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Required Human Research Training

 

I. Human Research Ethics Training


CITI (Collaborative Institutional Training Initiative) Course Information

 

Link to the CITI Online Course -  http://www.citiprogram.org/

 

Review the UMCIRB standard operating practice related to required ethics training by clicking on the following link: Requirements for Human Research Protections Training

 

Who is required to complete the CITI training?

All key research personnel must complete the required education. Key research personnel include principal investigators, sub-investigators, research coordinators, and any other research team members that have contact with research participants, and their research data or private information. 

 

What should I expect if I have never visited/used the CITI site before?

In order to access the CITI training modules you will be required to register as a user with the CITI site. When you register you will be asked to provide your name and contact information. Please note, the CITI site is NOT administered by ECU therefore is not linked to ePIRATE in any way. You will not be using your pirateID to log into the CITI site. During the registration process you will be asked to provide the username and password of your choice. Please keep this information handy as you will need it again when you take the refresher course in three years. When you register you will be asked to select an institution with which you are affiliated, please select East Carolina University. 

 

Which CITI modules should I complete?

The modules are grouped by categories of research. For UMCIRB purposes, you only need to complete one of the two groups of modules listed below. You should select the group that best fits the type of research you normally conduct. If in doubt, contact ORIC for guidance. 

 

  • Group 1. All Biomedical Investigators and Key Personnel: Medical, physiological or pharmacological studies that typically involve direct contact with participants. Includes, but is not limited to, research with drugs, devices or other interventions.
  • Group 2. Social/Behavioral Research Investigators and Key Personnel: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with participants. Does NOT include drug or device studies.

 

Why am I required to take this training?

Education is vital to conducting ethical research studies. The UMCIRB recognizes that education is an ongoing process, not a one-time effort. Completing the CITI modules, reading the Belmont Report, 45CFR46, and other pertinent regulations provides a solid foundation for which continuing education can be accomplished. ECU requires this education based on Health and Human Services (HHS) recommendations. 

 

When do I need to complete this training?

The required training modules must be completed by all research team members prior to the UMCIRB granting approval for any research study, regardless of the level of risk or category of review. The training is good for three years. After three years, the modules must be updated utilizing the refresher course available through CITI. The CITI site will send a notification approximately 90 days prior to the expiration of your training period. The notification will be sent to the email address you provide when you register for the training. 

 

How long will it take to complete the modules?

This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete. Researchers familiar with these topics may require three hours or less to complete all of the required modules. You do not have to complete all the modules at once. CITI is designed for you to work at your own pace, and allows you to exit and return at a later date to where you left off. 

 

What is considered a passing score?

The required passing score is 70%. The score is based on the overall score of the quizzes at the end of each of the required modules. You may check your grade by selecting the grade book link on the welcome page or at the end of the course. If you do not pass, you can return to the modules and re-take the quizzes. 

 

What if I have completed CITI training at another institution?

If you are a new faculty, staff or student at ECU and have completed the same CITI training modules at another institution, you may long into the CITI site with the CITI username and password you created when you registered to use CITI and you may choose to "affiliate with another institution". When you do this, select East Carolina University. 

 

What if I have completed human research ethics training through a different site such as the NIH?

Currently UMCIRB recognizes only the CITI training described above. You will need to log into the CITI site, register as a new user and complete the training modules required by ECU. 

 

How do I verify my training to the UMCIRB?

In order to verify successful completion of the required CITI training you must log the completion date in your ePIRATE profile. Click on the following link for instructions. How to Add Your IRB Training Completion Date to Your ePIRATE Profile (PPT). Once a person's CITI training data is logged in their ePIRATE profile it will be automatically populated next to their name in any new study submission received by the IRB. Do not forget to  update your ePIRATE profile when you complete the required refresher course every three years. 

 

The CITI program site and ePIRATE ARE NOT connected in any way. The CITI program is a software platform for web-based training purposes and is not administered by ECU. ePIRATE is a software platform administered by ECU for electronic IRB submission, review and approval. 

 

Why am I having trouble viewing the CITI site?

To make full use of the features of the CITI site, and to do so securely, use a current browser version when accessing the CITI Program. The vast majority of browsers made available within the last 3-4 years will support all CITI Program features. Older versions may not, as they are often less secure and provide less functionality. 

 

Is there a fee?

Individual users who are taking the training required by the UMCIRB to conduct human research are not assessed a fee for the CITI training. 

 

What if I have questions?

You may contact ORIC at 252-744-2914 or contact us via email at UMCIRB@ecu.edu

 

 

II. Good Clinical Practice (GCP) Training for NIH-Funded Clinical Trials

 

Good Clinical Practice (GCP) is the international ethical and scientific standard expected in the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial participants are protected.

