Protocols handling and management

# 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.

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# 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 the actual protocol-defined reference event for each visit.

Support:
- Calendar-day calculations.
- Business-day calculations where explicitly required.
- Inclusive and exclusive date rules.
- Visit windows expressed as plus/minus days.
- Different reference dates for different visits.
- Unscheduled visits.
- Early termination visits.
- Rescheduled visits.

Show the calculation logic and source reference.

Provide a warning when a scheduled visit falls outside the approved window.

Never silently change a reference date or assume a visit window.

Include a calendar view and subject-specific visit timeline.

# 8. SUBJECT MANAGEMENT

Create a comprehensive subject management module.

Each subject record should include:

- Study-specific subject ID.
- Screening number.
- Enrollment status.
- Randomization status.
- Cohort or treatment group, with appropriate access restrictions.
- Informed consent date.
- Screening date.
- Baseline date.
- Visit history.
- Dosing history.
- Laboratory collection history.
- Safety events.
- Concomitant medications.
- Protocol deviations.
- Pending procedures.
- Diary compliance.
- Follow-up status.
- Withdrawal or completion status.

Provide a chronological subject timeline.

Allow the CRC to see which procedures are required, completed, pending, missed, or not applicable at each visit.

Support multiple subjects within each study.

Use role-based access controls, including separation of blinded and unblinded information.

# 9. STUDY STARTUP AND ACTIVATION MODULE

Build a complete startup tracker.

Include tasks such as:

- Feasibility questionnaires.
- Confidentiality agreements.
- Site selection.
- Site qualification visit.
- Clinical trial agreements.
- Budget negotiations.
- IRB submission.
- IRB approval.
- FDA Form 1572.
- Investigator CVs.
- Medical licenses.
- Financial disclosures.
- GCP training.
- IATA training.
- Delegation of Authority Log.
- Training logs.
- Laboratory certifications.
- Normal laboratory ranges.
- Pharmacy documentation.
- Equipment calibration.
- Temperature logs.
- IP accountability preparation.
- IRT access.
- EDC access.
- CTMS access.
- EPRO access.
- Vendor access.
- Site initiation visit.
- Activation confirmation.

Allow assignment of an owner, due date, completion date, status, and supporting document.

Include a readiness dashboard.

# 10. REGULATORY DOCUMENT MANAGEMENT

Create an electronic regulatory binder organization system.

Organize documents into categories:

- Investigator documents.
- IRB/IEC documents.
- Protocols and amendments.
- Informed Consent Forms.
- Delegation logs.
- Training records.
- Financial disclosures.
- Safety documents.
- Laboratory documents.
- Pharmacy documents.
- Monitoring reports.
- Correspondence.
- Essential documents.
- Study closure documents.

Features:

- Document version tracking.
- Expiration date tracking.
- Missing document alerts.
- Review and approval status.
- Document owner.
- Upload date.
- Effective date.
- Expiration date.
- Filing category.
- Audit history.

Include an essential document completeness dashboard.

Do not represent this module as a validated electronic Trial Master File or regulatory e-signature system unless those capabilities are actually implemented and validated.

# 11. LABORATORY AND SPECIMEN MANAGEMENT

Build a laboratory operations module based on the study laboratory manual.

Extract:

- Required specimen types.
- Tube types.
- Collection volumes.
- Collection time points.
- Processing instructions.
- Centrifugation requirements.
- Temperature requirements.
- Storage requirements.
- Shipping conditions.
- Stability periods.
- Shipment deadlines.
- Laboratory kits.
- Central laboratory requirements.
- Local laboratory requirements.

Create visit-specific laboratory checklists.

Include sample tracking:

- Subject ID.
- Visit.
- Sample type.
- Collection date/time.
- Processing date/time.
- Processing status.
- Shipment date.
- Tracking number.
- Laboratory receipt status.
- Sample i

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