100%
WHO/CIOMS ComplianceFull alignment with CIOMS 2016 7 ethical standards & 41 criteria
4-Stage
Research SubtypesClinical Trials, Non-Clinical, Animal Testing (3R), and Community Social
24-Hour
Workload GuardAutomated cooldown prevents reviewer fatigue and conflict of interest
6 Roles
Granular RBACAdmin, Chairman, Vice Chair, Secretariat, Reviewer, and Researcher
10 Berkas
Attachment VerificationProposal, informed consent, instruments, budget, CV, and bank slips
A4 DomPDF
Official CertificationInstant tamper-evident Ethical Clearance PDF with dynamic QR verification
The Operational Mandate
Context & High-Stakes Constraints
The Faculty of Medicine at Universitas Muhammadiyah Jakarta (FK UMJ) required an end-to-end digital platform to replace manual paperwork and legacy tools in managing research ethics reviews.
Developed over a four-month contract, the system modernizes the ethical clearance lifecycle while enforcing compliance with WHO/CIOMS 2016 and Indonesian national KEPPKN guidelines.
02ENTERPRISE ETHICS INTERFACES
The KEPK FK UMJ Governance System in Action
A complete walkthrough of the KEPK FK UMJ system: multi-subtype protocol submission, administrative completeness audit, workload-guarded reviewer assignment, and chapter-by-chapter AJAX evaluation.
🔒kepk.fkkumj.ac.id
01 / 05Official Client Contract & Platform Architecture
Official Platform Architecture & Overview
Platform architecture overview illustrating the end-to-end WHO/CIOMS 2016 ethical clearance lifecycle and automated PDF issuance.
◆ WHO / CIOMS 2016 & KEPPKN Standards Compliance◆ Service Layer Pattern & Dynamic Subtype Resolver◆ Automated A4 Ethical Clearance PDF Generator
03CAPABILITIES & WORKFLOW
4 Architectural Pillars & Core Capabilities
Built to automate mission-critical operations — unifying domain workflows, core services, and interactive user experiences.
Dynamic Subtype Strategy Pattern
Uses Strategy Resolver to route Clinical, Non-Clinical, Animal, and Social protocols to specialized validation pipelines.
Draft Mode & Relational Integrity
Allows progressive form saving with nullable fields, protected by MySQL transactions and 24 backed medical enums.
Chapter-by-Chapter AJAX Evaluation
Enables ethics reviewers to score and critique individual protocol sections asynchronously without page reloads.
Institutional Reviewer Guardrails
Enforces a 24-hour assignment cooldown and a minimum 3-reviewer quorum for high-risk Full Board studies.
4 Core Governance & Review Modules
A standardized academic research ethics platform managing protocol drafting, administrative triage, reviewer appointment, and tamper-evident certification.
MODULE // 01 OF 04Submission Engine
Researcher Portal & 3-Stage Protocol Wizard
Self-service protocol submission portal with progressive draft saving and specialized medical forms.
- Progressive Draft Mode: Researchers can pause and resume lengthy submissions without validation blockers.
- 4 Specialized Subtypes: Dynamically serves tailored Form B modules: Clinical, Non-Clinical, Animal Testing (3R), and Social Research.
- WHO/CIOMS Self-Assessment: 41-question checklist mapped directly to the 7 international CIOMS 2016 ethical standards.
5-Stage WHO/CIOMS Ethical Clearance Governance Lifecycle
End-to-end medical research governance workflow enforcing 24-hour reviewer workload cooldowns, multi-stage audits, and automated A4 DomPDF certification.
Stage 01Lead Researcher
3-Stage Protocol Submission & Self-Assessment
Researchers complete subtype-specific protocol questionnaires, upload 10 mandatory supporting dossiers, and finish 41-question WHO/CIOMS self-assessments.
Multi-Step Form Wizard & Draft Submission
Stage 02Ethics Secretariat
Administrative Completeness Verification
Secretariat staff review submitted files, consent forms, and administrative vouchers to certify dossiers as Verified or return for revision.
Administrative Audit & Completeness Certification
Stage 03Secretariat & Leadership
Path Classification & Reviewer Appointment
Protocols are classified into Exempted, Expedited, or Full Board paths, followed by reviewer assignments governed by a 24-hour workload guard.
