SOCRA Certification Exam

Certification Program Policies

Appeals

All appeals must be sent in writing to SOCRA Re: Certification Appeal by e-mail to office@socra.org , mailed to 530 West Butler Avenue, Suite 109 Chalfont, PA 18914 USA, or faxed to: (215) 822-8633.

Certification of Honesty

Falsification or misrepresentation of application information will invalidate the applicant’s certification status. This would include disapproval of the application or revoking of certification.

Confidentiality Statement

The SOCRA Certification Committee (the “Committee”) will take all reasonable measures to ensure that any material, reports, proceedings, and/or hearings related to the certification process shall remain confidential between the Committee and the candidate except as required by law, authorized in writing by the candidate, or as otherwise provided in the Committee’s Policies and Procedures.

Policy of Non-Discrimination

SOCRA does not discriminate on the basis of gender, race, color, age, marital status, sexual orientation, national origin, religion, or disability.

Special Needs / Disability Accommodation Policy

SOCRA – Society of Clinical Research Associates supports the intent of, and complies with the Americans with Disabilities Act (“ADA”). The Society of Clinical Research Associates will take steps reasonably necessary to make its assessment programs accessible to persons with disabilities covered by the ADA. An applicant may request a change in certification procedures or process due to a disability, handicap, or other reason. Appropriate and effective modifications and/or auxiliary aides will be provided to persons with such disability, handicap, or other reason unless doing so would impose an undue burden on the Society of Clinical Research Associates’ programs or fundamentally alter the measurement of skills or knowledge that the programs are intended to test. The Society of Clinical Research Associates certification examination does not discriminate against any candidate based on age, sex ethnic origin, religion, race, disability or marital status.

SOCRA will make every effort to accommodate applicants with special needs. If the applicant has special physical or testing needs due to a disability, handicap, or other reason, the applicant should attach a written request for accommodation with the certification application and at least six weeks in advance of the examination date. The written documentation should include a diagnosis or description of the disability or special need, the current level of functioning, and the requested accommodation. This statement must be written by a qualified medical professional (preferably a physician) and should be submitted on the letterhead of the medical professional or their institution or organization.

All special arrangements must be made and agreed upon in advance; such arrangements cannot be made at the time an examination is given. The Society of Clinical Research Associates will make the final determination as to the necessary accommodations for an individual with a verified disability.

For individuals with physical, visual or learning disabilities requiring an extended test time, there is no accommodation for untimed testing. Time and a half (6 hours) is appropriate accommodation for most disabilities. Double time (8 hours) may only be granted in special circumstances with the recommendation of qualified professionals.

At this time, SOCRA does not have an auditory examination for the visually impaired.

Test Center Policies & Procedures

Test Center Policies and Procedures may be found here.

Requirements for Maintaining Certification

Term of Certification / Certification Period

The certification period is 3 years, beginning on the date of most recent certification and ending on certification expiration date.   All CE must be accrued during this time period.

Maintenance of Membership

Membership must remain current during your certification period.   Annual renewal of membership and payment of membership renewal fees ($75/year) is required.  It is the responsibility of the certificant to maintain membership.  SOCRA, as a courtesy, sends membership renewal reminder by email 2 months prior to the membership expiration date.

Continuing Education Requirement

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.

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.  More information regarding recertification can be found under the Recertification section of the website.

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 recertification quiz.

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.  Please see CE Recordkeeping Requirements for more details.   A random audit of programs submitted for CE credit will be conducted each year.

Because of the diversity of SOCRA membership, a specific listing of approved CE programs will not be developed.  TheDescription of Acceptable CE overview 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.  Only educational hours may be claimed for CE; you may not claim CE credit for your work hours.

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.   See CE Recordkeeping Requirements for more details on documentation requirements.

Categories of CE

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 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.

Descriptions of Acceptable CE

Please review the Description of Acceptable CE for more details and a guide for evaluating CE programs.

Descriptions of Acceptable CE

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-mailed to SOCRA at: recertification@socra.org directed to the attention of the Certification Committee.

The Examples and Description of Acceptable CE table serves as a guide for evaluating CE programs.

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, AND2. 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, AND2. 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, AND2. 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, AND2. Letter signed by supervisor stipulating learning hoursNOTE: 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 requiredNote: One year of such participation = one CE hour	Maximum = 1 CE per year	Maximum = 3 CE per certification period

CE Recordkeeping Requirements
Recordkeeping
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.

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 quiz when applying for recertification. Click here to download the CE Tracking Log.

CE Documentation Retention Requirements

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. 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.”

Renewal of Certification

Certification of Clinical Research Professionals by SoCRA is based on a continuing process of professional experience and education. The CCRP Recertification 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.

Certification Maintenance

During the 3-year certification period, certificants must follow the requirements for maintenance of certification.  TheMaintenance of Certification section of the website outlines the:

• Requirements for Maintaining your Certification,
• Continuing Education Requirements,
• Descriptions of Acceptable CE, and
• CE Recordkeeping Requirements.

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.

The requirements for recertification include:

• Current Certification and Current Membership  – A certificant wishing to recertify must be a member in good standing with a current certification. When a membership lapses, the CCRP® credential will automatically be suspended/removed.
• Application for Recertification – A certificant wishing to recertify must complete the application for recertification, CE log and quiz.   These documents, along with the recertification processing fee (currently $100 USD), must be submitted to the SOCRA office prior to the certification expiration date.  More details may be found on under the Applying for Recertification section of the website.

Applying for Recertification

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

Recertification Reminder Packet

A recertification reminder packet is mailed to the certificant 2 ½ months before their certification expiration date.   The packet includes a recertification application, recertification quiz, and answer sheet.   If you do not receive the recertification packet by mail at least 2 months before your certification expiration date, please contact the SOCRA office.

Recertification Application Submission

To apply for recertification, applicant’s must complete and submit the following to the SOCRA administrative office BEFORE their certification expiration date:

• Recertification Application – included in the Recertification Reminder Packet or may be downloaded here
• Recertification CE log – A log of completed continuing education must be submitted with your recertification application packet.   This log must include 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.  Please review the Continuing Education Requirements for more detailed information.  You may also download the CE Tracking Log, an excel based tool for logging and tracking continuing education (CE) hours.
• Recertification Knowledge Quiz – The quiz will be sent to you with your recertification packet.  The quiz 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.
• Recertification Processing Fee – Submission of the $100.00 recertification processing fee in U.S. Funds to the SOCRA office.

* A printable version of the Recertification Application and Requirements for Maintaining your Certification may also be downloaded here.

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.