Maintenance of Certification

Requirements for Maintaining Certification

It is the responsibility of the certificant to assure that their certification is current and in good standing. The certification period is three years, beginning on the date of most recent certification and ending on the certification expiration date.

Accruing Continuing Education (CE): All CE must be accrued during your certification period. We suggest that you keep an ongoing log of accrued CE to assure that you are keeping up to date on the requirements for maintenance of CE. Certificants must have completed 45 hours (45 credits) of CE during their certification period. A minimum of 22 CE must be related to Clinical Research regulations, policy, etc. The remaining CE may relate to your Therapeutic or Professional Area. 1 CE will be awarded for the successful completion of the recertification continuing competence learning module. Only educational hours may be claimed for CE; you may not claim CE credit for your work hours.

CE Record keeping: Please use the CE Credit Tracking Log to complete information for each continuing education program to be applied to your recertification. You may download the CE Tracking Log here.

CE Documentation Retention: Please retain all original certificates of attendance and documentation for two years after your certification period ends. This documentation will not be submitted with your recertification application; however, if selected for recertification audit, your recertification application, CE tracking log, and supporting documentation (including certificates of attendance and other documentation) will need to be submitted. If you are unable to produce this supporting documentation at that time, your certification will be revoked. A recertification audit is performed in the spring of each year, selecting up to 10% of the previous year’s recertification applications. For example, if you recertify in February 2019, you may be selected for audit in the spring of 2020.

Recertification / Certification Renewal: In order to maintain active certification status, the CCRP® must apply for renewal of certification to the Certification Committee every three years.

Recertification Details

Apply for Recertification

Your Path to Maintaining Certification

Step 1:
Earn the CEs

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Step 2:
Track all CE Credits

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Step 3:
Apply & Pay Fees

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Step 4:
Retain Documentation

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More Information

Continuing Education Requirements

Certificants must complete 45 hours (45 credits) of CE during their certification period. A minimum of 22 CE must be related to Clinical Research regulations, policy, etc. The remaining CE may relate to your Therapeutic or Professional Area. 1 CE will be awarded for the successful completion of the Continuing Competence Learning Module.

The table below explains the breakdown of CE that you may claim within each CE category:

Category of CE	Description of Category	Amount of CE Allowable	Total CE Required
Clinical research Regulatory / GCP	CE related to clinical research regulations, policy, GCP, falling under the umbrella of 21CFR, 45 CFR, ICHE6	Minimum of 22 CEU may be claimed (no maximum)	45 CE per 3 year certification period
Therapeutic / Professional Area	CE related to your specialty in research (therapy, treatment, professional specialty, etc.)	No minimum	45 CE per 3 year certification period
Continuing Competence Learning Module	CE for completing the self administered Continuing Competence Learning Module	One (1) CE may be claimed	45 CE per 3 year certification period

How to Calculate Continuing Education (CE) Credits

As a rule, one (1) hour of activity = one (1) hour of CE. (45 minute presentation and 15 minute Q&A = 1 CE)

Live Conferences / Webinars: One classroom hour of learning = One CE hour
College Courses: One semester hour of college credit = 10 CE hours
Enduring Material (Audio/Video/Web): One hour of learning = One CE hour

CE Documentation Requirements

It is the responsibility of the applicant to maintain copies of certificates of completion/attendance, OR program descriptions/agendas from the CE activity and a form of verification of attendance. If a formal certificate of completion or attendance is not available, please send one form of verification with the meeting description or agenda. Verification may include any one of the following forms:

1) letter from meeting host which should verify attendance and hours of CE,

2) copy of official meeting sign-in sheet,

3) personal name tag with logo or name of program host,

4) notice of grade received or class transcript

Examples of items that DO NOT qualify as proof of meeting attendance include: notification of meeting, flight schedules, boarding passes, hotel receipts. Such items cannot assure an auditor that a candidate attended a program.

Retention of Supporting Documentation: A CE tracking log may be downloaded here to assist you in keeping track of your CE. Please retain all original certificates of attendance and documentation for two years after your certification period ends, and submit such documentation only when requested to do so for audit purposes. A random audit of documentation submitted for CE credit will be conducted each year (up to 2 years after your certification period ends).

CE Validation: SOCRA’s requirements for recertification CE credit are quite general, as they pertain to research regulations, operations and management, and yet are also specific to the therapeutic area of the research in which the candidate participates. We therefore leave it to the candidate to determine whether a course or program is acceptable for the individual’s CE requirement, and we do not “validate” individual training courses/workshops/presentations. Use the Description of Acceptable CE table below as a guide for evaluating CE programs.

Descriptions of Acceptable CE

Because of the diversity of SOCRA membership, a specific listing of approved CE programs will not be developed. The Description of Acceptable CE table below serves as a guide for evaluating CE programs. Certificants applying for recertification will be asked to sign an affidavit that verifies an accumulation of 45 hours of CE applicable to their work in clinical research. CE credit may not be claimed for work hours or work specific training. For example, CE cannot be claimed for protocol-specific or study specific training; time spent reviewing protocols, or training on institutional policies and procedures.

