Postgraduate Diploma in DCT Protocols and ePRO Data Capture
Online 800-hour Postgraduate Diploma in DCT protocols and ePRO data capture. 8 modules covering ICH E6(R3) (good clinical practice), Regulation (EU) 536/2014 (clinical trials) and Medidata Rave. Assigned tutor and enrolment open.
Postgraduate Diploma in DCT Protocols and ePRO Data Capture — studying from Malta
Malta's healthcare system relies on public hospitals alongside a growing private sector, creating demand for engineers in medical devices, clinical technology and facilities. The Medicines Authority and the Health Directorate set regulatory expectations that shape work on medical equipment. Biomechanics and wearable technology are emerging interests, particularly in rehabilitation, sports science and occupational safety. Professionals in this area often collaborate with clinicians, distributors and regulators to ensure devices meet national and European requirements.
Fees for Malta: €1,290 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Malta
Typical roles
Questions from Malta
Is this programme recognised by a professional body in Malta for engineers working in health, biomechanics or wearables?
SEIUM Institute's qualifications are its own private qualifications. They are not official Maltese state degrees and are not accredited by any national body. In Malta, engineering titles are regulated through the Malta Council for Professions and the Chamber of Engineers, and medical devices fall under the Medicines Authority. Recognition of a private qualification is decided by employers or the relevant body, so check with them before enrolling.
Will employers in Malta value this training for roles in wearables or operational safety?
Employers in Malta's health technology, manufacturing and safety-related sectors decide for themselves how much weight to give a private online qualification. Many weigh practical experience and a final project heavily. SEIUM's programmes include a final project, but whether it helps your career in Malta depends on your employer's view. Speaking with prospective employers beforehand is the most reliable way to find out.
Can I study this alongside a full-time job in Malta, and is employer funding possible?
The programmes are 100% online and taught in English, so you can study from home without a student visa. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly time accordingly. Fees are payable in instalments, and employer sponsorship is possible. Each student gets an assigned technical tutor for support.
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
Describe decentralised and hybrid clinical trial models.
Design a DCT protocol in line with European regulation.
Plan electronic consent and remote recruitment.
Select validated PRO instruments for the trial objective.
Implement ePRO capture while ensuring measurement equivalence.
Ensure data integrity in line with ALCOA+ principles.
Apply centralised monitoring and PRO data analysis.
Who it's for
- Decentralised clinical trial manager who wants to specialise in DCT Protocols and ePRO Data Capture.
- ePRO/eCOA specialist who wants to specialise in DCT Protocols and ePRO Data Capture.
- Clinical monitor who wants to specialise in DCT Protocols and ePRO Data Capture.
- Clinical data manager who wants to specialise in DCT Protocols and ePRO Data Capture.
- Clinical operations manager who wants to specialise in DCT Protocols and ePRO Data Capture.
- Trial technology consultant who wants to specialise in DCT Protocols and ePRO Data Capture.
- Graduates in engineering or science seeking to enter the pharmaceutical industry.
What you'll work with
- ICH E6(R3) (good clinical practice)
- Regulation (EU) 536/2014 (clinical trials)
- 21 CFR Part 11 (electronic records and signatures)
- EMA/HMA recommendations on decentralised elements in clinical trials (2022)
- ICH E9(R1) (estimands)
- Regulation (EU) 2016/679 (GDPR)
- FDA guidance on patient-reported outcomes (PRO, 2009)
8 modules · 800 h
1.1Definition and DCT models: hybrid and fully remote1.2Advantages for recruitment, retention and diversity1.3Limitations and risks of decentralisation1.4European recommendation on decentralised elements1.5FDA guidance on trials with decentralised elements1.6Roles of the sponsor, investigator and providers1.7Home visits and research nursing1.8Direct shipment of medication to the patient1.9Selection of DCT elements according to the drug1.10Case study: hybrid redesign of a phase III trial
2.1Protocol structure according to ICH E6(R3) and SPIRIT2.2Plan of in-person and remote visits2.3Eligibility criteria compatible with remote participation2.4Selection of variables collected remotely2.5Management of the investigational product at home2.6Risk-based monitoring plan2.7Management of adverse events remotely2.8Amendments and protocol version control2.9Activity schedule and flow diagram2.10Workshop: visit table for a hybrid protocol
3.1Electronic informed consent (eConsent)3.2Verification of participant identity3.3Consent comprehension: multimedia and questionnaires3.4Digital recruitment and social media3.5Online prescreening and patient registries3.6Digital divide and equity of access3.7Requirements of Regulation 536/2014 on trials3.8Approval by the CEIm and the AEMPS3.9Participant retention and engagement3.10Practice: designing an eConsent flow with identity verification
4.1Patient-reported outcomes and their usefulness4.2Development and validation of PRO instruments4.3FDA PRO guidance and the PFDD document4.4Generic instruments: EQ-5D, SF-36 and PROMIS4.5Content validity and cognitive interviews4.6Reliability, responsiveness to change and MCID4.7Cross-cultural adaptation and translation4.8Licences and rights for questionnaires4.9Recall period and measurement frequency4.10Case study: selecting PROs for an arthritis trial
5.1Migration from paper to electronic format5.2Mode equivalence according to ISPOR and C-Path5.3Provisioned devices versus BYOD5.4Screen design and ePRO usability5.5Electronic diaries and completion windows5.6Reminders and compliance alerts5.7Management of missing and late data5.8Accessibility for older patients5.9User acceptance testing (UAT)5.10Laboratory: ePRO diary prototype with window logic
6.1Architecture of eCOA, EDC and IRT platforms6.2Validation of computerised systems according to GAMP 56.321 CFR Part 11 and Annex 11 of GMP6.4ALCOA+ principles of data integrity6.5Audit trail and change control for data6.6Integration of wearables and digital sensors6.7Interoperability with CDISC and the SDTM standard6.8Privacy and international data transfers6.9Cybersecurity of participant devices6.10Practice: review of an ePRO system audit trail
7.1Centralised monitoring and statistics7.2Key risk indicators in DCT7.3ePRO compliance as a quality metric7.4Detection of anomalous data patterns7.5Statistical analysis of PRO variables7.6Handling of missing data and imputation7.7Estimands according to ICH E9(R1)7.8Common inspection findings in DCT7.9Lessons from published decentralised studies7.10Case study: risk monitoring plan for a DCT
8.1Choice of trial indication and population8.2Definition of decentralised elements8.3Design of the visit schedule8.4Selection and justification of PRO instruments8.5Functional specification of the ePRO system8.6Data integrity and validation plan8.7Monitoring and analysis plan8.8Ethical and regulatory assessment of the design8.9Report and presentation8.10Final review with the tutor
How you'll learn
Training 100 % online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the intake, which allows them to combine it with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Medidata Rave, Castor EDC, REDCap, SAS and R, in free, academic or evaluation versions. Trials are studied through real procedures: migration of paper PRO questionnaires to ePRO, pilots of remote visits and drug shipment, and risk-based centralised monitoring. Assessment is continuous per module, plus a final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe decentralised and hybrid clinical trial models.
Design a DCT protocol in line with European regulation.
Plan electronic consent and remote recruitment.
Select validated PRO instruments for the trial objective.
Implement ePRO capture while ensuring measurement equivalence.
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 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 comprises 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.
You will work with Medidata Rave, Castor EDC, REDCap, SAS and R. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
SEIUM's own diploma upon passing the continuous assessment and the integrating project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area can be recognised in the advanced programme. Check the recognition policy when you enrol.
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