임상시험 관리 플랫폼 설계 및 개발

# MASTER PRODUCT DEVELOPMENT PROMPT
## Clinical Research Command Center (CRCC)
### An AI-Powered Clinical Trial Operations and Management Platform

Act as a senior software architect, full-stack developer, clinical research operations specialist, clinical trial project manager, regulatory affairs specialist, and AI product designer.

Your assignment is to design and build a complete, professional, secure, web-based application called:

**CLINICAL RESEARCH COMMAND CENTER (CRCC)**

This application is intended for a Clinical Research Coordinator who serves as the primary coordinator and operational lead for clinical trials and is responsible for overseeing study conduct, coordinating site activities, maintaining protocol compliance, managing subjects, supporting the Principal Investigator, coordinating study teams, and ensuring inspection readiness.

This must be a functional software application, not merely a visual dashboard or static prototype.

The application should consolidate the major operational responsibilities of a Clinical Research Coordinator into one centralized platform.

---

# 1. CORE PRODUCT OBJECTIVE

Build a centralized clinical research management system that allows me to:

- Manage multiple clinical trials simultaneously.
- Organize all protocol documents and study-related materials.
- Extract and interpret protocol requirements using AI.
- Convert the Schedule of Activities (SoA) into structured visit plans.
- Automatically calculate subject visit dates and allowable visit windows.
- Track subjects throughout their participation.
- Manage study startup and activation activities.
- Track regulatory documents and essential documents.
- Manage laboratory and sample processing requirements.
- Monitor AE and SAE reporting requirements.
- Generate professional draft progress notes and study documentation.
- Track protocol deviations and corrective/preventive actions.
- Prepare for monitoring visits and audits.
- Monitor enrollment, retention, compliance, and operational performance.
- Identify upcoming deadlines, overdue activities, and potential compliance risks.

The application must be designed around the workflow of a lead CRC who is accountable for coordinating daily site operations.

# 2. APPLICATION DESIGN AND USER EXPERIENCE

Create a modern, professional clinical research software interface.

Design characteristics:

- Clean, enterprise-grade dashboard.
- Professional medical and clinical research aesthetic.
- White and light-gray backgrounds.
- Sage green, forest green, and muted teal accents.
- Minimalistic icons.
- Organized side navigation.
- Responsive desktop and tablet layouts.
- Searchable tables, filters, and interactive calendars.
- Clear status indicators.
- Notification center.
- Global search.
- User activity history.

The application should feel like a professional clinical trial management platform, not a generic AI chatbot.

Use a modular architecture so additional features can be incorporated later.

# 3. MAIN DASHBOARD

Create a central dashboard with the following sections:

**Study Overview**
- Total active studies.
- Studies in startup.
- Studies actively enrolling.
- Studies in follow-up.
- Studies closed to enrollment.
- Studies in closeout.

**Subject Overview**
- Total screened subjects.
- Screen failures.
- Enrolled subjects.
- Randomized subjects.
- Active subjects.
- Completed subjects.
- Withdrawn subjects.
- Subjects lost to follow-up.

**Operational Dashboard**
- Upcoming subject visits.
- Visits approaching their scheduling windows.
- Overdue visits.
- Missing eDiary entries.
- Pending laboratory results.
- Pending data queries.
- Outstanding documentation.
- Pending AE/SAE follow-up.
- Open protocol deviations.
- Pending regulatory documents.

**Notifications and Alerts**
- Upcoming deadlines.
- Expiring certifications.
- Protocol amendments requiring implementation.
- Overdue activities.
- Missing essential documents.
- Subject visits outside allowable windows.

Allow filtering by study and date range.

# 4. STUDY MANAGEMENT MODULE

Create a dedicated workspace for each clinical trial.

Each study must have:

- Study title.
- Protocol number.
- Sponsor.
- CRO.
- Principal Investigator.
- Sub-Investigators.
- Study coordinator.
- Study team members.
- Therapeutic area.
- Study phase.
- Study design.
- Enrollment target.
- Enrollment cap.
- Study status.
- Site number.
- IRB/IEC information.
- Current protocol version.
- Protocol effective date.
- Study activation date.
- Enrollment opening date.
- Enrollment closure date.
- Study completion date.

Allow multiple studies to be managed independently.

Each study must have its own documents, subjects, visit schedules, regulatory records, laboratory requirements, and operational dashboard.

# 5. AI PROTOCOL INTELLIGENCE ENGINE

This is one of the most important components.

Allow uploading:

- Clinical study protocols.
- Protocol amendments.
- Schedule of Activities.
- Investigator Brochures.
- Laboratory manuals.
- Pharmacy manuals.
- Study-specific manuals.
- Informed Consent Forms.
- Study reference guides.
- Monitoring plans.
- Data management plans.
- Study newsletters.
- Sponsor communications.
- Other study-related documents.

