1 | Why SOCRA Matters
The SOCRA CCRP is recognized across hospitals, universities, and research centers.
It verifies knowledge in U.S. FDA regulations and ICH GCP ethics.
2 | Eligibility
- Path A: 2 yrs FT clinical research.
- Path B: Health degree + 1 yr research.
- Path C: Research certificate + 1 yr experience.
3 | Exam Overview
- 130 MCQs (100 scored).
- 3 hours.
- Pass score ≈ 70 %.
- Topics: IRB process, CFR, informed consent, AE reporting, protocol deviations.
4 | Study Plan (6 Weeks)
| Week | Focus | Task |
|---|---|---|
| 1 | FDA Regulations | Read 21 CFR Parts 50, 56, 312. |
| 2 | Ethics | Review Belmont Report, ICH E6 sections 2 & 4. |
| 3 | IRB & Consent | Mock questions on participant rights. |
| 4 | AE/SAE | Know reporting windows & sponsor duties. |
| 5 | Data Mgmt | Understand source docs, queries, record retention. |
| 6 | Full Mocks | Take 2 tests + targeted review. |
5 | Exam Tips
- Focus on US vs ICH language differences.
- Know the definition of “minimal risk.”
- Memorize consent elements (21 CFR 50.25).
- Sleep well and hydrate — 3 hours is long!
6 | After Certification
Renew every 3 years (45 CE hrs + $350).
Adds ≈ 8–10 % salary bump and opens doors to CRA roles.