what is refresher course citi

Refresher courses provide retraining for individuals who have already completed a basic course. CITI Program offers a variety of refresher courses so learners can meet retraining requirements with fresh content.

Full Answer

How do I add a refresher course to my Citi program?

GCP ICH Refresher reinforces the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) course. This course meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

What is a refresher course?

Subjects Training Refresher Course to meet training recertification requirements imposed by some funding agencies. This document provides guidance related to enrollment and completion of this online course. In this document: Enrolling in the Refresher Training Completing the Refresher Training Records Additional Information

Does Citi program’s HSR Training fulfill the human subjects research training requirements?

1. CITI Training – Add a Refresher Course. 1. Go to the CITI Program website (www.citiprogram.org). 2. Log onto the CITI website using your CITI user name and password. - If this is your first time completing CITI training, you will need to setup a username and password. First, click the “Register” button on the login screen under “Create a New Account.”.

Who uses Citi Program GCP training?

This refresher course provides retraining on the core RCR topics and discusses the core norms, principles, regulations, and rules governing the practice of research. View Series Page for FAQs. Language Availability: English . Suggested Audiences: Faculty, Postdoctoral Researchers, Principal Investigators, Staff, Students

How do I use the Citi refresher course?

How do I take the CITI refresher courses? Log in to the CITI webpage. Once you log in you will see the link to the Student/Faculty Basic course in human subjects training. Once you proceed at that link CITI will automatically guide you through the required CITI refresher modules.

How long does the Citi refresher course take?

approximately 2 hoursHow long will it take to complete the course? Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hrs in the Basic Course site and approximately 1.5 hours if your site requires additional modules. The Refresher Training will take approximately 2 hours.

Does CITI training expire?

CITI training courses expire every 3 years and CITI will send e-mail reminders 90 days before your courses expire. The refresher courses are automatically added to your curriculum, and will be visible, when you log into your account.

Can you cheat on CITI training?

Not sharing course-related quiz questions or answers on any website, via email, photocopying, or any other means. Such sharing is considered cheating, regardless of intent. Not misrepresenting your identity or the identity of any other learner with respect to quiz completions or other learning activities.Mar 1, 2021

Should I put Citi training on resume?

A CITI certification should be included in the certifications section on a resume. Include the date you became certified and do not include expired certifications. For those who specifically work in the research industry, this information may be placed in the summary section.Aug 28, 2021

Can you retake Citi quizzes?

Yes, the test modules may be taken as many times as needed. When you complete the test and do not pass, you can select Re-enter. This will allow you to select and retake any of the individual modules.Apr 22, 2015

Why is Citi training important?

The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners.

Is Citi training free?

Learn how to take courses required by your organization. You can register now to take CITI Program content assigned to you by your organization for no charge. If you need training not provided by your organization, you can register as an independent learner and purchase the content required.

What do you learn in Citi training?

The program involves the certification of faculty and students in general research and ethics for working with human subjects. The CITI program is a self-paced course that covers the historical development of human subject protections, as well as current information on regulatory and ethical issues.

Is the CITI Program timed?

The time required to complete each of the basic modules varies between 10 to 30 minutes. The total time is estimated to be 2-3 hours. The course does not have to be completed in one sitting and you can enter the course at any time.

Does Citi track?

We collect information about you in a range of forms, including personal data that includes information which, either alone or in combination with other information we hold about you, identifies you as an individual. This includes, for example, your name, postal address, email address(es), and telephone number(s).

When a patient enters a clinical facility they must?

When a patient enters a clinical facility, they must inevitably surrender control of their information for a broad range of uses and disclosures.

About this Course

This refresher course provides retraining on the core RCR topics and discusses the core norms, principles, regulations, and rules governing the practice of research.

Course Content

Describes the important issues relating to publishing research results and working with authors. It also discusses the potential pitfalls and errors that can lead to research misconduct and authorship disputes, as well as strategies for avoiding and resolving authorship disputes.

SBE Refresher 1 – History and Ethical Principles

Describes principles of respect for persons, beneficence, and justice. Identifies the federal regulations that derive from the Belmont principles. Summarizes the key concepts from the module History and Ethical Principles – SBE.

SBE Refresher 1 – Federal Regulations for Protecting Research Subjects

Highlights the topic of IRB regulatory review criteria from the module The Regulations – SBE. Identifies what IRBs must consider to approve research pursuant to 45 CFR 46.

SBE Refresher 1 – Defining Research with Human Subjects

Explores the regulatory definitions of "research" and "human subject." Discusses the concept of “systematic investigation.” Based on the basic module Defining Research with Human Subjects – SBE.

SBE Refresher 1 – Informed Consent

Provides refresher training on informed consent, including the general requirements of informed consent and the additional requirements of informed consent that may be necessary depending on the research. Highlights key concepts from the module Informed Consent – SBE.

SBE Refresher 1 – Assessing Risk

Reviews ways to minimize the potential of breach of confidentiality. Discusses breaches of confidentiality focusing on minimizing the potential for disclosure. The foundation of this refresher module is Assessing Risk – SBE.