Supported file formats:
- PDF.
- DOCX.
- XLSX.
- CSV.
- PPTX.

The AI engine must read and organize the documents by study and document type.

Extract and organize:

1. Study objectives.
2. Study design.
3. Inclusion criteria.
4. Exclusion criteria.
5. Screening requirements.
6. Randomization requirements.
7. Dosing requirements.
8. Visit schedules.
9. Visit windows.
10. Required procedures.
11. Laboratory assessments.
12. Specimen collection requirements.
13. Safety reporting requirements.
14. Contraception requirements.
15. Prohibited medications.
16. Concomitant medication requirements.
17. Subject diary requirements.
18. Follow-up requirements.
19. Study completion criteria.
20. Early termination requirements.

Every extracted requirement must have:

- Source document.
- Protocol version.
- Section number.
- Page number.
- Exact supporting passage or table reference.
- Extraction confidence.
- Review status.

The AI must never invent protocol requirements.

If information is unclear, missing, contradictory, or unavailable, clearly flag it for human review.

When amendments are uploaded, compare them against the previous version and identify changes affecting eligibility, procedures, visit windows, safety, laboratories, and study conduct.

Maintain a version-controlled protocol knowledge base.

# 6. SCHEDULE OF ACTIVITIES (SoA) BUILDER

Develop a sophisticated SoA extraction and management module.

Automatically identify:

- Visit names.
- Study days.
- Visit numbers.
- Visit windows.
- Screening periods.
- Baseline assessments.
- Procedures.
- Laboratory tests.
- Questionnaires.
- Safety assessments.
- Dosing activities.
- Follow-up activities.
- Optional procedures.
- Conditional procedures.
- Assessments that apply only to specific cohorts.

Convert the extracted information into a structured, interactive SoA table.

Allow the CRC to:

- Review extracted procedures.
- Edit incorrect extractions.
- Approve requirements.
- Add notes.
- Identify conditional requirements.
- Compare protocol versions.
- Export the approved SoA into Excel or PDF.

Each visit must have its own detailed procedure checklist.

Never assume that every procedure occurs at every visit.

# 7. AUTOMATED VISIT CALCULATOR

Develop a protocol-driven visit scheduling engine.

This feature must allow me to enter:

- Subject ID.
- Screening date.
- Informed consent date.
- Baseline date.
- Randomization date.
- First dose date.
- Other protocol-defined reference dates.

Automatically calculate:

- Target visit dates.
- Earliest allowable visit dates.
- Latest allowable visit dates.
- Visit windows.
- Follow-up dates.
- Laboratory collection time points.
- Safety follow-up dates.
- Study completion dates.

IMPORTANT:

The calculation engine must use

• 활용실제 앱 구현 시 원하는 기술 스택(React, Python 등)을 프롬프트 하단에 추가하세요.
• 활용AI 문서 분석 기능 성능을 위해 RAG 시스템 구현에 필요한 지침을 보완하면 좋습니다.

출처 · prompts.chat · Protocols handling and management — 원문은 출처에 게시된 그대로이며, 권리는 원작자에게 있습니다.

웹 화면(HTML) 결과

Gemini로 프롬프트를 실행해 생성한 화면입니다. 화면 안에서 직접 조작하실 수 있습니다.

# MASTER PRODUCT DEVELOPMENT PROMPT
## Clinical Research Command Center (CRCC)
### An AI-Powered Clinical Trial Operations and Management Platform

Act as a senior software architect, full-stack developer, clinical research operations specialist, clinical trial project manager, regulatory affairs specialist, and AI product designer.

Your assignment is to design and build a complete, professional, secure, web-based application called:

**CLINICAL RESEARCH COMMAND CENTER (CRCC)**

This application is intended for a Clinical Research Coordinator who serves as the primary coordinator and operational lead for clinical trials and is responsible for overseeing study conduct, coordinating site activities, maintaining protocol compliance, managing subjects, supporting the Principal Investigator, coordinating study teams, and ensuring inspection readiness.

This must be a functional software application, not merely a visual dashboard or static prototype.

The application should consolidate the major operational responsibilities of a Clinical Research Coordinator into one centralized platform.

---

# 1. CORE PRODUCT OBJECTIVE

Build a centralized clinical research management system that allows me to:

- Manage multiple clinical trials simultaneously.
- Organize all protocol documents and study-related materials.
- Extract and interpret protocol requirements using AI.
- Convert the Schedule of Activities (SoA) into structured visit plans.
- Automatically calculate subject visit dates and allowable visit windows.
- Track subjects throughout their participation.
- Manage study startup and activation activities.
- Track regulatory documents and essential documents.
- Manage laboratory and sample processing requirements.
- Monitor AE and SAE reporting requirements.
- Generate professional draft progress notes and study documentation.
- Track protocol deviations and corrective/preventive actions.
- Prepare for monitoring visits and audits.
- Monitor enrollment, retention, compliance, and operational performance.
- Identify upcoming deadlines, overdue activities, and potential compliance risks.

