Clinical Data Management (CDM) – Entry Level
COURSE DESCRIPTION
Clinical Data Management (CDM) – Entry Level is a foundational training programme designed to introduce participants to the core principles, processes, and tools that underpin high‑quality clinical data management in clinical research. The course provides a structured and practical introduction to how clinical trial data is planned, collected, validated, cleaned, and prepared for statistical analysis in compliance with global regulatory and quality standards.
The programme begins by establishing the role of data management within the clinical research ecosystem, highlighting how CDM contributes to patient safety, data integrity, and the credibility of clinical trial results. Participants will explore the regulatory and ethical framework that governs clinical data handling, including ICH E6 (GCP), ICH E8, ICH E9, 21 CFR Part 11, GDPR, and key industry standards such as CDISC. This foundation ensures learners understand the principles that guide compliant, secure, and high‑quality data practices.
Building on this regulatory context, the course introduces the end‑to‑end data management lifecycle—from protocol review and Case Report Form (CRF) design to database build, data entry, query management, coding, reconciliation, and database lock. Participants will gain insight into how data flows between investigational sites, electronic data capture (EDC) systems, vendors, and sponsors, and how CDM teams collaborate with clinical operations, biostatistics, pharmacovigilance, and medical writing.
A strong practical component is integrated throughout the programme. Learners will work with sample protocols, CRFs, edit check specifications, data validation plans, and mock EDC environments to develop hands‑on familiarity with real‑world CDM tasks. They will practice identifying discrepancies, raising and resolving queries, performing data cleaning activities, and understanding how data quality is monitored and documented.
The course also introduces essential concepts such as medical coding (MedDRA, WHO‑DD), SAE reconciliation, data standards (CDASH, SDTM), and the importance of audit trails and system validation. Participants will learn how CDM supports risk‑based monitoring, ensures traceability, and contributes to the overall reliability of clinical trial outcomes.
By the end of the programme, participants will have a clear understanding of the CDM function, the regulatory expectations that shape it, and the practical skills needed to begin working effectively in an entry‑level data management role. They will be well‑prepared to support data collection, cleaning, and review activities, contribute to high‑quality datasets, and collaborate confidently within cross‑functional clinical research teams.
Key Topics Covered:
- Introduction to Clinical Data Management — Understand the purpose, scope, and importance of CDM in clinical research, including its impact on data integrity and patient safety.
- Regulatory and Ethical Framework — Explore ICH GCP, 21 CFR Part 11, GDPR, and industry standards that govern data handling, privacy, and system compliance.
- CDM Lifecycle and Core Processes — Learn the full sequence of CDM activities: protocol review, CRF design, database build, data entry, validation, query management, coding, reconciliation, and database lock.
- Electronic Data Capture (EDC) Systems — Gain familiarity with EDC platforms, user roles, audit trails, and the principles of system validation and data security.
- CRF and eCRF Design — Understand how well designed CRFs support accurate data collection, reduce errors, and align with study endpoints and protocol requirements.
- Data Validation and Query Management — Learn how edit checks are developed, how discrepancies are identified, and how queries are raised, resolved, and documented.
- Medical Coding — Introduction to MedDRA and WHO Drug coding, coding conventions, and the role of coding in standardising clinical data.
- Data Reconciliation — Understand the reconciliation of SAEs, laboratory data, vendor data, and other external datasets to ensure consistency and accuracy.
- Data Standards and CDISC — Explore CDASH and SDTM standards and how they support harmonisation, regulatory submissions, and global data interoperability.
- Database Lock and Study Close Out — Learn the final steps in preparing a clean, complete, and audit ready clinical trial database.
ONLINE INSTRUCTOR-LED COURSE
Organizers: Avantyo Institute of Clinical Research
Location: Online
Duration: 2-day session
Training days: April 10-11, 2025
Training time: From 10 AM GMT+2
Language: English
Trainers: Florin M. Petruțiu (USA), Cristian Ștefănescu (UK)
Attendance only by online reservation. Booking available after registering on this site.
WHY ATTEND OUR CLINICAL DATA MANAGEMENT (CDM) – ENTRY LEVEL COURSE?
Comprehensive understanding of the clinical data lifecycle. Gain a clear and structured overview of how clinical trial data is collected, validated, cleaned, and prepared for analysis. Participants learn how data flows from investigational sites into EDC systems, how discrepancies are managed, and how high‑quality datasets are produced for regulatory submission. This foundation enables learners to understand the full data journey within modern clinical research.
