Postgraduate Diploma in Efficacy Validation and Controlled Studies
Online 800-hour Postgraduate Diploma in Efficacy Validation and Controlled Studies. 8 modules covering ICH E6(R3) (good clinical practice), ICH E9 (statistical principles for clinical trials) and R. Assigned tutor and open enrolment.
Take the controls.
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
Formulate efficacy questions and select the appropriate study design.
Compare parallel, crossover, factorial and non-inferiority controlled designs.
Apply randomisation and masking techniques to control bias.
Calculate the sample size and statistical power of a trial.
Plan the statistical analysis by intention to treat and per protocol.
Integrate ethical, quality and regulatory requirements into study design.
Draft the full protocol of a controlled trial.
Who it's for
- Clinical researcher who wants to specialise in Efficacy Validation and Controlled Studies.
- Biostatistician who wants to specialise in Efficacy Validation and Controlled Studies.
- Clinical trial monitor who wants to specialise in Efficacy Validation and Controlled Studies.
- Study coordinator who wants to specialise in Efficacy Validation and Controlled Studies.
- Regulatory affairs technician who wants to specialise in Efficacy Validation and Controlled Studies.
- Clinical research project manager who wants to specialise in Efficacy Validation and Controlled Studies.
- Graduates in engineering or sciences seeking to enter the pharmaceutical industry.
What you'll work with
- ICH E6(R3) (good clinical practice)
- ICH E9 (statistical principles for clinical trials)
- ICH E10 (choice of control group)
- Regulation (EU) 536/2014 (clinical trials with medicinal products)
- ISO 14155 (clinical investigation of medical devices)
- Declaration of Helsinki
- CONSORT 2010
8 modules · 800 h
1.1Hierarchy of evidence1.2Efficacy versus effectiveness1.3PICO research question1.4Superiority, non-inferiority and equivalence1.5Primary and secondary endpoints1.6Surrogate variables and their validity1.7Explanatory and pragmatic trials: PRECIS-21.8Clinical development phases1.9Prospective trial registration1.10Workshop: PICO formulation and hypotheses
2.1Two-arm parallel trial2.2Crossover design and washout period2.3Two-intervention factorial design2.4Cluster trials2.5Stepped-wedge design2.6Adaptive designs with prespecified rules2.7N-of-1 trials in individual patients2.8Simulated controls in devices2.9Multi-arm platform trials2.10Case study: choosing a design for a digital therapy
3.1Simple and block randomisation3.2Stratified randomisation by prognostic factors3.3Minimisation and dynamic allocation3.4Allocation concealment3.5Masking in non-pharmacological interventions3.6Blinded outcome assessors3.7Placebos and digital controls3.8Assessment of masking success3.9IWRS randomisation systems3.10Practical: randomisation list in R
4.1Type I and II errors4.2Effect size and minimal important difference4.3Calculation for means and proportions4.4Calculation for time-to-event outcomes4.5Adjustment for loss to follow-up4.6Intraclass correlation coefficient4.7Multiplicity of comparisons4.8Non-inferiority margins4.9Simulation for complex designs4.10Practical: calculation with G*Power and R
5.1Intention-to-treat and per-protocol analysis5.2Estimands according to ICH E9(R1)5.3ANCOVA with baseline measurement5.4Linear mixed models5.5Multiple imputation of missing data5.6Sensitivity analysis5.7Subgroup analysis5.8Interim analyses and stopping rules5.9Bayesian approaches in trials5.10Laboratory: analysis of a simulated trial in R
6.1Declaration of Helsinki6.2ICH E6(R3) Good Clinical Practice6.3Regulation (EU) 536/2014 on clinical trials6.4Research ethics committees for medicinal products6.5Informed consent of participants6.6Risk-based monitoring6.7Data monitoring committee (DSMB)6.8Reporting of adverse events6.9Data management and electronic CRF6.10Case study: review of a protocol by the CEIm
7.1CONSORT statement and extensions7.2Risk of bias with RoB 27.3Certainty of evidence with GRADE7.4Meta-analysis of controlled trials7.5Detecting spin in results7.6Publication bias7.7Publication of negative results7.8Sharing individual participant data7.9Plain language for patients7.10Workshop: appraisal of a published trial with RoB 2
8.1Rationale and research question8.2Design and population8.3Intervention and comparator8.4Outcomes and visit schedule8.5Randomisation and masking8.6Sample size calculation8.7Statistical analysis plan8.8Ethical and regulatory aspects8.9Report and presentation8.10Final review with the tutor
How you'll learn
100 % online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: students progress at their own pace within the intake, which makes it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is R, SAS, Stata, nQuery, REDCap, in free, academic or evaluation versions. Trials are studied through real procedures for drafting a controlled trial protocol, calculating sample size and power, and critically appraising published trials. Assessment is continuous by module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Formulate efficacy questions and select the appropriate study design.
Compare parallel, crossover, factorial and non-inferiority controlled designs.
Apply randomisation and masking techniques to control bias.
Calculate the sample size and statistical power of a trial.
Plan the statistical analysis by intention to treat and per protocol.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient level of Spanish to follow technical regulatory texts.
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 consists of 800 hours in total, spread over 6 to 8 months. That is an average of 10 to 15 hours per week, compatible with full-time work.
The programme works with R, SAS, Stata, nQuery, REDCap. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM own diploma upon passing the continuous assessment and the final integrating project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the advanced programme. Check the recognition policy when you enrol.
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