Review CITI Program’s latest additions and updates to the ever-evolving course catalog.

New Revised Common Rule Course  – Human Subjects Research (HSR)

Revised Common Rule provides a detailed review of the changes to the Common Rule, including a focused overview and topic-specific modules. Organizations can easily manage training on the revised Common Rule by setting up new learner groups and utilizing administrator reporting tools.

Topics covered:

  • Overview of the Final Rule Revisions
  • New and Revised Definitions
  • Informed Consent – Changes and Additions to Consent Processes
  • Informed Consent – Changes to the Documentation of Consent
  • Understanding Broad Consent
  • Secondary Research with Identifiable Information and Biospecimens
  • Effect of Revised Common Rule on Research Roles
  • Updates to Exemption Categories
  • Limited IRB Review
  • Updates to Expedited Review Procedures

Organizational Subscription Price: $300 per year/per site

Independent Learner Price: $129 per person

Demo Revised Common Rule | View Course Page | Add Course

New GCP SBR Advanced Refresher  – Good Clinical Practice (GCP)

GCP SBR Advanced Refresher reinforces the importance of concepts covered in the basic level GCP – Social and Behavioral Research Best Practices for Clinical Research course. This second-level course goes in-depth on more advanced GCP concepts, expands upon the breadth of the investigator’s responsibilities, and explores topics relevant to social sciences research and behavioral trials not traditionally covered in GCP courses.

Topics covered:

  • When a Social and Behavioral Research Study May be Considered a Clinical Trial
  • Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research
  • Investigator’s Role and Responsibilities in Behavioral Interventions and Social Science Research
  • Informed Consent in Behavioral Interventions and Social Science Research
  • Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research
  • Methods and Risks in Behavioral Interventions and Social Science Research
  • Social Media in Behavioral Interventions and Social Science Research
  • In-Depth Review of ICH E6 and TransCelerate Minimum Requirements

Organizational Subscription Price: Included in organizational subscription

Independent Learner Price: $129 per person

Demo GCP SBR Advanced Refresher | View Course Page | Add Course (no additional fee)

New Research Study Design

Research Study Design provides learners with an understanding of how to improve study design, collect and analyze data, and promote reproducible research.

Topics covered:

  • Introduction to Scientific Research
  • Observational Research
  • Interventional Research
  • Quantitative Research (Statistical Reasoning and Hypothesis Testing) – Part 1
  • Quantitative Research (Statistical Reasoning and Hypothesis Testing) – Part 2
  • Survey Research: Designing the Instrument
  • Survey Research: Conducting the Research
  • Qualitative Research Methods
  • Mixed Methods Research
  • Data Management
  • Reproducibility of Research Results

Organizational Subscription Price: Ask about special bundle pricing

Independent Learner Price: $300 per person

Demo Research Study Design | View Course Page |  Add Course

Updated Working with the IACUC – Animal Care and Use (ACU)

Working with the IACUC has been significantly updated to improve the course’s content, structure, alignment with current regulatory guidelines, and delivery. The course still provides the same necessary basic training on the protection of animal subjects used in research, but now with nine comprehensive, concise modules and two additional modules of interest.

Subscribing organizations may add and/or switch to the updated course starting today. It is available for no additional fee. However, there are a few key things to understand and consider if your organization utilizes the existing course. Review key considerations.

Demo Working with the IACUC | View Course Page | Add Course (no additional fee)

Updated Belmont Report and Its Principles module – Human Subjects Research (HSR)

Effective 16 April 2018, CITI Program brought back the module entitled “Belmont Report and Its Principles.” An earlier iteration of this module was retired 17 August 2017, because discussion of the application of Belmont’s principles to research is covered in other core modules. However, we have decided to restore this module to facilitate learner access of the full reading of the Belmont Report. The new version of this module will present the learners with a link to access the report and require them to read it in its entirety.

If your organization previously utilized this module, we will restore it automatically to your gradebooks.

Demo Belmont Report and Its Principles | Contact Us | Add Module (no additional fee)

Name Change: Fundamentals of Biostatistics is now Essentials of Statistical Analysis

Fundamentals of Biostatistics has been renamed to more accurately reflect the course content and is now Essentials of Statistical Analysis. The course itself has not been altered and progress towards completion will not be affected.

Return to May 2018 Newsletter