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Recertification

Introduction

This guide describes the requirements and processes for maintaining the Canadian Association of Clinical Research Specialists credentials .i.e. (CCRS), (OCCRS), (CCRN), (CCRPA) or (CCRPh). The requirements and standards for recertification are developed and administered by CACRS Board. Additional information is available on the Association website at www.CACRS.com.

Recognizing the diversity in the scope of practice and range of approaches to professional development and continuing education for clinical research professionals regardless of the roles, CACRS developed a recertification framework that allows flexibility in the content and approaches to meet individual knowledge and professional development needs. This recertification guide outlines the types of professional activities that earn recertification credits. However, there may be other relevant professional activities not covered in this guide so we invite CACRS-credentialed professionals to contact the Program Office for guidance at certification@cacrs.com on any activities not specifically outlined in the guide.

The clinical research profession is a knowledge-driven and it is essential for competent professionals working in the clinical research industry to be familiar with changing regulations and other new and updated information related to the pharmaceutical drugs, biologics and medical devices lifecycle. Recertification reinforces the importance of advancing your knowledge and skills and enhances ongoing professional development. The professional development required to maintain the CACRS credential also helps sustain the global recognition, status and value of the credential.

To maintain the CCRS, OCCRS, CCRN, CCRPA, or CCRPh credential, each credentialed professional must earn 24 professional development credits related to the clinical research profession every two years. These credits are obtained through participation in a wide range of professional activities including completion of educational programs, speaking, writing and holding leadership roles in professional organizations.

Credentialed professionals holding more than one of CACRS credential are only required to submit a single re-certification application containing 24credits. The certification cycle for multiple credential holders is based on the date of the initial certification earned.

The primary categories for earning recertification credits and the number of credits awarded for each activity are summarized in the table below:

PROFESSIONAL DEVELOPMENT AREA CREDITS
Continuing Education and Training Activities
Educational programs and/or training directly related to the scope of practice of a clinical research professional offered by associations, higher education institutions, educational service providers, professional societies or government agencies. This includes sessions pertaining to preclinical studies activities, clinical trials activities, quality assurance or quality control, compliance, pharmacovigilance and other clinical research or relevant regulatory topics.

1 credit per hour

3 credits per half day 6 credits per day

Online or other self-study courses related to the scope of practice of clinical research professionals offered by a qualified clinical research training provider

1 credit per course hour

12 credits maximum per course

Web-based conferences about topics relevant to the scope of practice of clinical research professionals

1 credit per hour

1.5 credits per 90 min

PROFESSIONAL DEVELOPMENT AREA CREDITS
Training and/or education related to the biomedical/healthcare sector; scientific, clinical or engineering disciplines; business; law or other fields. This includes sessions pertaining to the individual’s primary technical/scientific field, general business/management, or other disciplines or topics not specifically focused on clinical research related issues.

1 credit per hour

3 credits per half day 6 credits per day

University courses related to the scope of practice of clinical research professionals. This may include coursework related to business management. Courses must be full quarter or semester courses. 15 credits per semester; 10 credits per quarter with maximum of 24 credits per year
Additional Professional Credentials Earned
Additional CACRS credentials earned. Successful attainment of an additional CACRS credential must occur during the two-year certification period. 20 credits per credential

Other relevant professional credentials earned (e.g., quality, clinical research, project management). Successful attainment of an additional credential must occur during the two-year certification period.

5 credits per credential
Course Organizer, Faculty, Speaker
Faculty, instructor or speaker at a training or educational program, course or CACRS study group directly related to the scope of practice of a clinical research professional requiring preparation of course materials or handouts in addition to presentation. Subject matter may include business and management functions. 4 credits per hour of instruction
Faculty or instructor at a clinical research-related course offered by a university or college, requiring lecture and preparation of course materials. Presentations that are repeated may not be included unless content has been revised. 4 credits per hour of instruction 12 credits maximum per course
Panel member or respondent on clinical research topics and issues panel not requiring preparation of course materials or handouts. 2 credits per hour of presentation
Member of organizing or planning committee for a clinical research or related training and/or educational program, course or conference track or session. Additional credits can be earned for speaking at this event (see above for speaker credits). Presentations should be noted separately from role as organizer. 2 credits per program, course
Instructor or speaker on clinical research related presentations or training programs within your organization. If presentations are offered on a single topic throughout a year, list topic and total presentations for the year. This does not include presentations completed about company-specific information which is part of one’s paid position. 4 credits per hour of instruction

Articles, Books and Other Published Content

(May include materials published in print and/or electronic format.)

An article and/or chapter about clinical research related topics, issues or advances published in a newsletter, magazine, journal, book, or as a monograph or booklet. 5 credits per article
Author of a book addressing issues/topics relevant to the regulatory profession. Based on length and topic; maximum of 15 credits
Editor, member of editorial or peer-review board of journal, magazine or book related to the clinical research profession requiring publication planning, author management and review. 5 credits per publication
Brief editorial or column (less than one printed page) and/or Letter to the Editor related to research issues and published in a professional publication. 1 credit each
Internet website developer, manager or editor for sites related to clinical research profession. Credits determined on review by CACRS
Leadership in Relevant Professional and Trade Organizations

Officer or board member.

2 credits per year of service

Committee or section chairman.

2 credits per year of service

Member of a committee, task force, council or other appointed group.

