How to submit an asset for assessment and prioritisation for inclusion in Glo-BNHL?

Information regarding a potential asset for consideration for inclusion in the trial should be submitted electronically to the trial mailbox: Glo-BNHL@trials.bham.ac.uk.

This documentation should include a completed summary sheet (downloadable below) and additional detailed information (in any suitable format) covering the following information:

Members of the TSC will review the information pack. A decision regarding inclusion in the trial will be reached during offline review of the documentation and a TSC videoconference. Every reasonable effort will be made for all TSC members to be present however the minimum attendees required for the TSC to be quorate for decision-making has been defined in the approved CRCTU Charter as “at least seven members, including a statistician, one trial management group member and three clinicians (including the Chair, unless otherwise agreed)”. Additionally a videoconference will be offered between the relevant industry partner and the Sponsor/Chief Investigator to allow for questions and clarifications prior to a final decision being reached.

The TSC have committed to returning the final decision regarding inclusion of the asset in the Glo-BNHL trial within four weeks of receipt of the information pack. The decision will be returned in writing alongside a detailed summary of the rationale to facilitate subsequent interaction with the relevant regulatory bodies.

Industry Information Pack:

• Asset Submission Guidance [PDF 698]
• Asset Submission Form [PDF 142KB]