Postgraduate Diploma in Centre Management, Contracts and Ethics
Online 800-hour Postgraduate Diploma in Centre Management, Contracts and Ethics. 8 modules covering Reglamento (UE) 536/2014 (clinical trials), Real Decreto 1090/2015 (clinical trials and CEIm) and Veeva Vault CTMS. Assigned tutor and open enrolment.
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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
Describe the agents of the clinical research ecosystem.
Select centres using feasibility criteria.
Negotiate clinical study contracts and budgets.
Apply the ethical principles of research involving human beings.
Prepare submissions for research ethics committees.
Plan participant recruitment and retention.
Ensure quality and compliance throughout the study.
Who it's for
- Research site manager looking to specialise in Centre Management, Contracts and Ethics.
- Clinical contracts specialist looking to specialise in Centre Management, Contracts and Ethics.
- Clinical study coordinator looking to specialise in Centre Management, Contracts and Ethics.
- CEIm technical secretary looking to specialise in Centre Management, Contracts and Ethics.
- Study start-up manager looking to specialise in Centre Management, Contracts and Ethics.
- Patient recruitment manager looking to specialise in Centre Management, Contracts and Ethics.
- Engineering or science graduates seeking to enter the pharmaceutical industry.
What you'll work with
- Regulation (EU) 536/2014 (Clinical Trials)
- Royal Decree 1090/2015 (Clinical Trials and CEIm)
- ICH E6(R2) (Good Clinical Practice)
- Declaration of Helsinki
- Law 14/2007 on Biomedical Research
- CIOMS Ethical Guidelines (2016)
- Regulation (EU) 2016/679 (GDPR)
8 modules · 800 h
1.1Agents: sponsor, CRO, centre and investigator1.2Clinical research units in hospitals1.3Foundations and health research institutes1.4Legal framework: Reglamento UE 536/2014 and MDR1.5Real Decreto 1090/2015 on medicinal product trials1.6Real Decreto 192/2023 on medical devices1.7Public and private study funding1.8Research activity indicators1.9Trends: decentralised studies1.10Case study: stakeholder map for a multicentre trial
2.1Feasibility and viability studies2.2Centre selection criteria2.3Qualification of the principal investigator2.4Infrastructure and equipment2.5Recruitment capacity2.6Trial coordination and data managers2.7Managing the centre's workload2.8Relationship between sponsor and centre2.9Centre performance indicators2.10Practice: centre feasibility questionnaire
3.1Structure of the centre contract3.2Contract models and standard clauses3.3Budget and cost breakdown3.4Per-patient and milestone payments3.5Compensation for investigators and participants3.6Intellectual property and publication3.7Confidentiality3.8Insurance and civil liability3.9Managing signature and deadlines3.10Workshop: preparing a study budget
4.1Principles of the Belmont Report4.2Declaration of Helsinki and CIOMS guidelines4.3Valid informed consent4.4Vulnerable populations4.5Conflicts of interest4.6Minimal risk and benefit-risk balance4.7Scientific integrity and misconduct4.8Use of placebo and equipoise4.9Return of results to participants4.10Case study: ethical dilemmas in a paediatric study
5.1Composition and accreditation of CEIm5.2Evaluation of the protocol and documents5.3Single opinion in Spain5.4Timelines and evaluation procedure5.5Assessment of centre suitability5.6Monitoring of approved studies5.7Amendments and notifications5.8Committees for research without medicines5.9Coordination with the AEMPS5.10Practice: simulated evaluation by a CEIm
6.1Recruitment strategies6.2Identifying patients in medical records6.3Advertising and recruitment materials6.4Retention and adherence6.5Diversity and inclusion in studies6.6Involvement of patient associations6.7Expenses and compensation6.8Participant data protection6.9Communication during the study6.10Workshop: recruitment and retention plan
7.1Centre standard operating procedures7.2Investigator site file7.3Sponsor audits7.4Good clinical practice inspections7.5Deviation management7.6Corrective and preventive actions7.7Continuing GCP training7.8Quality indicators7.9Financial management and transparency7.10Case study: preparing a centre for inspection
8.1Study selection8.2Feasibility plan8.3Centre selection8.4Contract and budget draft8.5Ethical documentation8.6Recruitment plan8.7Quality plan8.8Management timeline8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM Institute campus, with downloadable material, recorded classes and assigned technical tutor. No fixed timetable: students progress at their own pace within the intake, making it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Veeva Vault CTMS, REDCap, DocuSign, advanced Excel, in free, academic or evaluation versions. Case studies are based on real procedures for negotiating study contracts, centre feasibility assessments and review of patient information sheets. 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.
Describe the agents of the clinical research ecosystem.
Select centres using feasibility criteria.
Negotiate clinical study contracts and budgets.
Apply the ethical principles of research involving human beings.
Prepare submissions for research ethics committees.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is 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 totals 800 hours 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 Veeva Vault CTMS, REDCap, DocuSign and advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM Institute diploma awarded on passing the continuous assessment and the final integrating project. It is an in-house qualification, not an official Ministry title.
Yes. Modules completed on a Course or Postgraduate Diploma in the same area are transferred to the higher programme. Check the recognition policy when you enrol.
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