New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements

(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials.

The three courses and webinars address critical regulatory requirements:

  • Transitioning research to the Revised Common Rule
  • Protocol registration and disclosure on ClinicalTrials.gov
  • The role of principal investigators in meeting regulatory requirements

Transitioning Research to the Revised Common Rule: The What, How, and Why, a webinar that outlines considerations and challenges for transitioning pre-existing research to the revised Common Rule, as well as required documentation and tips for IRB review, is offered to both institutions and individual learners.

Designed for research professionals, including investigators, institutional review boards and research staff, the webinar reviews pre-2018 and 2018 versions of the Common Rule, including factors an organization may want to consider when deciding whether to transition a pre-existing study (or studies) to comply with the revised Common Rule, and strategies for the management and communication of transition decisions.

The webinar is presented by Karen Christianson, RN, BSN, a principal with HRP Consulting Group.

Recently published research demonstrates that many research institutions are not prepared to meet current requirements for registering and reporting clinical trials. A new course addresses this gap.

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov, an innovative video-enhanced course, guides learners through critical parts of the regulations and provides a step-by-step guide to data entry. This course can help organizations/investigators clearly understand protocol registration requirements to avoid the risk of significant civil monetary penalties or loss of NIH grant funding due to non-compliance with protocol registration and results reporting.

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). This role-based course covers supervision, delegation, management, reports, and communication for investigators.

These courses, along with dozens of others available at CITIprogram.org, train investigators and research professionals to understand and meet research ethics standards and compliance requirements.

About CITI Program

The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, is dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.

 

Survey Results

Last year we asked research staff and managers to tell us about their staff training needs. We want to thank those who took the time to complete the questionnaire. The results are in and here is what we learned.

  • The majority of those who responded to the survey either have limited or no funding for training and education activities.
  • Over one-third of respondents said online courses, including webinars, were made available to research support staff. Additionally, respondents said online courses and webinars either are or would be the most useful to staff.
  • Frequency of training is variable, with most institutions reporting either annual or quarterly.
  • Content needs also varied, but 45% of respondents said regulatory training, such as good clinical practices, regulations and IRB management, was their biggest need. Respondents also said they needed training in strategies to effectively execute clinical research studies.

Training for research staff is critical to ensure awareness of ethics involved in human subjects research, and to stay abreast of regulatory and compliance issues related to clinical research. This is true not only for onboarding new clinical research staff, but also for continuing education and professional development of experienced professionals.

Unfortunately, with the majority of respondents suggesting they do not receive adequate training, institutions may be missing an opportunity to optimize their workforce, and may be putting institutions at risk of non-compliance when their staff are not properly trained.

Many research professionals, from research coordinators to new investigators, may be eligible to take CITI Program’s online courses through their institutions’ subscription. Check with your research office to find out if they are organizational subscribers.

Resources

Learn more about organizational subscriptions: https://about.citiprogram.org/en/organizational-subscriptions

Learn more about online training for clinical research coordinators through CITI. We offer both basic and advanced courses. https://about.citiprogram.org/en/series/clinical-research-coordinator-crc/