IV Edition - Good Clinical Practices, Clinical Quality Assurance, and Clinical Trial Operations | Master Program in Vaccinology And pharmaceutical Clinical Development

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

Contents

Elements of the Clinical Quality System:

Quality Policies and Quality Manual, standard Operating Procedures (SOPs)
Qualification and training of staff
Qualification of third parties (Contract Research Organizations CROs)
Trial Master File
Auditing: internal and external auditing, system audits
Regulatory inspections: Preparation of an inspection (sponsor and site)
Types, procedure, reports, Frequent findings.

Introduction to Clinical Trial Operations (CTO):

From protocol to clinical study report
Clinical project management & planning.

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

Labeling & packaging of vaccines

Site qualification

Clinical research organizations (CRO)

Documentation.

Clinical trial execution:

Initiation visit, monitoring, safety, study closure - Database lock and closeout data management activities

Operational systems and processes:

Trial management systems
Efficiencies and quality control in process
Clinical Study Report.

See the lessons' list

Go back to the modules page

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

© University of Siena - Master in Vaccinology and Pharmaceutical Clinical Development - 2018 - all rights reserved