🎓 Clinical Data Management Certification Programs

Offered by Qtech-Sol Professional Development Center

🔹 Introduction

Clinical Data Management (CDM) is a critical function in clinical research that ensures the integrity, accuracy, and reliability of trial data. As trials grow in complexity, there is a rising need for trained professionals who can manage electronic data capture systems, perform quality control, and prepare datasets for regulatory submission.

Qtech-Sol offers structured certification programs tailored for entry-level students, career changers, and professionals looking to advance in the field of data-driven clinical research.

🌟 Best-Fit Program Finder

At Qtech-Sol Professional Development Center, we know every learner’s journey is unique. That’s why we’ve built this Best-Fit Program Finder to match your education, experience, and career goals with the right training program.

Whether you’re a student, career changer, or working professional, our tool helps you quickly discover the program best suited to your background.

🔹 Option A — Manual Filters
Select your Education Major, Level, Experience, Student Category, and Domain from the dropdowns, then click Show Programs to see your best-fit training options.

🔹 Option B — Resume Parse
Paste or upload your resume (Word/PDF), and our AI parser will extract your details to recommend the most relevant programs. Click Parse & Recommend to view suggestions.

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🔹 Available Certification Programs

1. Introduction to Clinical Data Management (CDM) (Intro — Essentials)

  • Level: Essentials (All levels)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • CDM lifecycle, stakeholders, and data flow (CRF → DB → listings)
    • Core systems overview: EDC, ePRO/eCOA, CTMS, safety interfaces
    • Data standards basics (CDASH, SDTM overview)
    • Roles & responsibilities across CDM/CRA/Stats/Reg
    • Quality, compliance, and audit trail fundamentals
  • Format: LMS lessons, quizzes, orientation tasks

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2. Basics of Clinical Trial Phases & Role of CDM (CT-Phases — Orientation)

  • Level: Essentials (Entry & cross-functional)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • Phases I–IV, designs, endpoints, controls
    • Where CDM fits: start-up → maintenance → lock
    • Randomization/blinding concepts & implications for data
    • SAE/PV interfaces, data privacy, ALCOA+
    • Terminology map & cross-functional touchpoints
  • Format: LMS lessons, phase-map exercises, quizzes

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3. Case Report Form (CRF) / eCRF Basics (CRF — Foundations)

  • Level: Essentials–Intermediate (CRF designers/CRCs/CDM)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • CRF design principles (CRF completion guidelines, UAT basics)
    • CDASH/SDTM-aware field design (domains & variable mapping)
    • Edit check strategy embedded in CRF design
    • Common pitfalls: protocol vs CRF mismatches
    • Change control & versioning practices
  • Format: LMS lessons, CRF labs, review checklists

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4. Fundamentals of Data Validation & Edit Checks (EditChecks — Core)

  • Level: Essentials–Intermediate (CDM programmers/validators)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • Edit check taxonomy (hard/soft, cross-form, range, plausibility)
    • Query rules, derivations, and data cleaning strategy
    • Risk-based data review & KRI alignment
    • Specification writing and traceability to protocol/CRF
    • UAT, defect tracking, and release management
  • Format: LMS lessons, spec-writing labs, UAT drills

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5. Data Entry, Query Management & Discrepancy Resolution (DataEntry — Operations)

  • Level: Essentials–Intermediate (Site/CDM operations)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • Source → EDC data entry standards & best practices
    • Query lifecycle: creation, assignment, reconciliation, closure
    • Discrepancy review meetings and escalation paths
    • Metrics & dashboards for data cleaning performance
    • Email etiquette & audit-ready correspondence logs
  • Format: LMS lessons, workflow labs, correspondence templates

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6. Clinical Data Assistant (CDAA — Support Level)

