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Target Audience: All researchers and associated staff who will be responsible for the running of a trial and for R&D Managers/Facilitators with monitoring/audit responsibilities

Aims and Objectives: :  As a result of this course, participants should be provided with the knowledge required to set up and maintain an Investigator Site File (ISF) and by the end of the session attendees will be able to:

- Understand the purpose of an ISF

- Identify the essential documents required in an ISF

- Understand the importance of maintaining an ISF

- Set up and maintain an ISF

Course Summary:     Using a mixture of presentations and activities, delegates will learn about:

- The purpose of a Site File

- What the Essential Documents are

 - Maintenance of the Site File

  - How to set up a Site File

A protocol is the document that specifies the research plan for the clinical trial. It is the single-most important quality control tool for all aspects of a clinical trial. This course will provide attendees with the opportunity to review a protocol template, well designed in compliance with the SPIRIT guidelines. It will in addition provide explanation of the requirements to be included in the individual sections and the reasons for their inclusion.

A protocol is the document that specifies the research plan for the clinical trial. It is the single-most important quality control tool for all aspects of a clinical trial. This course will provide attendees with the opportunity to review a protocol template, well designed in compliance with the SPIRIT guidelines. It will in addition provide explanation of the requirements to be included in the individual sections and the reasons for their inclusion.