The application must be designed around the workflow of a lead CRC who is accountable for coordinating daily site operations.

# 2. APPLICATION DESIGN AND USER EXPERIENCE

Create a modern, professional clinical research software interface.

Design characteristics:

- Clean, enterprise-grade dashboard.
- Professional medical and clinical research aesthetic.
- White and light-gray backgrounds.
- Sage green, forest green, and muted teal accents.
- Minimalistic icons.
- Organized side navigation.
- Responsive desktop and tablet layouts.
- Searchable tables, filters, and interactive calendars.
- Clear status indicators.
- Notification center.
- Global search.
- User activity history.

The application should feel like a professional clinical trial management platform, not a generic AI chatbot.

Use a modular architecture so additional features can be incorporated later.

# 3. MAIN DASHBOARD

Create a central dashboard with the following sections:

**Study Overview**
- Total active studies: 12
- Studies in startup: 3
- Studies actively enrolling: 5
- Studies in follow-up: 2
- Studies closed to enrollment: 1
- Studies in closeout: 1

**Subject Overview**
- Total screened subjects: 145
- Screen failures: 28
- Enrolled subjects: 117
- Randomized subjects: 102
- Active subjects: 88
- Completed subjects: 10
- Withdrawn subjects: 4
- Subjects lost to follow-up: 0

**Operational Dashboard**
- Upcoming subject visits: 8
- Visits approaching their scheduling windows: 12
- Overdue visits: 1
- Missing eDiary entries: 5
- Pending laboratory results: 14
- Pending data queries: 22
- Outstanding documentation: 9
- Pending AE/SAE follow-up: 2
- Open protocol deviations: 3
- Pending regulatory documents: 6

**Notifications and Alerts**
- Upcoming deadlines.
- Expiring certifications.
- Protocol amendments requiring implementation.
- Overdue activities.
- Missing essential do

텍스트 결과

Gemini로 실행한 결과입니다. 입력 항목에는 국내 환경의 예시값을 적용했습니다(AI 생성 — 사실 확인 필요).

# MASTER PRODUCT DEVELOPMENT PROMPT
## Clinical Research Command Center (CRCC)
### An AI-Powered Clinical Trial Operations and Management Platform

Act as a senior software architect, full-stack developer, clinical research operations specialist, clinical trial project manager, regulatory affairs specialist, and AI product designer.

Your assignment is to design and build a complete, professional, secure, web-based application called:

**CLINICAL RESEARCH COMMAND CENTER (CRCC)**

This application is intended for a Clinical Research Coordinator who serves as the primary coordinator and operational lead for clinical trials and is responsible for overseeing study conduct, coordinating site activities, maintaining protocol compliance, managing subjects, supporting the Principal Investigator, coordinating study teams, and ensuring inspection readiness.

This must be a functional software application, not merely a visual dashboard or static prototype.

The application should consolidate the major operational responsibilities of a Clinical Research Coordinator into one centralized platform.

---

# 1. CORE PRODUCT OBJECTIVE

Build a centralized clinical research management system that allows me to:

- Manage multiple clinical trials simultaneously.
- Organize all protocol documents and study-related materials.
- Extract and interpret protocol requirements using AI.
- Convert the Schedule of Activities (SoA) into structured visit plans.
- Automatically calculate subject visit dates and allowable visit windows.
- Track subjects throughout their participation.
- Manage study startup and activation activities.
- Track regulatory documents and essential documents.
- Manage laboratory and sample processing requirements.
- Monitor AE and SAE reporting requirements.
- Generate professional draft progress notes and study documentation.
- Track protocol deviations and corrective/preventive actions.
- Prepare for monitoring visits and audits.
- Monitor enrollment, retention, compliance, and operational performance.
- Identify upcoming deadlines, overdue activities, and potential compliance risks.

The application must be designed around the workflow of a lead CRC who is accountable for coordinating daily site operations.

# 2. APPLICATION DESIGN AND USER EXPERIENCE

Create a modern, professional clinical research software interface.

Design characteristics:

- Clean, enterprise-grade dashboard.
- Professional medical and clinical research aesthetic.
- White and light-gray backgrounds.
- Sage green, forest green, and muted teal accents.
- Minimalistic icons.
- Organized side navigation.
- Responsive desktop and tablet layouts.
- Searchable tables, filters, and interactive calendars.
- Clear status indicators.
- Notification center.
- Global search.
- User activity history.

The application should feel like a professional clinical trial management platform, not a generic AI chatbot.

Use a modular architecture so additional features can be incorporated later.