 

NIH has issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete Good Clinical Practice (GCP) training by January 1, 2017. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to trial design, conduct, and reporting. GCP training is in addition to, and different from, Human Subject Protection training, which is required by the UMCIRB. Some specifics about the policy:

 

  • This Policy applies to investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials.
  • For new NIH-funded clinical trials, you must provide documentation of training completion as part of the Just-in-Time process. It is not yet clear how NIH will implement this requirement for ongoing awards.

 

GCP Training for Clinical Trials Involving Drugs, Biologics and Devices

 

Link to the CITI Online Course - http://www.citiprogram.org/

 

GCP Training for Social Behavioral Research

 

Link to the Society of Behavioral Medicine (SBM) Online Course - http://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course

 

Who is required to complete the GCP CITI training?

All key research personnel involved in NIH-funded clinical trials are expected to document the completion of GCP training. Key research personnel include principal investigators, sub-investigators, research coordinators, and any other research team members who are involved in the design, conduct, or reporting of clinical trials involving human participants. 

 

Which GCP modules should I complete?

Select the following course applicable to the research in which you are involved to satisfy the requirement for GCP training:

 

  • CITI Program - GCP for Clinical Trials with Investigational Drugs, Biologics and Devices - Basic Course - for NIH-funded research involving drugs, biologics and/or devices.
  • SBM eLearning Course - GCP for Social Behavioral Research - GCP training that is more relevant to the Social and Behavioral Researcher PI and other key personnel involved in all new and ongoing clinical trials.

If you are involved in biological, drug or device research as well as social and behavioral research you are required to complete the CITI GCP training. If you have taken the CITI GCP training for biologics/drugs and devices you do not have to take the additional social and behavioral GCP training if you are involved in social/behavioral research. 

 

Why am I required to complete this training?

NIH has issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete Good Clinical Practice (GCP) training by January 1, 2017. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to trial design, conduct, and reporting. GCP training is in addition to, and different from, Human Subject Protection training, which is required by the UMCIRB. 

 

When do I need to complete this training?

For new NIH-funded clinical trials, you must provide documentation of training completion as part of the Just-in-Time process. It is not yet clear how NIH will implement this requirement for ongoing awards. The new NIH policy requires GCP training be refreshed every three years in order to remain current with regulations, standards and guidelines.

 

How long will it take to complete the modules?

This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete. Researchers familiar with these topics may require three hours or less to complete all of the required modules. You do not have to complete all the modules at once. Both the CITI and SMB training sites are designed for you to work at your own pace, and allow you to exit and return at a later date to where you left off. 

 

What is considered a passing score?

The required passing score if you are taking the CITI modules is 70%. The score is based on the overall score from all the required modules. You may check your grade by selecting the grade book link on the welcome page or at the end of the course. If you do not pass, you can return to the modules and re-take the quizzes. 

 

The required passing score if you are taking the SBM modules is 100% (this has been set by the Society for Behavioral Medicine). If you do not pass the quizzes with a score of 100% you will be given the option to retake the quizzes until you score 100%. 

 

What if I have completed GCP CITI training at another institution?

If you are a new faculty, staff or student at ECU and have completed the same GCP CITI training modules at another institution within the last three years, you may log into the CITI site with the CITI username and password you created when you registered to use CITI and you may choose to "affiliate with another institution". When you do this, select East Carolina University. If you have completed the SBM modules within the last three years at another institution you should upload a copy of the certification of completion in your ePIRATE profile. 

 

What if I have completed GCP training through a different site such as the NIH?

If you have successfully completed GCP training through another site within the past three years we will accept this training. When you update your ePIRATE profile with your GCP training information please upload a copy of the certificate of completion. 

 

How do I verify my GCP training to the UMCIRB?

In order to verify successful completion of the required GCP training you must log the completion date in your ePIRATE profile. Click on the following link for instructions How to Add Your IRB Training Completion Date to Your ePIRATE Profile (PPT). Once a person's CITI or SBM training date is logged in their ePIRATE profile it will be automatically populated in any new study submission received by the UMCIRB. Do not forget to update your ePIRATE profile when you complete the required refresher course every three years. 

 

Why am I having trouble viewing the CITI site?

To make full use of the features of the CITI site, and to do so securely, use a current browser version when accessing CITI Program. The vast majority of browsers made available within the last 3-4 years will support all CITI Program features. Older versions may not, as they are often less secure and provide less functionality. 

 

Is there a fee?

Individual users who are taking the CITI or SBM GCP training as required by NIH are not assessed a fee for the training. 

 

What if I have questions?

You may contact ORIC at 252-744-2914 or contact us via email at UMCIRB@ecu.edu.

 

Other Pertinent Training and Education Links