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Recertification
Declaring
Continued Proficiency
Overview of the CCRP Recertification Program
Requirements for Maintenance of CCRP® Credential
Requirements for CCRP® Recertification
Recertification
Continuing Education (CE) Requirements
Request for SoCRA CE for Courses/Workshops Offered by Others
Overview of the CCRP Recertification Program
Certification of Clinical Research Professionals by SoCRA is based on a continuing process of professional experience and education. This program is dedicated to providing recognition and validation of the professional growth of the individual “CCRP®” to the healthcare community. The goal is to assure the safety of human research participants and improve the health of people around the world.
An overview of information regarding CCRP maintenance, continuing education requirements, and recertification can be downloaded here.
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.
Any question regarding the appropriateness of a program for CEUs may be e-mail to SoCRA at: recertification@socra.org directed to the attention of the Certification Committee. More information can be found below.
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Requirements for Maintenance of CCRP® Credential
Certification Period / Term of Certification
The certification period is 3 years, beginning on the date of most recent certification and ending on the certification expiration date. All Continuing Education (CE) must be accrued during this time period.
Maintenance of Membership
Membership renewal is required annually. An annual membership renewal reminder will be sent by email. It is the responsibility of the certificant to assure that membership dues are current. To assure that relevant communication regarding membership and certification is received; certificants should update the SoCRA administrative office with any changes to contact information.
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.
CE Recordkeeping
Please use the CE Credit Tracking Log to complete information for each continuing education program to be applied to your recertification. This tracking log requires that you select a category and type of CE.
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.
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Requirements for CCRP® Recertification
Recertification
Recertification is required every three years and the candidate 1) must have completed 45 hours of Continuing Education (CE) applicable to their work in clinical research during their certification period, and 2) must successfully complete a self-administered knowledge test that will be included with the three-year recertification reminder package. CCRP® certificants wishing to re-certify must submit their Recertification Application and fee to the SoCRA administrative office prior to their certification expiration date. Fees are non-refundable.
Recertification Reminder Packet
A recertification reminder packet is mailed 2 ½ months before your certification expiration date. The packet includes a recertification application, recertification quiz, and answer sheet.
Recertification Application
The recertification application must be completed and submitted with payment to the SoCRA administrative office BEFORE your certification expiration date.
Recertification Quiz / Self-Administered Knowledge Test
The test is open-book but must be completed independently. Please be sure to select only one answer per question. It is suggested that you include the source to the answer on the test answer sheet.
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Recertification
Renewal of Certification
In order to maintain active certification status, the CCRP® must apply for renewal of certification to the Certification Committee every three years. The requirements for recertification include:
- Completion of the recertification application, and CE log, indicating the required forty-five (45) contact hours of continuing education, applicable to work in clinical research, during the period after the most recent certification date,
- Completion of a self-administered open-book recertification quiz that will be included in the recertification packet to be mailed to each member due for recertification, AND
- Submission of the $100.00 recertification processing fee in U.S. Funds to the SoCRA office.
A SoCRA member wishing to re-certify must be a member in good standing with a current certification. When a membership lapses, the CCRP® credential will automatically be suspended/removed. Recertification Audit
An audit is performed in the spring each year selecting up to 10% of the previous year’s recertification applications. 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. For example, if you re-certify in February of 2013, you may be selected for audit in the spring of 2014.
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Continuing Education (CE) Requirements
Certification of Clinical Research Professionals by SoCRA is based on a continuing process of professional experience and education. This program is dedicated to providing recognition and validation of the professional growth of the individual CCRP® to the healthcare community.
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 quiz. Only educational hours may be claimed for CE; you may not claim CE credit for your work hours.
It is the responsibility of the certificant to maintain copies of program descriptions or agendas, and some form of verification of attendance such as a certificate of completion or letter of attendance or notice of grade, or class completion certificate. A random audit of programs submitted for CE credit will be conducted each year.
Explanation of CE
Because of the diversity of SoCRA membership, a specific listing of approved CE programs will not be developed. 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. Only educational hours may be claimed for CE; you may not claim CE credit for your work hours.
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 Operations / Regulatory |
CE related to clinical research regulations, policy, operations, etc. |
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, etc.)
|
No minimum |
| Recertification Quiz |
CE for completing the self administered knowledge test |
One (1) CE may be claimed |
How to Calculate Continuing Education (CE)
As a rule, one (1) hour of activity = one (1) hour of CE. (45 minute presentation and 15 minute Q&A = 1 CE)
For example; One classroom hour of learning = One CE hour
For college courses; One (1) semester hour of college credit = ten (10) hours of CE
For Audio/Video; Tapes must be one hour in length for each hour claimed.
Continuing Education (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.
Cerification 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.
Continuing Education (CE) Credit Tracking Log
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 quiz when applying for recertification. Click here to download the CE Tracking Log.
Retention of Supporting Documentation
A CE tracking log may be downloaded from the SoCRA website to assist you in keeping track of your CE. Please retain all original certificates of attendance and documentation for 2 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. The Examples and Description of Acceptable CE table serves as a guide for evaluating CE programs.
Examples and Descriptions of Acceptable CE
Examples of acceptable programs include:
Type 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 |
| Web Based / Online Coursework |
Education related to clinical research or therapy |
| Other Seminars/ Conferences |
Seminars, conferences, programs (applying to clinical research) that contribute to education or professional advancement |
| 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
|
| 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) |
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 |
Summary of studied material (minimum 250 words)
Self-Study Articles with completed self-test exams do not require summaries.
|
Maximum=5 CE per year |
Maximum= 15 CE per certification period |
| 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. |
| 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 |
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Request for SoCRA CE for Courses/Workshops Offered by Others
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."
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