1 credit per year of service

CACRS certification Program Office may identify other special initiatives including participating in research studies, that are eligible for recertification credits. These special initiatives and other eligible professional development opportunities will be announced to CACRS certified professionals via email and on the CACRS website.

CACRS certified professionals may also contact the CACRS Program Office via certification@cacrs.com and request consideration of professional development activities not covered in the above categories.

Determined on a case-by-case basis

Most CACRS certified professionals will find it effective to maintain an ongoing record of their professional development activities by using Professional Development Tracker form which can be used to record professional development activities. This form must be submitted with the recertification application.

The CACRS Program Office audits a small percentage of recertification applications. Supporting documentation for listed credits is not required with submission of the recertification application, but must be submitted upon request. The CACRS certification Program Office is randomly select applications for audit from all submitted applications.

Professionals who hold a CACRS credential must recertify every two years. The testing cycle will remain the basis for recertification of all credentials if additional CACRS credentials are earned.

Credentialed professionals receive information about certification expiration dates in the initial certification confirmation letter. All communication about recertification will be via email certfication@cacrs.com. It is the credentialed professional’s responsibility to ensure that the CACRS Program Office has up-to- date contact information. Credentialed professionals who fail to recertify by the due date will be removed from the list of CACRS certification holders until they reinstate their CACRS certification/recertification status.

A Recertification Application may be submitted at any time once 24 credits are accumulated within the two-year certification period. Credits must be earned within the two-year certification period. Credits earned in one recertification cycle cannot be transferred to another recertification cycle.

Credentialed professionals holding more than one CACRS credential are only required to submit a single recertification application containing 24 credits. The recertification cycle for multiple credentials is based on the date of the initial certification earned.

CACRS credentialed professionals must complete and submit the CACRS Recertification Application and Professional Development Tracker listing the date, title and credits awarded for each professional activity completed within the current two-year cycle. The Recertification Application and Professional Development Tracker are available at the end of this Guide or on at CACRS.com/certification/maintenance.

For applications submitted by the certification expiration date, the recertification fee is $350 (CAD) for CACRS members and $480 (CAD) for nonmembers. Payment must accompany the CACRS Recertification Application submission. Applications will not be accepted without payment. For applications submitted after the certification expiration date but within one year, late fees apply and must be submitted in addition to the recertification fee. For CACRS members, the late fee is $120. For non- members, the late fee is $250. Applications submitted more than one year after the certification expiration date will not be accepted.

Payment must accompany a completed application. You may submit your completed application and payment in the following ways:

Payment Type Application Submission Method
Credit Card You can pay online or please complete the recertification form and email to: certification@cacrs.com
Check Or Money Order

Postal mail only to:

Canadian Association of Clinical Research Specialists

14 Collingwood Avenue

Brampton, Ontario

L7A 2E5

Canada

International Wire Transfer Please send email at certification@cacrs.com and we will provide you with all relevant bank information. For all wire payments: email (certification@rcacrs.com) a completed form and copy of bank wire confirmation to confirm your registration.

CACRS-credentialed professionals will be notified via email of the acceptance of their recertification application. Individuals who submit a recertification application but do not meet the recertification requirements will be notified via email.

Credentialed professionals who do not acquire at least 24 applicable professional development credits by the within the two-year certification period or who fail to submit a completed Recertification Application with Professional Development Tracker will have the CACRS status revoked. The individual will not be listed as a CACRS credentialed professional until meeting the conditions for reinstatement of the CACRS credential.

The CACRS credential can be reinstated if recertification credits and fees are submitted within one year of the certification expiration date.

Recertification credits must be obtained during the two-year certification period. The recertification fee plus the late fee must be submitted with the completed CACRS Recertification Application and Professional Development Tracker. CACRS-credentialed professionals who recertify after, but within one year of, the certification expiration date, will maintain the original certification expiration date. The certification expiration date will not be adjusted based on the date of the late submission.

After the one-year delinquency period, individuals will be required to retake the CACRS certification examination in order to reinstate CACRS certification status.

Failure to recertify within one year of the certification expiration date will inactivate all CACRS certification credentials held by a credentialed professional. However, retaking the examination for one of the previously held CACRS credentials will reinstate all previously held CACRS credentials.

A temporary waiver of recertification credits will be extended if:

  • A CACRS certified professional does not currently hold a paid position related to the clinical research profession.
  • A CACRS certified professional is elected or appointed to full-time public office at the local, state or national level.
  • A CACRS certified professional has a serious illness and/or disability limiting the professional’s ability to meet the recertification requirements.

A request for waiver must be submitted in writing 60 days prior to the certification expiration date. Individuals granted a temporary waiver will be listed as a CACRS certified for up to 12 months. If the individual fails to recertify during the 12 month period, they will no longer be listed as a CACRS certified and must re-take the certification examination to reinstate CACRS certification status.

CACRS-credentialed professionals may appeal any adverse decision regarding recertification made by the CACRS Program Office. An appeal must be initiated, in writing, by the affected individual within 30 days of the adverse decision. The appeal should be sent to the CACRS In care of the CACRS Program Office.

The CACRS Board will address all appeals and may contact the individual to request additional information as needed. Decisions made by the CACRS Board regarding the appeal will be final.

Canadian Association of Clinical Research Specialists

Attention: CACRS Program Office

514 Collingwood Avenue

Brampton, Ontario

L7A 2E5

Canada

Email: certification@cacrs.com

CACRS.com