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Master’s in Quality, Clinical Trials and Clinical Evaluation Engineering

Online master's programme of 1,900 hours in quality, clinical trials and clinical evaluation engineering. 12 modules covering GCP quality, trial design, device clinical investigations, the regulatory framework, monitoring, clinical data management, biostatistics, MDR clinical evaluation, IVD performance evaluation, audits and real-world evidence, with an assigned technical tutor.

Duration1900 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Apply good clinical practice in trials with medicinal products and devices.

02

Design clinical studies with appropriate estimands and sample sizes.

03

Manage clinical investigations in accordance with ISO 14155 and the MDR.

04

Implement validated clinical data management systems.

05

Prepare clinical and performance evaluations of medical devices.

06

Audit clinical processes and manage corrective actions.

07

Integrate real-world evidence into health technology assessment.

Profile

Who it's for

  • Clinical research associates (trial monitors).
  • Clinical research quality managers.
  • Medical device clinical evaluation specialists.
  • Clinical data managers.
  • Biostatisticians.
  • GCP auditors.
  • Engineering or science graduates looking to enter the pharmaceutical industry.
Standards & tools

What you'll work with

  • ICH E6(R3) (good clinical practice)
  • ISO 14155 (clinical investigation of medical devices)
  • Regulation (EU) 536/2014 (clinical trials)
  • Regulation (EU) 2017/745 (medical devices)
  • Regulation (EU) 2017/746 (in vitro diagnostic medical devices)
  • ICH E9(R1) (estimands and sensitivity analysis)
  • MDCG 2020-5 (clinical equivalence)
  • Royal Decree 1090/2015 (Spanish regulation on clinical trials with medicinal products)
  • R
  • SAS
  • REDCap
  • Medidata Rave
  • OpenClinica
Syllabus

12 modules · 1900 h

  1. 1.1History of clinical trial regulation
  2. 1.2Ethical principles and the Declaration of Helsinki
  3. 1.3ICH E6(R3) good clinical practice
  4. 1.4Roles: sponsor, investigator and CRO
  5. 1.5Quality systems in clinical trials
  6. 1.6Risk-based quality management
  7. 1.7Study quality indicators
  8. 1.8Quality culture and deviations
  9. 1.9Data integrity in the trial
  10. 1.10Case study: analysis of a GCP inspection
  1. 2.1Clinical questions and ICH E9(R1) estimands
  2. 2.2Randomised controlled trials
  3. 2.3Crossover and factorial designs
  4. 2.4Non-inferiority trials
  5. 2.5Adaptive and Bayesian designs
  6. 2.6Sample size calculation
  7. 2.7Randomisation and blinding
  8. 2.8Outcome variables and endpoints
  9. 2.9Pragmatic trials and the PRECIS-2 tool
  10. 2.10Practical exercise: sample size calculation for non-inferiority
  1. 3.1ISO 14155 good practice
  2. 3.2MDR requirements for clinical investigations
  3. 3.3Clinical investigation plan
  4. 3.4Investigator's brochure
  5. 3.5Feasibility and pivotal studies
  6. 3.6Device learning curve
  7. 3.7Reporting of serious adverse events
  8. 3.8PMCF investigations with CE-marked devices
  9. 3.9Differences from medicinal product trials
  10. 3.10Workshop: investigation plan for a class IIb device
  1. 4.1Regulation (EU) 536/2014 and the coordinated procedure
  2. 4.2Submission and assessment through CTIS
  3. 4.3Spanish Royal Decree 1090/2015
  4. 4.4Ethics committees for research with medicinal products
  5. 4.5Insurance and liability
  6. 4.6Informed consent and participant information sheet
  7. 4.7Minors and vulnerable populations in trials
  8. 4.8Coordination of multinational trials
  9. 4.9Transparency and registration
  10. 4.10Practical exercise: informed consent documentation
  1. 5.1Site selection and activation
  2. 5.2Monitoring visits
  3. 5.3Centralised and remote monitoring
  4. 5.4Source data verification
  5. 5.5Management of protocol deviations
  6. 5.6Trial master file (TMF)
  7. 5.7Investigational product management
  8. 5.8Site close-out
  9. 5.9Oversight of CROs and vendors
  10. 5.10Case study: risk-based monitoring plan
  1. 6.1Electronic case report forms
  2. 6.2CDISC CDASH and SDTM standards
  3. 6.3Data validation and cleaning
  4. 6.4Coding with MedDRA
  5. 6.5Validated systems and 21 CFR Part 11
  6. 6.6Device and wearable data
  7. 6.7Database lock
  8. 6.8Data audits
  9. 6.9Security and privacy
  10. 6.10Laboratory: designing an eCRF and its validation plan
  1. 7.1Descriptive and inferential statistics
  2. 7.2Hypothesis testing and errors
  3. 7.3Confidence intervals
  4. 7.4Survival analysis
  5. 7.5Regression models
  6. 7.6Interim analyses and data monitoring committees
  7. 7.7Control of multiple comparisons
  8. 7.8Handling missing data and imputation
  9. 7.9Writing the statistical analysis plan
  10. 7.10Practical exercise: survival analysis with R
  1. 8.1Clinical evaluation plan under the MDR
  2. 8.2MDCG 2020-5 on equivalence
  3. 8.3Systematic literature search protocol
  4. 8.4Appraisal of clinical data
  5. 8.5State of the art and benefit-risk
  6. 8.6Writing the CER
  7. 8.7PMCF and its plan
  8. 8.8MDCG 2020-6 on sufficient clinical evidence
  9. 8.9Update frequency by device class
  10. 8.10Workshop: searching and appraising clinical literature
  1. 9.1IVDR requirements for performance evaluation
  2. 9.2Scientific validity of the analyte
  3. 9.3Analytical sensitivity and specificity
  4. 9.4Clinical sensitivity, specificity and predictive values
  5. 9.5Performance studies
  6. 9.6Performance evaluation report
  7. 9.7Post-market performance follow-up
  8. 9.8Performance of IVD software
  9. 9.9Companion diagnostics and EMA consultation
  10. 9.10Case study: performance evaluation of a rapid test
  1. 10.1ISO 13485 and clinical processes
  2. 10.2Site and vendor audits
  3. 10.3Regulatory authority inspections
  4. 10.4CAPA management in research
  5. 10.5Quality of central laboratories
  6. 10.6Calibration and study equipment
  7. 10.7Document management of clinical procedures
  8. 10.8Staff training
  9. 10.9Audit metrics
  10. 10.10Practical exercise: simulated audit of an investigator site
  1. 11.1Patient registries
  2. 11.2Observational studies with secondary data
  3. 11.3Health record data
  4. 11.4Health technology assessment
  5. 11.5Regulation (EU) 2021/2282 on HTA
  6. 11.6Cost-effectiveness analysis and QALYs
  7. 11.7Patient-reported outcomes
  8. 11.8Decentralised trials and remote visits
  9. 11.9Publication of results
  10. 11.10Case study: designing an implant registry
  1. 12.1Product and clinical question
  2. 12.2Evidence strategy
  3. 12.3Clinical study design
  4. 12.4Quality management plan
  5. 12.5Data management plan
  6. 12.6Statistical analysis plan
  7. 12.7Clinical or performance evaluation
  8. 12.8Post-market follow-up plan
  9. 12.9Thesis report
  10. 12.10Master's Thesis: defence before a panel
Methodology, software & labs

