Good Clinical Practices, Clinical Quality Assurance, and Clinical Trial Operations

Understanding what is required and how to ensure quality in clinical trial execution, along with knowledge of the operational requirements for planning and executing vaccines clinical trials.

Module's directors

Elisa Marchetti, BSc, PhD

Head Clinical Operations
GSK Vaccine Institute for Global Health, Siena, Italy

Prof. Stefano Gonnelli

Prof. of Internal Medicine
University of Siena Siena Italy


Elements of the Clinical Quality System:

Introduction to Clinical Trial Operations (CTO):

Clinical trials preparation: Protocol, Informed Consent Form and related documents

Labeling & packaging of vaccines

Site qualification

Clinical research organizations (CRO)


Clinical trial execution:

Operational systems and processes:

See the lessons' list

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Lessons' List

Introduction to Module VIII
Protocol to submissions in a global business: from study protocol to clinical study report
Regulatory and ethical approval for a clinical study
Ethical considerations in the conduct of vaccine clinical trials
Data integrity and system validation
Identification, qualification and selection of third parties/contractors
Standard Operating Procedures (SOPs) – the sponsor perspective
Standard Operating Procedures (SOPs) – the clinical site perspective
Exercise on SOP writing
Quality, inspection, compliance & non compliance
Site qualification and management
Site Initiation
During trial monitoring
Monitoring reports, escalation of issues
Qualification and training of clinical trial staff
Monitoring with paper Case Report Form (CRF) vs. e CRF
Sorce document verification
IMP management at study site, including maintenance of bliding
Site close-out
Setup and management of a sera bank
Study conduct – medical point of view
Auditing in clinical development
Epidemiology study vs. clinical trials: differences in study design and operations
Trial management systems
Clinical Trial Documentation: essential documents, trial master file, document management, archiving
Clinical Operations in South East Asia and Latin America: the Dengue vaccine efficacy studies experience
Setup of a quality system
Serum samples: from clinical site to study results
The Good Clinical Laboratory Practice (GCLP) rules: principles & definition
Clinical Study Report
WHO and ICH GCP: tools and challenges to implementation in resource-constrained settings
Clinical Operations in a Sub-Saharan African developing country
Clinical trial management & planning
Developing a Clinical Study Protocol
Informed Consent: why and required information
Writing of study related documents
On study data management process, with and without Electronic Data Capture (EDC)
Special data handling: integration of external data
CDM: Verbatim coding and SAE reconciliation
Quality database locks and close-out data management activities

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