  • Level: Support-level (Diploma, BSc)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Intake & triage of EDC discrepancies
    • CRF/eCRF checks, missing data follow-ups, data entry QC
    • Basic MedDRA/WHO-DD awareness & PV handoffs
    • Tracking logs (discrepancy, change, metrics) & filing basics
    • Communication follow-ups & status reporting
  • Format: LMS lessons, guided labs, quick checks

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7. Clinical Data Manager (CDMT — Core Role)

  • Level: Intermediate (BSc/MSc/BSN/PharmD)
  • Duration: 8 weeks / 180 hours
  • Curriculum:
    • Study start-up: CRF finalization, edit-check specs, UAT coordination
    • Ongoing data review, reconciliation (SAE, lab, AE/CM), protocol deviations
    • Coding oversight, mid-study updates, amendment control
    • DB lock readiness: clean file, DCFs, open query burn-down
    • Vendor oversight & metrics/KPIs for study health
  • Format: LMS lessons, case sims, reconciliation labs

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8. Database Lock & Unlock (DBL — Readiness)

  • Level: Intermediate (CDM/Leads/CRAs)
  • Duration: 2 weeks / 40 hours
  • Curriculum:
    • DBL checklist & milestone gating (FPI/LPI → lock)
    • Late-entry handling, freeze/lock procedures, unlock governance
    • SAE reconciliation finalization & coding closure
    • Data review listings, clean-file criteria & sign-offs
    • Inspection-ready documentation & partner alignment
  • Format: LMS lessons, checklists, readiness drills

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9. Lead Clinical Data Manager (LeadCDM — Leadership)

  • Level: Advanced (Experienced CDM/Leads)
  • Duration: 10 weeks / 220 hours
  • Curriculum:
    • Portfolio/study leadership: planning, timelines, risk registers
    • Cross-functional governance (Biostats, PV, Reg, TMF, Programming)
    • KRIs/KPIs dashboards; quality by design (QbD) in CDM
    • Vendor oversight (EDC build, labs, eCOA/ePRO), change control
    • Lessons learned, CAPA effectiveness, team mentoring
  • Format: LMS lessons, leadership sims, capstone project

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10. Audit & Inspection Readiness (CDM) (AuditCDM — Compliance)

  • Level: Intermediate–Advanced (3+ yrs / Leads)
  • Duration: 3 weeks / 60 hours
  • Curriculum:
    • SOP/PSMF alignment (CDM scope) & inspection logistics
    • Storyboards, mock interviews, and document marshaling
    • Common findings in CDM & remediation strategies
    • Partner/vendor oversight evidence & audit trails
    • CAPA drafting, effectiveness checks, and close-out
  • Format: LMS lessons, mock audits, readiness drills

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11. AI in Clinical Data Management (AI-CDM — Modern Practice)

  • Level: Intermediate–Advanced (Data-savvy CDM/Leads)
  • Duration: 4 weeks / 90 hours
  • Curriculum:
    • AI/ML use-cases: anomaly detection, RBM/RBQM signals, eTMF analytics
    • NLP for discrepancy narratives & protocol deviation patterns
    • Assisted edit-check proposals & auto-coding suggestions
    • Governance: data integrity, bias, explainability, and validation
    • Building an AI adoption plan (pilot → scale)
  • Format: LMS lessons, tool demos, mini-projects

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🛠️ Learning Features & Support

  • Self-paced access via Qtech AI-LMS
  • Simulated EDC environments and validation checklists
  • Mock tasks for CRF annotation, DMP writing, and data discrepancy resolution
  • Final exam and Certificate of Completion
  • Optional Resume Marketing Services (RMS): Resume prep, job search, mock interviews

✅ Why Join Qtech-Sol?

  • ✔️ Job-ready training for CDM, clinical data analyst, and regulatory data roles
  • ✔️ Simulations using EDC, MedDRA/WHODrug, and ICH guidelines
  • ✔️ RMS services to connect with CROs, pharma, and hospital data teams
  • ✔️ Flexible format for students, working professionals, and career switchers

🔜 Next Steps