Risk Pathway Triaging & Reviewer Quorum Guard
Stage 04Ethics Reviewers
Chapter-by-Chapter Asynchronous Review
Reviewers independently evaluate protocol chapters via AJAX, submitting scores and qualitative notes before rendering an ethical verdict.
Asynchronous Section Scoring & Ethical Recommendation
Stage 05Ethics Committee Chairman
Final Clearance Seal & DomPDF Generation
Committee leadership issues executive sign-off, automatically generating official A4 DomPDF Ethical Clearance certificates with verification QR codes.
Executive Seal & Automated Certificate Generation
24-Hour Reviewer Workload Guard & Plenary Quorum Lockout
The system enforces an automated 24-hour assignment lockout for active reviewers and requires a mandatory minimum of 3 reviewers for Full Board plenary protocols.
04SYSTEM ANATOMY & ARCHITECTURE
System Architecture & Modular Topology
Engineered for high availability, fault tolerance, and clear domain separation across frontend interfaces, service layers, and data stores.
Pattern: Service-Layer Clean Architecture (MVC)
Protocol: RESTful HTTP & AJAX Endpoints (CSRF & Fortify Secured)
Frontend UI Layer
Blade + Tailwind CSS v4 + Vite 7Fast, responsive user interface styled with Tailwind CSS v4 and @tailwindcss/vite, featuring SweetAlert2 interactive modals and Axios asynchronous protocol chapter updates.
HTTP & Authorization Layer
Fortify 2FA + Spatie RBAC 6.21Secure entry point with 16-digit NIK registration, two-factor authentication (2FA), and dynamic role-based access control governing 6 distinct institutional personas.
Service & Domain Layer
Service Layer + Strategy ResolverDecoupled business logic via BaseResearchCreationService and subtype-specific handlers (Clinical, NonClinical, Animal, Social), strictly typed with 24 medical backed enums.
Persistence & Data Layer
MySQL 8.x + MariaDB + EloquentStructured relational database schema with JSON column attributes, foreign key cascades, soft deletes, and atomic DB transactions ensuring zero protocol corruption.
Export & Reporting Engine
Barryvdh DomPDF + Maatwebsite ExcelAutomated server-side rendering for official A4 Ethical Clearance PDF certificates with verification QR codes and batch administrative spreadsheet exports.
Curated Technology Stack
A modern engineering stack combining high-throughput user interfaces, modular backend architecture, and resilient data layers.
Backend Core & Framework
Laravel 12.xModern PHP MVC Framework
PHP 8.2+Typed Server-Side Language Engine
Eloquent ORMActive Record & Relational Data Layer
Service Layer PatternDecoupled Business Logic Architecture
Strategy ResolverDynamic Subtype Request & Service Mapping
24 Backed EnumsMedical-Grade Type Safety & State Enums
Database & Security
MySQL 8.x / MariaDBRelational Database with JSON Attributes
Laravel Fortify 1.3016-Digit NIK Auth, Sessions & 2FA
Spatie Permission 6.216-Tier RBAC & Granular Permissions
DB TransactionsAtomic Multi-Table Submission Safety
CSRF & SQL Injection GuardsBuilt-in Framework Perimeter Security
Frontend Styling & Interactivity
Tailwind CSS v4High-Performance Modern CSS Framework
@tailwindcss/viteInstant Vite Compilation Plugin
Blade TemplatingServer-Rendered UI with View Composers
SweetAlert2 11.23Interactive Dialogs & Decision Confirmations
AxiosAJAX Chapter Review Submissions
Vite 7.xLightning-Fast Asset Bundling
Document Generation & DevOps
Barryvdh DomPDF 3.1Official A4 Ethical Clearance PDF Generator
Maatwebsite Excel 3.1Administrative Spreadsheet Export Engine
Pest PHP 4.0 & PHPUnitComprehensive Unit & Feature Testing
Laravel PintPHP Code Style Standardization
Laravel Debugbar & PailQuery Performance & Real-Time Logging
AWS Cloud InfrastructureProduction Cloud Hosting & Storage
Codebase Structure & Data Models
Clear boundary separation between system components, paired with modular schemas and structured repositories.