SBE Refresher 1 – Privacy and Confidentiality

Discusses key terms from the module Privacy and Confidentiality – SBE, including “privacy” and “confidentiality” and ways to protect subjects.

SBE Refresher 1 – Research with Prisoners

Defines “prisoner” and identifies research that may be conducted with prisoners as subjects, pursuant to 45 CFR 46, Subpart C, and provides examples. Summarizes basic module Research with Prisoners – SBE.

Biomed Refresher 1 – History and Ethical Principles

Covers the Belmont Report’s ethical principles including respect for persons, beneficence, and justice as they relate to human subjects research. Based on History and Ethical Principles module.

Biomed Refresher 1 – Regulations and Process

Defines “research” and “human subject,” identifies different types of exempt research, and discusses the process for expedited review. Also distinguishes populations where exempt review is not appropriate. Provides refresher training for the basic module Basic Institutional Review Board (IRB) Regulations and Review Process.

Biomed Refresher 1 – Informed Consent

Reviews key concepts from the basic module Informed Consent.

Biomed Refresher 1 – SBR Methodologies in Biomedical Research

Highlights essential topics from the basic module Social and Behavioral Research (SBR) for Biomedical Researchers, including identifying the risks of harm to subjects associated with SBR and presenting some reasons why SBR may be perceived as low risk.

Biomed Refresher 1 – Records-Based Research

Identifies what levels of regulatory authority apply to research with records, describes the steps to ensure the protection of privacy and confidentiality when using existing records for research, and discusses the IRB’s role regarding informed consent (and waiver of consent) to collect data from existing records.

Biomed Refresher 1 – Genetics Research

Describes the difference between genetic privacy and confidentiality, lists the information that should be disclosed to subjects during the consent process associated with genetics research, and describes some of the risks of harm associated with genetic research.

Biomed Refresher 1 – Research Involving Prisoners

Describes why prisoners need special protections as subjects, identifies the types of research permitted with prisoners, and explains what to do if a subject becomes a prisoner during a research study. Highlights topics covered in basic module Vulnerable Subjects – Prisoners.

New Course – GCP FDA Refresher (April 2016)

A new refresher course entitled GCP FDA Refresher is now available. This refresher is meant to reinforce the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course.

Modules

GCP Refresher – International Conference on Harmonisation (ICH): GCP Requirements

GCP Device Refresher (April 2016)

A new refresher course entitled GCP Device Refresher is now available. This course is meant to reinforce the importance of concepts covered in the basic level GCP for Clinical Investigations of Devices course.

Who should take human subjects research training?

Basic HSR courses are suitable for all persons involved in research studies involving human subjects (for example, researchers and staff), or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs) and other members of organizational communities where research with human subjects occurs..

How long does it take to complete an HSR course?

HSR courses are comprised of modules that include detailed content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace. Each module varies in length, and learners may require different amounts of time to complete the module based on their familiarity and knowledge of the topic.

What different courses are offered in HSR?

This series contains Basic and Refresher courses that are structured into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). These tracks contain different levels of review-- Compressive and Foundations.

How frequently should learners take HSR training?

There is no uniform standard regarding how frequently HSR training should occur. However, most organizations select a three-year cycle of retraining.

Does HSR fulfill the human subjects training requirement?

Yes, CITI Program’s HSR training fulfills the human subjects research training requirements if the learner completes the basic modules for either the Biomed or SBE Comprehensive or Foundations courses.

As an administrator setting up my organization, how should I select HSR modules for my learner groups?

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs. You can also choose to use our recommended learner groups.

What topics does HSR cover?

HSR covers the historical development of human subject protections, as well as current regulatory information and ethical issues.

Is GCP training the same as human subjects protection training?

No. GCP training is a separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

Does CITI Program offer GCP training that is compliant with the NIH policy?

The National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP.

Who should take GCP training?

GCP content is suitable for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.

How do I know which GCP course I should take?

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.

How long does it take to complete a GCP course?

GCP courses vary on the number of modules they contain. Modules consist of detailed content, images, supplemental materials (such as case studies), and a quiz. Learners may complete the modules at their own pace.

Are GCP courses mutually recognized by TransCelerate BioPharma as meeting the minimum GCP ICH criteria?

Yes, five of CITI Program's GCP courses are mutually recognized. See the individual course pages for more information on TransCelerate mutual recognition, including requirements (such as module requirements) for organizations and learners to utilize the mutually recognized courses.

How do I know if my GCP course will be mutually recognized by TransCelerate BioPharma and study monitors?

Learners who fulfill a GCP course’s requirements (complete all the required modules after the effective date) will see a statement in the Description field on their Completion Report’s “Transcript Report” (part 2 of a Completion Report) or on their Certificate.

What is protocol builder?

Protocol Builder is an online protocol writing and collaboration platform that also speed up your pre-review turnaround times. BIC Study Foundation is a resource for those who want to take CITI Program courses in Korean. They are a certified training provider by the Korean FDA/MAFRA for HRPP and ACU Programs.

Is Albert Einstein College of Medicine accredited?

Albert Einstein College of Medicine-Montefiore Medical Center (Einstein) is accredited by the Joint Accreditation for Interprofessional Continuing Education to provide continuing education activities for healthcare professionals.