Overview of Recertifications

Recertification ensures that individuals who are credentialed as Certified IRB Coordinators or Certified IRB Managers maintain their commitment to ongoing professional development in Human Research Protection Programs. The field of human subject research is knowledge driven and continual learning and professional development are essential to ensure that certified professionals be aware of regulatory changes that impact the conduct of research and the safety of research subjects. The goal of all research professionals is to assure the safety of all human subjects participating in research studies.

Recertification Requirements

1. Recertification is required every three years. 
2. Applicants may recertify by completing 30 hours of Continuing Education Credits (CECs) for a $150.00 fee or by retaking the Certification Examination for a $300.00 fee.
3. Fees are due at the time the application is submitted.
4. Applicants may recertify one time, within a six year period, by obtaining 30 hours of Continuing Education Credits (CECs) during the three year certification period. 
5. Applicants must retake the Certification Examination every sixth year.
6. Completion of 30 hours of Continuing Education Credits (CECs) applicable to work in Human Research Protections Programs, IRB functions, regulations pertaining to the conduct of clinical research and the protection of human subjects, and IRB processes is required.
7. All 30 hours of Continuing Education Credits (CECs) must be completed during the three year certification period.
8. All applicants must complete the Recertification Application. 
9. All applicants recertifying by CEC’s must complete the Recertification Continuing Education Credit Log.

Continuing Education Documentation Requirements

The applicant is responsible for maintaining copies of Continuing Education Certificates and documentation for three years after the certification time frame. 

If a certificate of attendance or completion is not available, you must provide the following:

1. Program description or agenda from the continuing education program AND
2. A copy of the sign-in sheet or a Letter from the Program Sponsor indicating attendance and the number of continuing education hours received.

Acceptable Continuing Education Activities

Acceptable Providers of Continuing Education Activities include but are not limited to:

1. National Associations
   • Association of Clinical Research Professionals (ACRP)
   • Drug Information Association (DIA)
   • MAGI Conference
   • Society of Clinical Research Associates (SoCRA)
   • Society of Research Administrators (SRA) International
   • Central Society for Clinical and Translational Research (CSCTR)
   • Society for Clinical Trials (SCT)
   • Regulatory Affairs Professionals Society (RAPS)
   • Public Responsibility in Medicine and Research (PRIMR)
2. Federal Agencies
   • Food and Drug Administration (FDA)
   • Office of Human Research Protections (OHRP)
   • National Institutes of Health (NIH)
3. Other Healthcare Related Associations
   • National and State Nursing Associations
   • Accreditation Council for Continuing Medical Education (ACCME)
   • American Council on Pharmaceutical Education (ACPE)
4. Healthcare Related University Courses – Provide transcript
5. Regional or Local Educational Presentations
6. On-line Continuing Education Courses – Related to IRBs, regulatory updates, clinical research, etc.

Continuing Education Credit Log

All applicants must complete the Recertification Continuing Education Log. 

Required information includes:

1. Program Date(s)
2. Name of Program Provider
3. Program Title
4. Location
5. Number of Continuing Education Credits provided
6. Attendance verification – certificate of attendance or transcript
7. Type of Program – regulatory, clinical research etc.

Calculating Continuing Education Activity

A Continuing Education Credit (CEC) is a method of tracking that allows individuals to document their involvement in various professional development activities. 

CEC = Continuing Education Credit

1 CEC = 1 Contact Hour of Education

Recertification Audit

A random audit of approximately 10% of the previous year’s recertification applications will be conducted each year. If you are selected, you will be required to submit your recertification application, recertification continuing education log and all supporting documentation including certificates of attendance and other appropriate documentation.

If you are unable to provide all of the required documentation, your certification will be revoked.

Failure to Recertify or Failure to Complete Recertification Requirements

Certified individuals who do not complete the required 30 hours of Continuing Education Credits or fail to submit the recertification application by the recertification date will have to retake the Certification Examination. 

Recertification Certificate

Recertification Certificates will be mailed to the “home mailing address” listed on the Recertification Application within 30 days

Recertification Payment Information

The Recertification Fee is $150.00 by CEC’s or $300.00 by retaking the exam. 

Applicants will pay online via PayPal through the application form

If you have any questions about the Recertification Process or the information required, please contact PCS Testing at 781-275-4252.