Recertification

Recertification

Declaring Continued Proficiency

Continuing Education (CE) Units - Explanation

Request for SoCRA CE for Courses/Workshops Offered by Others

Guidance for Industry
E6 Good Clinical Practice: Consolidated Guidance (PDF)

Recertification Application

Continuing Education (CE) Units - Explanation

Recertifying Before January 1, 2010

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.

A SoCRA member wishing to re-certify must be a member in good standing with a current certification. Re-certification is required every three years and the candidate 1) must have completed 45 hours of Continuing Education applicable to their work in clinical research during the current three years of certification, and 2) must successfully complete a self-administered knowledge test that will be included with the three-year re-certification reminder package.

Because of the diversity of SoCRA membership, a specific listing of approved CE programs will not be developed. Members applying for re-certification will be asked to sign an affidavit that verifies an accumulation of 45 hours of Continuing Education applicable to their work in clinical research. Such education should apply to the candidate's (therapeutic/scientific) area of clinical research or to clinical research regulations, operations or management.

It is the responsibility of the applicant to maintain copies of certificates of completion/attendance, OR program descriptions/ agendas and some 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:

a letter from meeting host which should verify attendance and hours of CE,
a copy of official meeting sign-in sheet,
a personal name tag with logo or name of program host, or
a 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, and/or hotel receipts. Such items cannot assure an auditor that a candidate attended a program.

A random audit of documentation submitted for CE credit will be conducted each year.

Examples of acceptable programs include:

Workshops at research bases or pharmaceutical company meetings encompassing subjects appropriate to clinical research (one classroom hour = one CE hour).
Programs developed and/or endorsed by SoCRA (one classroom hour = one CE hour).
Seminars, conferences, programs including web-based training, or institutes (applying to clinical research) that contribute to education or professional advancement (one classroom hour = one CE hour).
College, university, or accredited independent study courses relevant to work in clinical research (one semester hour college credit = 10 hours of CE for SoCRA re-certification).
Grand rounds, tumor boards, and Institutional Review Board meetings (maximum of two hours of CE may be credited from all of these areas combined, per year).

The following types of CE may account for (up to) five hours of re-certification credit per year (one hour of this activity = one CE hour). After completion of this type of CE, the applicant must write a half page (250 word) summary and keep that summary on file with other CE documentation for audit purposes.

Audio and video tapes of CE programs related to clinical research (state, chapter or association meetings, area or local chapter meetings, etc.). Tapes must be one hour in length for each hour claimed.
Reading of journal articles, self study programs and professional study groups may be claimed in one-hour increments for each hour spent on the activity. SoCRA Source articles with completed self-test exams do not require summaries.
Active participation in SoCRA as an elected officer, committee chair or active committee member, for SoCRA or a SoCRA chapter. This type of activity may account for (up to) three hours of re-certification credit over three years (one year of such participation = one CE hour, maximum one CE hour credit per year).

Recertifying After January 1, 2010

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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."

Guidance for Industry
E6 Good Clinical Practice: Consolidated Guidance

Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software)

Click Here to view/print the "Guidance for Industry" (198 KB) in Adobe PDF format.