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, 45CFR, 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|
|Continuing Competence Learning Module||CE for completing the self administered Continuing Competence Learning Module||One (1) CE may be claimed|
As a rule, one (1) hour of activity = one (1) hour of CE. (45 minute presentation and 15 minute Q&A = 1 CE)
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 as a guide for evaluating CE programs.