The CWRU CREC Program stands for the Case Western Reserve University's Continuing Research Education Credit (CREC) Program, developed to provide documented training in the protection of human subjects in research that is conducted at University Hospitals Cleveland Medical Center, The MetroHealth System, and Case Western Reserve University. In some instances, researchers from the Louis Stokes Cleveland VA Medical Center (LSCVAMC) and The Cleveland Clinic may also participate in the CREC Program.
The CREC Program was created to provide documented training for all Responsible Investigators, regardless of sponsorship, as well as those Key Personnel listed on NIH grants. Investigators must meet the initial core CREC requirements before the IRB will grant approval, and must obtain a specified number of credits (12) over a specified time (3 years) to retain CREC certification.
The CWRU Institutional Review Board (IRB) Advisory Committee determines the guidelines and criteria for the CREC Program. The CREC Program is in compliance with NIH human subjects research educational requirements. For further information on the CREC Program and a link to the online training program, please visit the CREC Program website.
You are required to be CREC certified if any of the following apply to you:
- You are involved in human subjects research and are listed as Key Personnel on an NIH grant
- You are listed as the Responsible Investigator, Co-Investigator, or Key Personnel (including graduate and undergraduate student researchers) on a CWRU SBER IRB protocol
- You are obtaining consent under a University Hospitals of Cleveland or a MetroHealth System IRB protocol.
- Researchers who wish to participate in the CREC program, but are not officially required to do so may use the program at no charge.
Cleveland Clinic researchers listed as Key Personnel on NIH grants administered by CWRU may meet their educational requirement through The Cleveland Clinic's educational program.
LSCVAMC researchers do not have to participate in CREC if they do not meet any of the above criteria. They are, however, required to meet VA educational requirements.
Cleveland Clinic and LSCVAMC researchers can use valid, up-to-date certifications from their respective institutions to obtain a certificate in the CWRU CREC Program. This option is only available to researchers at these two institutions.
A Responsible Investigator ("RI") is usually a CWRU faculty member who is current in his/her certification for training in the protection of human subjects. If an individual is not a faculty member but is certified as someone, "with whom the University has or intends to have an ongoing contractual relationship," then he/she must have an RI Certification Form on file with the CWRU SBER IRB.
According to the University Policy on the Involvement of Human Participants in Research, "A faculty member assigning research projects involving human subjects must take an active role in assuring that the subjects of student research are adequately protected. The University expects that advisors will take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research and assisting in the preparation of IRB applications. After protocol approval the advisor should meet regularly with the student in order to review their work and progress. While a student serves as the primary researcher protocol, the faculty advisor is ultimately responsible for the protection of human subjects. A faculty member's signature on the application indicates their willingness to comply with all administrative and federal regulations."
To comply with this policy, the faculty member who is acting as the Responsible Investigator is required to educate and mentor the research team, but is also responsible for maintaining research records as required by University Policy and Federal Regulations.
New faculty members who have documented training in the protection of human subjects in research from their former institutions have one year from their hire dates in order to obtain initial core CREC certification. New faculty members without such documentation will need to complete CREC certification before their IRB privileges are granted.
We recognize that many researchers come to CWRU with training in the protection of human subjects in research from another institution. We will review each case individually. You would need to provide documentation of your training/certification to the CREC Administrator for review. If we find that the training is commensurate with the CITI Basic coursework, we can enroll you in the CWRU CREC Program.
No, if they have current documentation from their institution that they have been properly trained. However, if external NIH Key Personnel have not received training from another institution they must participate in the CREC program.
Successful completion of the Collaborative Institutional Training Initiative (CITI) Basic course is the only way to enter the Case Western Reserve University's CREC program. Created by the University of Miami and used by institutions around the country, this course offers three select training groups for research faculty, staff, and students:
- Group 1 focuses on Biomedical research
- Group 2 focuses on Social & Behavioral research
- IRB Reference Resource is a compilation of both research perspectives
Please choose either the Biomedical, Social and Behavioral, or IRB Reference course. Credit will not be given for multiple BASIC courses in the same cycle. Visit the CREC Program website for additional information and instructions on how to register with the CITI Online Education Program.
No. On several of the registration forms, however, there will be a field asking for a CWRU network ID to help us link the training with the correct participant. If you have one, please provide it. If you do not have a CWRU network ID, please enter your affiliate email address.
Once you have successfully completed the Basic course, CITI will notify the CREC administrator directly. Your demographic information and grade book will be downloaded, a CREC account will be created for you in a database giving CWRU and all affiliated IRBs access for confirming your certification. This process may take up to two business days. We no longer email certificates to participants. If you need a copy of your CREC certificate, you may email the CREC Administrator or print one yourself through Spiderweb (see below).
You may access your CREC information through the Spiderweb application using a CWRU network ID and password. This site provides a portal to information about your grants, contracts, and, as applicable, regulatory protocols pertaining to the use of human subjects, animals, or recombinant DNA in your research. It also provides you with the ability to enter and retrieve data that are needed for sponsored project administration and protocols and CREC information.
To view your CREC information in Spiderweb follow these instructions:
- Go to Spiderweb.case.edu
- Enter your CWRU network ID and password
- Choose "COI/CREC Summary" from the menu on the right
- View your personal CREC history
- Additionally, in the Search box at the bottom of the page, you can type in any CREC Program participant's last name and view her/his certification status, expiration date, and download her/his certificate
After completing the core certification, researchers are certified for 3 years, during which time they must acquire 12 credits for recertification. A variety of training options are listed on the Office of Research Technology Management CREC website subheading entitled CREC Approved Training
There you'll find CWRU offers several training options eligible for CRECs including:
- The CITI Program offers additional online courses that can be taken for continuing credits. These courses include Group I Biomedical or Group 2 Social and Behavioral (8 credits), Advanced Topics (6 credits), Good Clinical Practices (6 credits), Revised Common Rule (6 credits) and Health Information Privacy & Security (4 credits). CREC Program participants may take any of these training options once per 3-year cycle.
- The CREC Recorded Seminar Series is a popular option for obtaining anywhere from 1 to 4 continuing education credits. Click on the links to watch the video presentations. Then click on the link to take the online quiz for CREC. Seminar handouts are also listed and can be printed for reference. The number of credits that will be awarded after successful completion of the quiz is listed for each seminar.
- Our CREC Seminar Series allows you to choose from a variety of seminars that have been predetermined to meet regulatory requirements. Some of these seminars such as IRB 101, as well as new hot topics, are offered each year covering basic level and more experienced researchers. Seminars are worth between 3 and 6 credits.
- Education and training activities that are not listed on this site yet focus on the ethical conduct of human subjects protection may be considered for CREC credits by submitting a CREC Credit Application along with appropriate documentation to the CWRU Office of Research Compliance. This document can be used to request credit for an individual or group.
Members have one year from their date of expiration to complete the 12 continuing education credits needed to recertify in the CREC Program. After one year, members are removed from the program and will have to complete the CITI Basic training again for re-entry.
You can purchase continuing medical education (CME) or continuing education units) (CEU), through CITI but this is not a requirement for the CREC program.