Introducing Clinical Research Base Subscription

CITI Program is proud to announce Clinical Research base subscription offering – a clinical research training solution for organizations.

This organizational base subscription includes six series in its base package:

Biomedical Principal Investigator
Clinical Research Coordinator - Comprehensive
Clinical Research:  An Introduction
FDA Inspections:  From Site Preparation to Response
Good Clinical Practice (GCP)
Good Manufacturing Practices (GMP)

Core Training

Our trusted Good Clinical Practice (GCP) series features mutually-recognized basic and refresher courses with a focus on ICH E6 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 specific 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 the quality management system, 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.

Choosing the Clinical Research 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 on an ongoing basis to make sure it aligns with the most current thinking.

For organizations, you can add the Clinical Research base subscription to your existing subscription or begin your organizational subscription with this clinical research focused training.

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FAQs

What is the Clinical Research Base Subscription?
The Clinical Research subscription is a collection of six (6) courses covering topics in clinical research for one subscription price.

What courses are included in the Clinical Research Base Subscription?
The Clinical Research 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 Clinical Research 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 Clinical Research 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 Foundations 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 of courses, the Clinical Research subscription provides organizations with several clinical research course options to train their staff in more than one area.

Are CE/CME credits and units available?
Each course offers documentation of completion through certificates and completion reports that are easily shareable.  Some courses offer the ability to purchase CE/CME credits that can be used for professional re-certifications and education.

Can my organization subscribe to both the Research Foundations and Clinical Research Base Subscription?

Yes, an organization can have both a Research Foundations and Clinical Research 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?

Visit https://about.citiprogram.org/new-subscriptions/ for more information and contact CITI Program Sales to subscribe. 
Phone 888-529-5929; (Outside of U.S.) 305-907-3100.