Apply root cause analysis to adverse events involving clinical trial data quality.
Managing Clinical Trial Data and Ensuring Its Quality
A senior-level treatment of clinical trial data quality, focused on what changes outcomes.
📍 Istanbul🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Variation in clinical trial data quality between shifts and sites is where avoidable harm lives. Clinical staff will work around a process for data quality that obstructs care, and they will be right to. Teams frequently over-invest in documenting this area of health and pharmaceutical services and under-invest in testing it. The programme converts clinical trial data quality from an area of general awareness into a set of repeatable practices. Organisations that document the wider health and pharmaceutical services agenda properly resolve disputes about it far more quickly. Participants come from operational and oversight roles, and both perspectives on data quality are used deliberately. Participants finish able to explain clinical trial data quality to a non-specialist audience without losing precision. The teaching approach is deliberately practical: participants build a clinical protocol for data quality as they go. It ends with a prioritised list of changes to this strand of health and pharmaceutical services that the participant is prepared to defend internally.
Expected Learning Outcomes
Distinguish the parts of data quality that must be standardised from those that require judgement.
Plan staffing and rota cover appropriate to demand in clinical trial data quality.
Align data quality with the wider objectives of the clinical service rather than optimising it in isolation.
Design medication and treatment safety controls within clinical trial data quality.
Identify the failure points in data quality most likely to cause loss, and control them first.
Build continuing professional development sustaining competence in clinical trial data quality.
Who Should Attend
Clinical department heads responsible for clinical trial data quality.
Supply chain and biomedical staff supporting data quality.
Accreditation and compliance officers preparing evidence on clinical trial data quality.
Nursing managers and clinical supervisors delivering data quality.
Anyone whose accountability for clinical trial data quality exceeds their current formal training in it.
Compliance and governance staff whose remit includes data quality.
Course Modules
Clinical trial data quality: clinical process design and workflow
2 sessions · 8 pointsSession 1The decisions in clinical trial data quality that cannot be delegated
- Check that consent processes within clinical trial data quality are genuinely informed.
- Assemble the accreditation evidence pack for data quality.
- Confirm patient data handled within clinical trial data quality meets confidentiality obligations.
- Close out actions on data quality rather than leaving them open indefinitely.
Session 2Consent, confidentiality and ethics in data quality
- Cost clinical trial data quality per episode and identify avoidable waste.
- Identify where judgement in data quality is legitimate and where it is not.
- Confirm that contractual obligations around clinical trial data quality are understood.
- Define escalation criteria for deterioration detected through data quality.
Data quality: staffing, capacity and demand
2 sessions · 8 pointsSession 1Investigating an adverse event involving data quality
- Establish who is informed, consulted and accountable in clinical trial data quality.
- Select quality indicators for data quality that measure outcome rather than activity.
- Name a single owner for each element of clinical trial data quality.
- Build the competence framework that supports data quality.
Session 2Choosing indicators for data quality that reflect outcome
- Apply structured root cause analysis to the last adverse event involving clinical trial data quality.
- Distinguish symptoms from causes when data quality underperforms.
- Confirm that reporting on clinical trial data quality reaches the people who can act.
- Verify cold chain and storage conditions for materials used in data quality.
Data quality: infection prevention and patient safety
2 sessions · 8 pointsSession 1What has to be agreed before work on data quality starts
- Map the handovers in clinical trial data quality between functions and secure them.
- Draft the minimum viable clinical protocol for data quality.
- Audit clinical trial data quality by observing practice, not by reading policy.
- Close the loop: confirm changes to data quality improved the indicator they targeted.
Session 2The evidence assessors will ask for on clinical trial data quality
- Build medication safety checks into clinical trial data quality at the point of highest risk.
- Reduce unwarranted variation in data quality between shifts and sites.
- Plan continuity of clinical trial data quality during surge and outbreak conditions.
- Confirm competence and continuing development for staff delivering data quality.
Data quality: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1Designing data quality so it helps rather than obstructs care
- Set the review interval for clinical trial data quality and who attends.
- Compare the cost of data quality with the cost of its absence.
- Measure patient experience of clinical trial data quality and feed it back to the team.
- Set out how exceptions to data quality are requested and approved.
Session 2Reading the current state of data quality honestly
- Agree what will be standardised in clinical trial data quality and what will not.
- Identify infection transmission risks created by data quality and control them.
- Test the procedure for clinical trial data quality against a realistic scenario.
- Establish what evidence demonstrates data quality is under control.
Choose the package that suits you
Silver Package
At least 3 people
USD1,250
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Gold Package
At least 3 people
USD1,850
- 5-night stay in a 5-star hotel
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Complete your registration
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