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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

Duration800 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

Describe decentralised and hybrid clinical trial models.

02

Design a DCT protocol in line with European regulation.

03

Plan electronic consent and remote recruitment.

04

Select validated PRO instruments for the trial objective.

05

Implement ePRO capture while ensuring measurement equivalence.

06

Ensure data integrity in line with ALCOA+ principles.

07

Apply centralised monitoring and PRO data analysis.

Profile

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.
Standards & tools

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)
Syllabus

8 modules · 800 h

  1. 1.1Definition and DCT models: hybrid and fully remote
  2. 1.2Advantages for recruitment, retention and diversity
  3. 1.3Limitations and risks of decentralisation
  4. 1.4European recommendation on decentralised elements
  5. 1.5FDA guidance on trials with decentralised elements
  6. 1.6Roles of the sponsor, investigator and providers
  7. 1.7Home visits and research nursing
  8. 1.8Direct shipment of medication to the patient
  9. 1.9Selection of DCT elements according to the drug
  10. 1.10Case study: hybrid redesign of a phase III trial
  1. 2.1Protocol structure according to ICH E6(R3) and SPIRIT
  2. 2.2Plan of in-person and remote visits
  3. 2.3Eligibility criteria compatible with remote participation
  4. 2.4Selection of variables collected remotely
  5. 2.5Management of the investigational product at home
  6. 2.6Risk-based monitoring plan
  7. 2.7Management of adverse events remotely
  8. 2.8Amendments and protocol version control
  9. 2.9Activity schedule and flow diagram
  10. 2.10Workshop: visit table for a hybrid protocol
  1. 3.1Electronic informed consent (eConsent)
  2. 3.2Verification of participant identity
  3. 3.3Consent comprehension: multimedia and questionnaires
  4. 3.4Digital recruitment and social media
  5. 3.5Online prescreening and patient registries
  6. 3.6Digital divide and equity of access
  7. 3.7Requirements of Regulation 536/2014 on trials
  8. 3.8Approval by the CEIm and the AEMPS
  9. 3.9Participant retention and engagement
  10. 3.10Practice: designing an eConsent flow with identity verification
  1. 4.1Patient-reported outcomes and their usefulness
  2. 4.2Development and validation of PRO instruments
  3. 4.3FDA PRO guidance and the PFDD document
  4. 4.4Generic instruments: EQ-5D, SF-36 and PROMIS
  5. 4.5Content validity and cognitive interviews
  6. 4.6Reliability, responsiveness to change and MCID
  7. 4.7Cross-cultural adaptation and translation
  8. 4.8Licences and rights for questionnaires
  9. 4.9Recall period and measurement frequency
  10. 4.10Case study: selecting PROs for an arthritis trial
  1. 5.1Migration from paper to electronic format
  2. 5.2Mode equivalence according to ISPOR and C-Path
  3. 5.3Provisioned devices versus BYOD
  4. 5.4Screen design and ePRO usability
  5. 5.5Electronic diaries and completion windows
  6. 5.6Reminders and compliance alerts
  7. 5.7Management of missing and late data
  8. 5.8Accessibility for older patients
  9. 5.9User acceptance testing (UAT)
  10. 5.10Laboratory: ePRO diary prototype with window logic
  1. 6.1Architecture of eCOA, EDC and IRT platforms
  2. 6.2Validation of computerised systems according to GAMP 5
  3. 6.321 CFR Part 11 and Annex 11 of GMP
  4. 6.4ALCOA+ principles of data integrity
  5. 6.5Audit trail and change control for data
  6. 6.6Integration of wearables and digital sensors
  7. 6.7Interoperability with CDISC and the SDTM standard
  8. 6.8Privacy and international data transfers
  9. 6.9Cybersecurity of participant devices
  10. 6.10Practice: review of an ePRO system audit trail
  1. 7.1Centralised monitoring and statistics
  2. 7.2Key risk indicators in DCT
  3. 7.3ePRO compliance as a quality metric
  4. 7.4Detection of anomalous data patterns
  5. 7.5Statistical analysis of PRO variables
  6. 7.6Handling of missing data and imputation
  7. 7.7Estimands according to ICH E9(R1)
  8. 7.8Common inspection findings in DCT
  9. 7.9Lessons from published decentralised studies
  10. 7.10Case study: risk monitoring plan for a DCT
  1. 8.1Choice of trial indication and population
  2. 8.2Definition of decentralised elements
  3. 8.3Design of the visit schedule
  4. 8.4Selection and justification of PRO instruments
  5. 8.5Functional specification of the ePRO system
  6. 8.6Data integrity and validation plan
  7. 8.7Monitoring and analysis plan
  8. 8.8Ethical and regulatory assessment of the design
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

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.

Accreditable laboratories(EN ISO/IEC 17025) with a rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-focused final project:safety case, test plan, compliance dossier and operating limits.
Industry mentorship:lecturers with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, OT cyber, DIH and compliance as core pillars.
Capstone project

Build it end to end

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

Choice of trial indication and population

Describe decentralised and hybrid clinical trial models.

Definition of decentralised elements

Design a DCT protocol in line with European regulation.

Design of the visit schedule

Plan electronic consent and remote recruitment.

Selection and justification of PRO instruments

Select validated PRO instruments for the trial objective.

Functional specification of the ePRO system

Implement ePRO capture while ensuring measurement equivalence.

Career opportunities

Where this takes you

Decentralised clinical trial managerePRO/eCOA specialistClinical monitorClinical data managerClinical operations managerTrial technology consultant
Admissions & scholarships

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.

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FAQ

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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