How you'll learn

Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so the programme is compatible with full-time work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is R, SAS, REDCap, Medidata Rave and OpenClinica, in free, academic or evaluation versions. Work is based on real procedures: design of protocols and clinical evaluation plans, simulated audits of investigator sites and statistical analysis of trial data. Assessment is continuous by module, plus the final Master's Thesis.

Standards covered: ICH E6(R3), ISO 14155, Regulation (EU) 536/2014, Regulation (EU) 2017/745, Regulation (EU) 2017/746, ICH E9(R1), MDCG 2020-5, Royal Decree 1090/2015.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of ICH E6(R3), ISO 14155 and Regulation (EU) 536/2014 applied to real cases, not as a theoretical annex.
Industry software:R, SAS, REDCap, Medidata Rave and OpenClinica, in free, academic or evaluation versions.
Master's Thesis with defence:A complete clinical evidence package for a product, from study design to quality, data and statistical analysis plans, defended before a panel.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Clinical question and evidence strategy
Define the product, the clinical question and the evidence strategy.
Clinical study design
Design the clinical study with its endpoints, estimands and sample size.
Quality and data management
Write the quality management and data management plans.
Statistics and evaluation
Prepare the statistical analysis plan and the clinical or performance evaluation.
Master's Thesis
A complete clinical evidence package with its post-market follow-up plan, defended before a panel.
Career opportunities

Where this takes you

Clinical research associateClinical research quality managerMedical device clinical evaluation specialistClinical data managerBiostatisticianGCP auditor
Admissions & scholarships

Requirements

  • University degree in engineering, science or architecture, or equivalent demonstrable professional experience.
  • Internet connection and a computer capable of running the programme software.
  • English sufficient to read technical standards.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

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FAQ

Frequently asked questions

The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.

You work with R, SAS, REDCap, Medidata Rave and OpenClinica, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.

A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.

Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.

A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the programme software and English sufficient to read technical standards.

Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.

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