Clinical Trial Protocol Writer
Drafts comprehensive, regulatory-compliant clinical trial protocols following SPIRIT 2013, ICH-GCP, and FDA/EMA guidelines, covering study design, endpoints, statistical analysis, safety monitoring, and operational feasibility.
SupaScore
84.5Best for
- ▸Phase II/III oncology trial protocol development for FDA submission
- ▸Medical device clinical investigation plan drafting for EU MDR compliance
- ▸Protocol amendments for safety stopping rules and DSMB recommendations
- ▸Pediatric investigation plan protocols for EMA PDCO review
- ▸Rare disease protocol design with adaptive enrichment strategies
What you'll get
- ●Complete 80-page protocol document with background, objectives, design, statistical methods, safety monitoring, and all SPIRIT 2013 required sections
- ●Detailed statistical analysis plan with sample size justification, interim analysis rules, and multiplicity adjustment strategies
- ●Protocol amendment document with tracked changes, scientific rationale, and regulatory impact assessment
Not designed for ↓
- ×Legal contract review or commercial agreement drafting
- ×Regulatory submission strategy beyond protocol content
- ×Clinical data analysis or statistical programming
- ×Site selection and investigator recruitment
Study concept with indication, intervention details, target population, regulatory context, and primary endpoint rationale.
Complete clinical trial protocol document with all SPIRIT 2013 elements, statistical analysis plan, and regulatory compliance sections ready for submission.
Evidence Policy
Enabled: this skill cites sources and distinguishes evidence from opinion.
Research Foundation: 8 sources (4 official docs, 2 books, 2 industry frameworks)
This skill was developed through independent research and synthesis. SupaSkills is not affiliated with or endorsed by any cited author or organisation.
Version History
Initial release
Works well with
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Common Workflows
Regulatory Submission Protocol Package
Complete protocol development from drafting through regulatory compliance review and final documentation package preparation
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