New and Updated Content (March-June 2019)

Review CITI Program’s new and updated content. Content is listed in order of release.


New Webinar: The Challenge of Medicare Advantage Plans and Local Coverage Determinations

Medicare Advantage Plans have a unique set of challenges within the reimbursement of drug and investigational device exemption (IDE) studies. The Challenge of Medicare Advantage Plans and Local Coverage Determinations discusses ways to navigate these challenges and ensure successful reimbursement in these kinds of trials.

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New Course: Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov serves as a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial registration and summary results submission in ClinicalTrials.gov. 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.

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New Course: Semiannual Evaluations In Depth

Semiannual Evaluations In Depth promotes continuing education for IACUC members and administrators by providing additional knowledge and expertise regarding the conduct of semiannual evaluations. Subscribe today to maintain a high-quality animal care and use program at your organization.

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New Webinar: Transitioning Research to the Revised Common Rule: The What, How, and Why

Transitioning Research to the Revised Common Rule: The What, How, and Why informs learners about considerations and challenges for transitioning pre-existing research to the revised Common Rule, as well as required documentation and tips for IRB review. It also serves as a practical complement to the Revised Common Rule course.

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New Course: Biomedical PI

Biomedical PI 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). Use it to train your new investigators or as refresher training for your more experienced investigators.

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New Course: EC Refresher - Export Compliance (EC)

The EC Refresher provides a basic review of export compliance. It discusses export compliance issues and concepts that can be encountered in research activities in international and foreign waters, life sciences (biological) research, and common day-to-day business operations. This course is available as part of your subscription to EC.

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New Module: Hot Topics in Clinical Research - Good Clinical Practice (GCP)

Hot Topics in Clinical Research brings you the most recent research news affecting clinical trials, covering various regulatory issues, new policies, updated requirements, and more. The module is revised and updated throughout the year and designed to be a tool to come back to regularly to see all recent updates and current issues. This module is available for no additional fee and can be added at any time to your GCP subscription.

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New Module: Overview of ICH GCP E6(R2) Revisions - Good Clinical Practice (GCP)

Overview of ICH GCP E6(R2) Revisions explores and analyzes the changes in this international standard of good clinical practice. This module provides a simple and complete review of ICH E6(R2) for those already familiar with ICH E6. This module is available for no additional fee and can be added at any time to your GCP subscription.

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New Module: Financial Management of Clinical Trials - Clinical Research Coordinator (CRC)

Financial Management of Clinical Trials delivers an overview of budget formulation and cost identification, discusses subject remuneration and reimbursement, reviews complex billing issues (including Medicare), identifies how to avoid fraud and abuse in billing, and concludes with the importance of budget reconciliation. This module is available as part of your subscription to CRC Advanced.

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