Objective :This training is intended for personnel working within the pharmaceutical and health
environment who will participate in the preparation of protocols for clinical trials or
epidemiological studies.
Program :
The following description is provided for information. The training will include but is not limited to
the topics presented below. Its content may be modified upon BIOWIN representative’s request
in order to answer specific expectations and needs. Depending on the extent and nature of the
changes, costs may be revised in order to take into account the additional time needed for the
preparation of training documentation.
Introduction
- Performing clinical trials in the EU and US
- The importance of the study protocol
- Overview of ICH guidelines related to study design and conduct
- The role of the clinical team
The Protocol Ouline
- Types of study and study design
- Inclusion/exclusion criteria
- Study objectives and test hypotheses
- Safety measures and endpoints
- Efficacy measures and endpoints
From Protocol Outline to Full Protocol
- Transforming the Outline into a Protocol
- Detailed information on study conduct –what should go into the protocol
Other study-related documents
- Informed Consent
- Investigator Brochure
- Case Report Form
- Product Information
Amending the protocol
Method : Practical development of a protocol, using a published trial as an example.
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