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.
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Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply good clinical practice in trials with medicinal products and devices.
Design clinical studies with appropriate estimands and sample sizes.
Manage clinical investigations in accordance with ISO 14155 and the MDR.
Implement validated clinical data management systems.
Prepare clinical and performance evaluations of medical devices.
Audit clinical processes and manage corrective actions.
Integrate real-world evidence into health technology assessment.
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.
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
12 modules · 1900 h
1.1History of clinical trial regulation1.2Ethical principles and the Declaration of Helsinki1.3ICH E6(R3) good clinical practice1.4Roles: sponsor, investigator and CRO1.5Quality systems in clinical trials1.6Risk-based quality management1.7Study quality indicators1.8Quality culture and deviations1.9Data integrity in the trial1.10Case study: analysis of a GCP inspection
2.1Clinical questions and ICH E9(R1) estimands2.2Randomised controlled trials2.3Crossover and factorial designs2.4Non-inferiority trials2.5Adaptive and Bayesian designs2.6Sample size calculation2.7Randomisation and blinding2.8Outcome variables and endpoints2.9Pragmatic trials and the PRECIS-2 tool2.10Practical exercise: sample size calculation for non-inferiority
3.1ISO 14155 good practice3.2MDR requirements for clinical investigations3.3Clinical investigation plan3.4Investigator's brochure3.5Feasibility and pivotal studies3.6Device learning curve3.7Reporting of serious adverse events3.8PMCF investigations with CE-marked devices3.9Differences from medicinal product trials3.10Workshop: investigation plan for a class IIb device
4.1Regulation (EU) 536/2014 and the coordinated procedure4.2Submission and assessment through CTIS4.3Spanish Royal Decree 1090/20154.4Ethics committees for research with medicinal products4.5Insurance and liability4.6Informed consent and participant information sheet4.7Minors and vulnerable populations in trials4.8Coordination of multinational trials4.9Transparency and registration4.10Practical exercise: informed consent documentation
5.1Site selection and activation5.2Monitoring visits5.3Centralised and remote monitoring5.4Source data verification5.5Management of protocol deviations5.6Trial master file (TMF)5.7Investigational product management5.8Site close-out5.9Oversight of CROs and vendors5.10Case study: risk-based monitoring plan
6.1Electronic case report forms6.2CDISC CDASH and SDTM standards6.3Data validation and cleaning6.4Coding with MedDRA6.5Validated systems and 21 CFR Part 116.6Device and wearable data6.7Database lock6.8Data audits6.9Security and privacy6.10Laboratory: designing an eCRF and its validation plan
7.1Descriptive and inferential statistics7.2Hypothesis testing and errors7.3Confidence intervals7.4Survival analysis7.5Regression models7.6Interim analyses and data monitoring committees7.7Control of multiple comparisons7.8Handling missing data and imputation7.9Writing the statistical analysis plan7.10Practical exercise: survival analysis with R
8.1Clinical evaluation plan under the MDR8.2MDCG 2020-5 on equivalence8.3Systematic literature search protocol8.4Appraisal of clinical data8.5State of the art and benefit-risk8.6Writing the CER8.7PMCF and its plan8.8MDCG 2020-6 on sufficient clinical evidence8.9Update frequency by device class8.10Workshop: searching and appraising clinical literature
9.1IVDR requirements for performance evaluation9.2Scientific validity of the analyte9.3Analytical sensitivity and specificity9.4Clinical sensitivity, specificity and predictive values9.5Performance studies9.6Performance evaluation report9.7Post-market performance follow-up9.8Performance of IVD software9.9Companion diagnostics and EMA consultation9.10Case study: performance evaluation of a rapid test
10.1ISO 13485 and clinical processes10.2Site and vendor audits10.3Regulatory authority inspections10.4CAPA management in research10.5Quality of central laboratories10.6Calibration and study equipment10.7Document management of clinical procedures10.8Staff training10.9Audit metrics10.10Practical exercise: simulated audit of an investigator site
11.1Patient registries11.2Observational studies with secondary data11.3Health record data11.4Health technology assessment11.5Regulation (EU) 2021/2282 on HTA11.6Cost-effectiveness analysis and QALYs11.7Patient-reported outcomes11.8Decentralised trials and remote visits11.9Publication of results11.10Case study: designing an implant registry
12.1Product and clinical question12.2Evidence strategy12.3Clinical study design12.4Quality management plan12.5Data management plan12.6Statistical analysis plan12.7Clinical or performance evaluation12.8Post-market follow-up plan12.9Thesis report12.10Master's Thesis: defence before a panel
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.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
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.
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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