ from the Research II base subscription?
Research I base subscription contains a different set of six courses. Research I is designed for general research training needs, whereas Research II provides clinical research focused courses. Research II is designed to supplement or be an alternative to Research I.
Can my organization subscribe to both Research I and Research II subscriptions?
Yes. An organization can have both a Research I and a Research II base subscription to have access to both sets of courses. Alternatively, an organization can add on individual courses to any base subscription or an organization may create a “Make Your Own” subscription with six courses of its choosing. CITI Program offers different subscription options to best meet your organization’s training requirements.
Where can I go for more information and to subscribe?