Expert trainers with real‑world data management experience. Learn from experienced data managers, CDISC specialists, and EDC professionals who have worked across CROs, pharmaceutical companies, and global clinical programmes. Their practical insights help bridge the gap between theoretical concepts and the realities of day‑to‑day data operations. Examples include specialists in Medidata Rave, Oracle InForm, Viedoc, and SDTM mapping.
Mastery of essential CDM skills and tools. Develop the core competencies required for entry‑level CDM roles, including CRF design, EDC navigation, query management, data cleaning, SAE reconciliation, and basic CDISC principles. Participants learn not only the “what”, but also the “how” – enabling them to perform tasks efficiently, accurately, and in line with regulatory expectations.
Strong focus on data quality, compliance, and global standards. Understand the regulatory frameworks that govern clinical data, including GCP, ICH E6(R3), ICH E8(R1), GDPR, and CDISC requirements. The course emphasises data integrity, audit trails, ALCOA+, and inspection readiness, ensuring participants can support compliant, high‑quality data delivery across all study phases.
Practical, hands‑on experience with real‑world scenarios. Participants work through practical exercises such as building CRF pages, entering mock data, running edit checks, resolving queries, and reviewing data listings. These activities provide the confidence and competence needed to perform CDM tasks from day one in a professional environment.
A strong foundation for career development in clinical research. Whether transitioning from CRC/CTA roles, entering from IT/Data backgrounds, or starting a new career in clinical research, this course provides the essential knowledge and practical skills required to secure entry‑level CDM positions. Graduates are well‑prepared for further development in Advanced CDM, CDISC SDTM, EDC systems, and RBQM.
For discounts and assistance, or if you wish to be placed on a waiting list for the next course, or require any additional information, please contact us at diana.lupu@avantyo.com (+40 0726 840 456). Be sure to mention your specific educational requirements in clinical trials.
This course is designed for individuals working in, or aspiring to enter, Clinical Data Management or related data‑focused roles within clinical research. It is equally suitable for professionals involved in trial operations who require a solid understanding of how clinical data is collected, validated, cleaned, and prepared for regulatory submission.
Clinical Data Managers play a central role in ensuring that trial data is accurate, complete, and compliant with GCP, ICH, EU‑CTR, and CDISC standards. Their responsibilities span CRF design, EDC oversight, query management, data review, and collaboration with monitors, statisticians, and wider study teams. This training strengthens both foundational knowledge and practical skills required for high‑quality data delivery.
This course is ideal for:
- Aspiring Clinical Data Managers seeking a structured entry point into the field.
- CRCs, CTAs, and junior CRAs looking to transition into data‑focused roles.
- IT and Data graduates interested in applying technical skills within life sciences.
- Life science graduates (biology, pharmacy, chemistry, biochemistry) seeking an accessible route into clinical research.
- Research Nurses and Study Nurses who want to expand into data‑oriented responsibilities.
- Site Administrators and Research Support Staff involved in documentation, data entry, or communication with sponsors/CROs.
- Professionals transitioning from healthcare, laboratory, or administrative roles who require structured training in clinical data processes.
Key Skills and Competencies Developed
- Effective communication – collaborating with monitors, investigators, and cross‑functional teams.
- Attention to detail and data accuracy – ensuring data integrity and compliance with ALCOA+ principles.
- Organisational capability – managing queries, timelines, documentation, and data review cycles.
- Regulatory and ethical awareness – understanding GCP, GDPR, ICH E6(R3), and EU‑CTR expectations.
- Problem‑solving and critical thinking – addressing discrepancies, resolving data issues, and supporting database lock.
- Technical proficiency – navigating EDC systems, CRF structures, edit checks, and basic CDISC concepts.
Recommended Qualifications and Experience
- Educational background in life sciences, IT, data science, nursing, pharmacy, or a related discipline.
- Previous experience in clinical research, healthcare, laboratory work, or data‑related roles is beneficial but not required.
- Familiarity with ICH GCP and regulatory expectations is advantageous; GCP certification is highly recommended.
Clinical Data Managers are essential to the success of modern clinical trials. By developing the knowledge and practical skills covered in this course, participants will be well‑prepared to support accurate, compliant, and efficient data handling – contributing directly to the reliability of clinical evidence and the advancement of medical science.
Florin M. Petrutiu Chief Information Officer, SiteCentric
As Chief Information Officer and Chief Information Security Officer at CNS Healthcare, Florin has led the strategic development of clinical technology infrastructure, data governance frameworks, and security programmes that support multi?site clinical operations. His work integrates operational efficiency, regulatory compliance, and modern digital capabilities, ensuring that clinical systems remain secure, resilient, and aligned with Good Clinical Practice and 21 CFR Part 11 expectations.
