Essential Documents

Canvas module (link to module will be provided upon registration)
Monday 20 March (10:00) - Sunday 31 December 2023 (11:30)

For further information please contact CRCT

Aims and objectives:

Essential documents individually and collectively permit evaluation of the conduct of clinical research and the quality of the data produced.

This course explores the process for the development, review, implementation and filing of essential documents involved in clinical research conducted at the University of Birmingham (UoB).

Target audience:

You will be a researcher involved in clinical research being run at UoB, and you would like to gain a better understanding of the process for developing, reviewing, implementing and filing essential documents in clinical research.

Why this course:

This course will cover the requirements for the development of the protocol, participant information sheet (PIS), informed consent form (ICF), case report form (CRF) and investigator brochure (IB). It will also outline examples of other documents that are essential for reconstruction of the project conduct.

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