📁 kepk-backend/ (Laravel 12.x Architecture)
├──app/Services/ResearchCreation/ — BaseResearchCreationService & Subtype Services
├──app/Services/ResearchCreation/ResearchSubtypeResolver.php — Dynamic Strategy Resolver
├──app/Http/Controllers/ — VerifyController, PathClassificationController, AppointmentReviewerController
├──app/Http/Controllers/ReviewTaskController.php — AJAX chapter evaluation & comments
├──app/Http/Controllers/PostApproval/ — Amendment, FinalReport, EthicsExtension, SaeReport
├──app/Http/Requests/Store/ — BaseStoreResearchRequest & subtype draft-mode validation
├──app/Enums/ — 24 medical backed enums (ClinicalTrialPhase, VulnerableType, TriState, Sponsor)
├──app/View/Composers/RoleComposer.php — Zero-cost view injection for RBAC navigation
├──database/migrations/ — Relational schema, JSON attributes, foreign keys cascade
Medical Ethics Protocol & Review Schema Models
researches & research_protocols
Master study protocols, WHO/CIOMS self-assessment scores, multi-stage draft states, and investigator metadata.
form_b_clinical / non_clinical / animal / social
Specialized medical data tables: Belmont ethical principles, clinical trial phases I-IV, 3R animal welfare, and community consent protocols.
review_tasks & chapter_reviews
Secretariat reviewer assignments, 24-hour cooldown timestamps, chapter-by-chapter status/comment records, and ethical decisions.
research_corrections & revisions
Interactive revision matrix storing researcher response notes, document upload revisions, and resubmission tracking.
post_approval_governance (amendments, sae, extensions)
Audited post-clearance modules: protocol amendments, serious adverse event (SAE) incident alerts, annual renewals, and final reports.
05SECURITY, API & PRODUCTION IMPACT
Hardened Perimeter & Proven Impact
Enterprise-grade security policies, documented API contracts, and the quantifiable outcomes achieved during production deployment.
API Endpoints & Routing Architecture
Authentication & Identity (/auth)
POST/register16-digit NIK researcher self-registration via Laravel Fortify
POST/loginSession-based authenticated access with rate limiting
POST/user/two-factor-authenticationTwo-Factor Authentication (2FA) toggle & secret generation
Protocol Submission & Wizard (/research)
GET/research/createMulti-stage protocol submission wizard (Form A, B, C, D, E)
POST/research/store-draftSave progressive protocol draft without strict validation constraints
POST/research/storeFull validation submission triggering dynamic Subtype Resolver
POST/research/{id}/attachmentsUpload & categorize 10 mandatory supporting files
POST/research/{id}/self-assessmentStore 41-question WHO/CIOMS 7-standard evaluation scores
Secretariat Audit & Classification (/secretariat)
POST/verify/{id}/completenessApprove completeness or issue completeness_revision status
POST/path-classification/{id}Classify protocol into Exempted, Expedited, or Full Board
POST/appointment-reviewer/{id}Assign reviewers with 24-hour cooldown & Full Board quorum validation
Reviewer Tasks & Decisions (/reviewer)
GET/review-task/{id}Interactive chapter-by-chapter evaluation console
POST/review-task/{id}/chapter-reviewAJAX submission of chapter score and qualitative comments
POST/review-task/{id}/decisionSubmit final verdict: Approved (Layak Etik), Revision, or Rejected
Certification & Post-Approval (/post-approval)
GET/research/{id}/export-pdfGenerate tamper-evident A4 DomPDF Ethical Clearance Certificate
POST/research-amendment/{id}Submit protocol amendment proposal with alteration rationale
POST/research-ethics-extension/{id}Apply for 12-month ethical clearance validity renewal
POST/research-sae/{id}/reportFile urgent Serious Adverse Event (SAE) clinical trial alert
POST/research-final-report/{id}Submit final study dossier for ethical archival closure
Enterprise Security & Governance Standards
Laravel Fortify 16-Digit NIK & 2FA
Enforces strict Indonesian National Identification Number (NIK) formatting upon user registration paired with Fortify two-factor authentication for sensitive review actions.
Spatie Role-Based Access Control (RBAC)
Defines 6 granular system roles with strict policy gates, ensuring complete segregation of duties between researchers, secretariat staff, and ethics reviewers.
Atomic Database Transactions
All multi-step protocol submissions, file attachments, and reviewer appointments execute inside DB transactions to guarantee zero partial data corruption.
Parameterized ORM & Anti-CSRF Armor
Eloquent ORM prepared statements eliminate SQL injection vulnerabilities, while Laravel CSRF tokens safeguard all form requests and asynchronous Axios AJAX dispatches.
Engineering Challenges & Production Results
How critical technical bottlenecks were overcome and verified under real production conditions.