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Withdrawal of Commercial Organisation Information Document

Date: 4th November 2020



The commercial Organisation Information Document was initially introduced across the UK with the implementation of the UK Local Information Pack in June 2019. Following feedback from stakeholders, it has been agreed across the four nations that the commercial Organisation Information Document will not be used as part of study set up from Thursday 12 November 2020.

Commercial studies use a commercial contract as the principal agreement between the sponsor and site, and feedback has indicated the commercial Organisation Information Document provides no additional information to support sites in study review and set up. To reduce unnecessary bureaucracy the commercial Organisation Information Document will be removed from the requirements.

For new submissions the commercial Organisation Information Document will no longer be required as part of the application process through IRAS from Thursday 12 November 2020.

For studies in site set up, if the commercial Organisation Information Document has been provided as part of the Local Information Pack, this can be processed and filed in accordance with local Standard Operating Procedures.

Note: The non-commercial Organisation Information Document remains a required document for non-commercially sponsored studies.

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