# 3. MAIN DASHBOARD

Create a central dashboard with the following sections:

**Study Overview**
- Total active studies: 12
- Studies in startup: 3
- Studies actively enrolling: 5
- Studies in follow-up: 2
- Studies closed to enrollment: 1
- Studies in closeout: 1

**Subject Overview**
- Total screened subjects: 145
- Screen failures: 28
- Enrolled subjects: 117
- Randomized subjects: 102
- Active subjects: 88
- Completed subjects: 10
- Withdrawn subjects: 4
- Subjects lost to follow-up: 0

**Operational Dashboard**
- Upcoming subject visits: 8
- Visits approaching their scheduling windows: 12
- Overdue visits: 1
- Missing eDiary entries: 5
- Pending laboratory results: 14
- Pending data queries: 22
- Outstanding documentation: 9
- Pending AE/SAE follow-up: 2
- Open protocol deviations: 3
- Pending regulatory documents: 6

**Notifications and Alerts**
- Upcoming deadlines.
- Expiring certifications.
- Protocol amendments requiring implementation.
- Overdue activities.
- Missing essential do

개선안

원문과 같은 언어로 보완한 프롬프트입니다. 점수는 명확성 · 구체성 · 출력 형식 · 재사용성 기준의 AI 평가입니다.

# MASTER PRODUCT DEVELOPMENT PROMPT: CLINICAL RESEARCH COMMAND CENTER (CRCC)

## 1. ROLE & SYSTEM CONTEXT
Act as a Senior Software Architect, Full-Stack Developer, Clinical Research Operations Specialist, and AI Product Designer. You are tasked with designing and writing the complete production-grade architecture and core code implementation for a web-based platform: **Clinical Research Command Center (CRCC)**.

Target Stack / Preferences: [Insert Tech Stack, e.g., React/Next.js, Python/FastAPI, PostgreSQL, Tailwind CSS].

## 2. CORE PRODUCT OBJECTIVE & TARGET USER
Design an enterprise-grade, modular clinical research management system for a Lead Clinical Research Coordinator (CRC). The application consolidates multi-trial management, AI protocol extraction, Schedule of Activities (SoA) building, automated visit window calculations, subject tracking, regulatory compliance, and audit readiness into a single centralized web platform.

## 3. KEY MODULE SPECIFICATIONS

### A. Main Dashboard & UX
- **Aesthetic**: Enterprise medical look (white/light-gray background, sage green/forest green/muted teal accents, clean minimal icons).
- **Components**: Multi-study KPI cards (Startup, Enrolling, Follow-up, Closed), Subject status breakdown, Operational action items (overdue visits, data queries, pending AE/SAE), and real-time Notification Center.

### B. Study Management Workspace
- Manage independent clinical trial workspaces tracking protocol metadata (Protocol #, Sponsor, PI, Phase, Site #, IRB details, effective dates, targets).

### C. AI Protocol Intelligence Engine
- **Document Parsing**: Support PDF, DOCX, XLSX, CSV, PPTX for Protocols, Amendments, SoA, Lab Manuals, ICFs.
- **Extraction Targets**: 20 core fields (Eligibility criteria, visit schedules, dosing, safety/SAE rules, prohibited meds, lab specs).
- **Traceability Constraint**: Every extracted rule must include `source_document`, `version`, `section`, `page_number`, `exact_quote`, and `confidence_score`. Flag ambiguities for human review. Never hallucinate rules.
- **Amendment Diffing**: Compare protocol versions and highlight operational changes.

### D. Schedule of Activities (SoA) Builder
- Convert protocol SoAs into interactive visit-by-procedure matrices with review, edit, approval, and PDF/Excel export capabilities.

### E. Automated Visit Calculator Engine
- Compute target dates, allowable windows (min/max days), follow-up windows, and lab collection points based on reference dates (Consent, Baseline, Randomization, First Dose).
- **Handling Logic**: Account for leap years, protocol-defined business vs. calendar days, and overlapping visit window alerts.

## 4. EXECUTION & OUTPUT REQUIREMENTS
Provide a comprehensive, production-ready specification and code implementation structured as follows:
1. **System Architecture Diagram & Module Breakdown** (Component hierarchy & data flow).
2. **Database Schema Design** (SQL/Prisma schemas for Studies, Protocols, Subjects, Visits, SoA Items, and Audit Logs).
3. **AI Extraction Prompt & Logic Specifications** (Structured JSON output schemas for protocol extraction).
4. **Core Business Logic Code** (Algorithm for automated visit date and window calculations with edge-case handling).
5. **Frontend Dashboard UI Code** (Main overview dashboard component with search, filtering, and alert indicators).

## 5. SELF-REVIEW & QUALITY CONSTRAINTS
- Ensure zero placeholders in critical calculation logic.
- Enforce strict data isolation between multiple studies.
- Verify all AI-extracted items maintain lineage/citation data.