Postgraduate Diploma in Data Quality and Remote Verification
Online 800-hour Postgraduate Diploma in Data Quality and Remote Verification. 8 modules covering ICH E6(R3) (good clinical practice), Regulation (EU) 536/2014 on clinical trials and Medidata Rave. 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
Define the data quality attributes in clinical trials.
Manage the lifecycle of clinical data from capture to database lock.
Design risk-based monitoring plans with key risk indicators.
Apply remote source data verification procedures that preserve confidentiality.
Adapt quality controls to decentralised trials and digital sources.
Use statistical techniques to detect anomalies and outliers.
Prepare trial documentation for audits and regulatory inspections.
Who it's for
- Clinical data manager who wants to specialise in Data Quality and Remote Verification.
- Clinical trial monitor who wants to specialise in Data Quality and Remote Verification.
- Risk-based monitoring specialist who wants to specialise in Data Quality and Remote Verification.
- Good clinical practice auditor who wants to specialise in Data Quality and Remote Verification.
- Biostatistician who wants to specialise in Data Quality and Remote Verification.
- Clinical trial quality manager who wants to specialise in Data Quality and Remote Verification.
- Engineering or science graduates seeking to enter the pharmaceutical industry.
What you'll work with
- ICH E6(R3) (good clinical practice)
- Regulation (EU) 536/2014 on clinical trials
- 21 CFR Part 11 (electronic records and signatures)
- ICH E9 (statistical principles for clinical trials)
- ICH E8(R1) (general considerations for clinical trials)
- CDISC SDTM
- Regulation (EU) 2016/679 (GDPR)
8 modules · 800 h
1.1ALCOA+ principles1.2ICH E6(R3) good clinical practice1.3Data integrity and regulatory guidelines1.4Data sources: CRF, ePRO and wearables1.5Clinical data lifecycle1.6Systematic and random errors1.7Roles: sponsor, CRO and investigator1.8Risk-based quality management1.9Quality indicators1.10Case study: data integrity audit in a trial
2.1Data management plan2.2Design of electronic CRFs2.3EDC systems2.4CDISC CDASH and SDTM standards2.5Coding with MedDRA2.6Data validation and queries2.7Reconciliation of external data2.8Database lock2.9Validated systems and 21 CFR Part 112.10Workshop: specification of validation rules
3.1ICH E6 and the risk-based approach3.2Study risk assessment3.3Key risk indicators3.4Quality tolerance limits3.5Centralised monitoring3.6Reduced on-site monitoring3.7Statistical anomaly detection3.8Monitoring plans3.9RBQM tools3.10Practice: defining KRIs for a trial
4.1Source data verification SDV and SDR4.2Remote access to medical records4.3Data protection in remote verification4.4Certified copies4.5Remote monitoring platforms4.6EMA and AEMPS guidance on remote monitoring4.7Comparison of on-site and remote monitoring4.8Deviation management4.9Monitor training4.10Laboratory: simulated remote verification session
5.1Elements of decentralised trials5.2eConsent5.3Telemedicine in trials5.4Home delivery of medication5.5Wearables and digital biomarkers5.6Identity verification5.7Device data quality5.8Regulatory guidance on decentralised trials5.9Participant experience5.10Case study: designing a hybrid trial
6.1Fraud and data fabrication detection6.2Benford's law and digit preferences6.3Outlier analysis by site6.4Between-site variability6.5Missing data and patterns6.6Quality visualisations6.7Tools in R and Python6.8Interpreting signals6.9Corrective actions6.10Workshop: anomaly detection in site data
7.1Sponsor audits7.2Good clinical practice inspections7.3Common integrity findings7.4Audit trails7.5Electronic trial master file eTMF7.6CAPA management7.7Inspection preparation7.8Validation of computerised systems7.9Supplier quality7.10Practice: review of an audit trail
8.1Trial description8.2Risk assessment8.3Data management plan8.4Remote monitoring plan8.5Indicators and thresholds8.6Centralised analysis8.7Audit plan8.8Conclusions8.9Report 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. No fixed timetable: students progress at their own pace within the intake, which makes it possible to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Medidata Rave, REDCap, SAS, R (tidyverse), in free, academic or evaluation versions. Trials are studied using real procedures for centralised trial monitoring, remote source data verification and data quality audits. Assessment is continuous per 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.
Define the data quality attributes in clinical trials.
Manage the lifecycle of clinical data from capture to database lock.
Design risk-based monitoring plans with key risk indicators.
Apply remote source data verification procedures that preserve confidentiality.
Adapt quality controls to decentralised trials and digital sources.
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 between 10 and 15 hours per week on average, compatible with a full-time job.
You work with Medidata Rave, REDCap, SAS, R (tidyverse). Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A 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 are credited towards the higher programme. Check the credit transfer policy when you enrol.
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