Florin’s expertise covers the full spectrum of clinical?technology enablement, including ERP and CTMS implementation, eRegulatory systems, SaaS product strategy, SDLC governance, Agile delivery, cybersecurity risk assessment, and incident?response planning. He is recognised for his ability to translate complex technical concepts into practical, operationally relevant guidance for clinical research teams.
He holds a Master of Information Technology and a Graduate Certificate in Healthcare Information Technology from Virginia Tech, alongside a Bachelor of Science in Information Technology with a focus on software engineering. He is a Certified Information Systems Security Professional (CISSP) and a Lean Six Sigma Black Belt, reflecting both his technical depth and his commitment to operational excellence.
Florin has been acknowledged for his contributions to healthcare technology, including receiving the 2020 HealthIT Hero award from the College of Healthcare Information Management Executives (CHiME) for his leadership during the COVID?19 pandemic. He is an active member of InfraGard, CHiME, and AEHiS, and contributes regularly to industry forums on cybersecurity, HealthIT strategy, and organisational resilience.
His professional background includes:
- Chief Information Officer and Chief Information Security Officer, CNS Healthcare
- Over 15 years’ experience in clinical research technology, cybersecurity, and operational leadership
- Extensive experience implementing CTMS, eRegulatory, ERP, and cloud?based clinical systems
- Leadership of cybersecurity strategy, risk mitigation, and incident?response programmes
- Development of data governance frameworks and security architectures for regulated environments
- Published contributions on HealthIT, cybersecurity, and national?level threat mitigation
- Lean Six Sigma Black Belt and CISSP certification
- Master of Information Technology and Graduate Certificate in Healthcare Information Technology (Virginia Tech)
In training environments, Florin is valued for his clarity, his structured approach, and his ability to connect technical, operational, and regulatory requirements into a coherent, practical framework. His teaching emphasises real?world application, system reliability, and the critical role of secure, well?designed technology in modern clinical research.
Cristian Stefanescu CEO, COML Ltd
Cristian Stefanescu is a United Kingdom?based data and systems specialist with more than thirty years of experience across engineering, academia, and information technology leadership. His career combines analytical discipline with operational depth, enabling him to explain complex technical concepts with clarity, structure, and precision.
Cristian began his professional work as a Senior Lecturer at the Technical University of Civil Engineering in Bucharest, where he taught water treatment, hydraulics, and relational database systems. His academic activity included mathematical modelling, software development for engineering applications, and contributions to peer?reviewed publications, including the Hydrogeology Journal. This early focus on structured analysis and data modelling continues to inform his contemporary approach to clinical data education.
He subsequently served as Information Systems Director for Eastern Europe at Medicover (Synevo Division), where he led multi?country technology operations across five European Union markets. His responsibilities covered system architecture, enterprise resource planning governance, information technology strategy, and the digital infrastructure supporting more than twenty diagnostic laboratories. This role provided extensive experience in regulated environments, operational processes, and cross?functional system implementation.
He later founded Ka&Te Associates, an information technology consultancy operating in Bucharest and London, where he managed software development, infrastructure administration, and technology projects for a diverse client base, including healthcare and laboratory organisations working within regulated frameworks.
In 2018, Cristian co?founded COML Ltd, a London?based information technology consultancy, providing systems analysis and operational support to organisations engaged in data?intensive and compliance?driven activities. This work complements his ongoing practice as a consultant and trainer, specialising in systems thinking, data structures, and the operational foundations of clinical research technology.
He holds two Master of Science degrees – one in Water and Wastewater Treatment and one in Groundwater Engineering – and is an NLP Master Practitioner. His teaching style is defined by clarity, logical sequencing, and the ability to connect technical, operational, and regulatory domains into a coherent learning framework.
Professional background includes:
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- Over thirty years of experience across academia, engineering, information systems, and consultancy
- Information Systems Director for Eastern Europe at Medicover (Synevo Division), managing multi?country technology operations
- Founder of Ka&Te Associates, delivering consultancy, software development, and infrastructure management
- Co?founder of COML Ltd, a London?based information technology consultancy established in 2018
- University Senior Lecturer in water treatment, hydraulics, and relational databases
- Author of scientific publications in modelling and computational engineering
- Master of Science degrees in Water and Wastewater Treatment and in Groundwater Engineering
- NLP Master Practitioner (IANLP)
Cristian is recognised for his structured, analytical approach and his ability to demystify technical subjects for learners from both scientific and non?technical backgrounds. His multidisciplinary expertise provides a robust foundation for understanding the systems, processes, and data structures that underpin modern Clinical Data Management.
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