Examples of acceptable programs include:

Types of Activity	Description of Activity	Supporting Documentation Required (submit ONLY if audited)	Maximum CEU Allowed
SOCRA Conference/ Workshop/ Chapter Meeting	Programs developed by SOCRA and SOCRA Chapter Meetings offering CE	Certificate of attendance	No Maximum
Workshops at research facilities/sites	Workshops at research facilities/sites or pharmaceutical company meetings encompassing subjects appropriate to clinical research.	1. Agenda, AND 2. Certificate of attendance and/or letter signed by supervisor	No Maximum
Web Based / Online Coursework	Education related to clinical research or therapy, including free CITI training through SOCRA	1. Agenda, AND 2. Certificate of attendance and/or letter signed by supervisor	No Maximum
Other Seminars/ Conferences	Seminars, conferences, programs (applying to clinical research) that contribute to education or professional advancement	1. Agenda, AND 2. Certificate of attendance and/or letter signed by supervisor	No Maximum
University/ College Coursework	College, university, or accredited independent study courses relevant to work in clinical research.	1. Transcript showing completion of course, AND 2. Syllabus/course description	No Maximum
Grand rounds, Tumor Boards, and IRB / IEC meetings	Grand rounds, tumor boards, and Institutional Review Board (IRB) / Independent Ethics Committee (IEC) meetings	1. Agenda, AND 2. Letter signed by supervisor stipulating learning hours	Maximum = 2 CE from all of these areas combined, per year Maximum = 6 CE per certification period
Investigator / Site Initiation Meetings	CE can be claimed for the GCP training given at investigator meetings and site initiation visits (not for protocol specific training)	1. Agenda, AND 2. Letter signed by supervisor stipulating learning hours NOTE: Only the GCP training sections of the meetings may be claimed.	Maximum = 2 CE from all of these areas combined, per year Maximum = 6 CE per certification period
Audio/Video	Audio and video recordings of CE programs related to clinical research (state, chapter or association meetings, area or local chapter meetings, etc.). Recordings must be one hour in length for each hour claimed.	Summary of studied material (minimum 250 words) For each audio and video recording claimed	Maximum = 5 CE per year Maximum = 15 CE per certification period
Self-Study / Journal Articles	Reading of journal articles and self study programs may be claimed in one-hour increments for each hour spent on the activity. 1 hour of this activity = 1 CE SOCRA Source Self Study article(s) offers 1 CE each. You may use articles from issues published during your certification period only 12 issues are published during a 3-year certification period.	A copy of the completed SOCRA self-test exam for each article (signed and dated)	Maximum = 4 CE per year Maximum = 15 CE per certification period
Active SOCRA officer, committee chair/member	Active participation in SOCRA as an elected officer, committee chair or active committee member for SOCRA or a SOCRA chapter.	No documentation required Note: One year of such participation = one CE hour	Maximum = 1 CE per year Maximum = 3 CE per certification period

CE Recordkeeping Requirements

Certification may include any one of the following forms:

- letter from meeting host which should verify attendance and hours of CE,
- copy of official meeting sign-in sheet,
- personal name tag with logo or name of program host,
- notice of grade received or class transcript
- Examples of items that DO NOT qualify as proof of meeting attendance include: notification of meeting, flight schedules, boarding passes, hotel receipts. Such items cannot assure an auditor that a candidate attended a program.

CE Tracking Tool
SOCRA created an Excel based tool that members may download to help log and track their continuing education (CE) hours. We strongly suggest that certificants use this log to track their CE. The completed spreadsheet can then be submitted with the recertification application and learning module when applying for recertification. Click here to download the CE Tracking Log. You can also view a sample CE Tracking Log here.

CE Documentation Retention
Please retain all original certificates of attendance and documentation for 2 years after your certification period ends. The certificates of attendance and documentation will not be submitted with your recertification application. However, if selected for recertification audit, these certificates of attendance and documentation will need to be submitted. If you are unable to produce this supporting documentation at that time, your certification will be revoked. We suggest that you also retain a copy of your recertification application and CE tracking log submitted with your recertification application. A recertification audit is performed in the spring of each year, selecting up to 10% of the previous year’s recertification applications.

Request for SOCRA CE for Courses / Workshops

SOCRA’s requirements for recertification Continuing Education credit are quite general, as they pertain to clinical research regulations, operations and management, and to the therapeutic area of the clinical research in which the candidate participates. We therefore leave it to the candidate to determine whether a course or program would be acceptable for SOCRA’s CE requirement. SOCRA does not “validate” individual training courses/workshops.

Organizations offering courses may use the following text in their brochure/announcement:

“The Society of Clinical Research Associates (SOCRA – www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers __ hours of CE credit.”