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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.

This course would be suitable for NHS/academic research staff who have limited experience in protocol writing/review, and who want to gain a better insight into the key information required in the writing of a trial protocol.

This course will be useful to staff involved with the collection and management of trial data at a trial site. Identifying the root causes of data inaccuracies can help to promote accurate data collection and provide focus for the types of quality control checks that would be useful to implement

The aim of this workshop is to provide participants with a sound grounding in the standards required when receiving consent in clinical research. It provides an introductory overview upon which clinical competence can be developed to meet local Trust needs and requirements.

As a result of this course, participants should have the knowledge required to set up and maintain an Investigator Site File (ISF).

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 and set up and maintain an ISF