Direct comparison
RAC vs. CCRP Certification Compared
RAC (RAPS) certifies regulatory affairs across a product's lifecycle; CCRP (SOCRA) certifies clinical trial conduct. Compare scope, eligibility, and exams.
Side-by-side comparison
| Dimension | RAC (RAPS) | CCRP (SOCRA) |
|---|---|---|
| Full name | Regulatory Affairs Certification | Certified Clinical Research Professional |
| Administering body | Regulatory Affairs Professionals Society (RAPS) | Society of Clinical Research Associates, Inc. (SOCRA) |
| What it certifies | Competency in regulatory affairs -- the strategy and mechanics of getting healthcare products authorized and keeping them compliant | Competency in running a clinical trial to protocol and Good Clinical Practice (GCP) -- informed consent, data integrity, participant safety, essential documents |
| Scope across the product lifecycle | Broad: premarket strategy, submissions (e.g. IND, 510(k)), labeling, advertising/promotion review, and post-market compliance -- clinical trials are only one phase this touches | Narrow and deep on one phase: the conduct of the clinical trial itself, from site activation through closeout |
| Specialization tracks | RAC-Drugs and RAC-Devices -- candidates choose the track matching their product-type focus | Single generalist credential -- no separate tracks by product type or by coordinator/associate role |
| Typical candidate background | Regulatory affairs specialists, submission writers, compliance officers, QA/QC staff moving into regulatory roles | Clinical research coordinators (CRCs), clinical research associates (CRAs), and other site- or sponsor-side trial-conduct staff |
| Eligibility (typical pathway) | Bachelor's degree + 3 years regulatory-related experience, master's + 2 years, doctorate + 1 year, or 10 years of regulatory experience with no degree requirement | Most common pathway (Category 1): 2 years full-time clinical-research experience within the last 5 years (or 3,500 part-time hours), under GCP on an IRB/IEC-approved protocol -- no specific degree required; alternate pathways exist for candidates with a clinical-research-specific degree or certificate |
| Exam delivery | Computer-based, via Pearson VUE | Computer-based testing, year-round |
| Recertification cycle | Periodic recertification through RAPS' own RAC Recertification program | Every 3 years: 45 hours of continuing education (at least 22 specific to clinical-research regulation/policy) plus a self-administered Continuing Competence Learning Module |
| Governing framework referenced | National/regional regulatory law and guidance (e.g. FDA regulations, ICH quality and submission guidance) for the product's full lifecycle | ICH E6 Good Clinical Practice and the ICH E8(R1)/E9 trial-conduct framework, as applied at the site/sponsor level |
| Where the two overlap | Regulatory affairs staff who also need working GCP literacy to support trial-related submissions | Trial staff who move into regulatory submission work over a career often add RAC rather than replacing CCRP |
Common questions
FAQ
Do I need both RAC and CCRP?+
Not usually. They certify different functions. Someone running trial visits, consenting participants, and managing site documentation is the CCRP (or an ACRP equivalent) audience. Someone assembling a regulatory submission, managing labeling compliance, or advising on approval strategy across a product's lifecycle is the RAC audience. Professionals who move from trial conduct into regulatory affairs over their career sometimes hold both, but most roles only call for one.
Is RAC harder to qualify for than CCRP?+
The eligibility bar is structured differently rather than simply harder or easier. RAC's pathway is built around a sliding scale of formal education plus regulatory experience (down to zero degree requirement with 10 years of experience). CCRP's most common pathway is experience-based with no degree requirement at all, provided the work was full-time clinical-research experience under GCP on an approved protocol.
Is CCRP the same as ACRP's CCRC or CCRA?+
No. CCRP is SOCRA's single generalist credential covering both coordinator- and associate-type experience under one exam. ACRP instead splits certification into separate CCRC (coordinator), CCRA (associate/monitor), and CPI (investigator) exams. See the dedicated ACRP vs. SOCRA comparison for that distinction -- RAC does not compete with either; it sits in the separate regulatory affairs function, not trial-conduct staffing.
Does the FDA or ICH require RAC or CCRP?+
No. Neither the FDA nor the ICH guidelines name RAC or CCRP as a mandatory credential. Both are voluntary professional certifications; individual sponsors, CROs, employers, and sites decide independently whether to require or prefer either one.
