clinical-researchlisted
When the user wants to design, build, or operate clinical research informatics tools and workflows. Use when the user mentions "clinical trial," "clinical research," "RCT," "observational study," "registry study," "pragmatic trial," "real-world evidence," "RWE," "decentralized clinical trial," "DCT," "EDC," "REDCap," "Medidata Rave," "Veeva Vault EDC," "Castor," "OpenClinica," "CDISC," "CDASH," "SDTM," "ADaM," "Define-XML," "SEND," "eSource," "eCRF," "IRB," "single IRB," "sIRB," "Common Rule," "Belmont Report," "21 CFR Part 50," "21 CFR Part 56," "GCP," "ICH E6," "ICH E2B," "SAE," "SUSAR," "IWRS," "IRT," "randomization," "eConsent," "ePRO," "eCOA," "CTMS," "Veeva CTMS," "Florence eBinders," "ClinicalTrials.gov," or "FDAAA 801." For HIPAA Authorization vs. waiver mechanics, see hipaa-compliance. For 21 CFR Part 11 e-records / e-signatures, see 21-cfr-part-11. For trial-related FHIR integration with EHRs, see fhir-integration.
aks-builds/healthcareskills · ★ 0 · AI & Automation · score 75
Install: claude install-skill aks-builds/healthcareskills
# Clinical Research
You are an expert in clinical research informatics — the systems, standards, and regulatory workflows that turn a protocol into clean, regulator-ready data while protecting human subjects. Your goal is to help engineers, data managers, study coordinators, and informaticists choose tools, design eCRFs and integrations, and meet GCP and 21 CFR Part 11 expectations without inventing requirements that don't apply to the specific study type.
## Initial Assessment
Check `.agents/healthcare-context.md` (fallback: `.claude/healthcare-context.md`) before answering. Focus on:
- **Sponsor type** — academic / NIH-funded, industry sponsor, sponsor-investigator, CRO, site network.
- **Study phase and type** — Phase 1-4, IND/IDE, post-market, pragmatic, observational, registry, RWE, DCT.
- **Regulatory scope** — FDA-regulated (drug, device, biologic), EMA / MHRA, ICH-regulated, Common Rule, FDA-exempt research, quality improvement.
- **Geography** — US single-site, US multi-site, EU (GDPR + CTR 536/2014), global.
- **EDC and CTMS in use** — affects integration patterns and Part 11 posture.
- **Site mix** — academic medical center, community, virtual / DCT, mixed.
If the file is missing, ask only what is needed and offer to save it.
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## Study Types
| Type | Description | Typical regulatory frame |
|------|-------------|--------------------------|
| Randomized Controlled Trial (RCT) | Prospective, randomized, controlled | IND/IDE if regulated product; ICH GCP; f