Trial Management Queries (FAQs)

Here are some answers to some of the most commonly asked questions by research staff at hospitals.

Registration

  • How do I register the patient to the trial when I have confirmed they meet the eligibility criteria? 

Please follow the instructions found in Section 6 of the Protocol.

Data management

  • How do I access to the eRDC (electronic remote data capture) system? 

Please email Glo-BNHL@trials.bham.ac.uk to request access to the eRDC system (Medidata RAVE). If you have not done so already, we will request that a Site Staff Registration Form is completed, and that you have a complete entry on the Site Signature and Delegation, before we are able to grant you access to the eRDC.

Clinical queries

  • Is the patient allowed palliative radiotherapy whilst on treatment? 

Please refer to the treatment arm-specific ‘Supportive treatment’ section of the Protocol. Guidance will only be included here if we have received it for that particular drug. If it is not included, please email Glo-BNHL@trials.bham.ac.uk for further guidance.

  • Do you allow eligibility waivers? 

It is the CRCTU’s policy not to allow eligibility waivers. There will be no exceptions. The patient should meet both the Core and Arm-specific eligibility criteria in the latest version of the Protocol with R&D Approval in place at your site.

  • Is there a maximum treatment interruption length allowed?

Please refer to the Arm-specific ‘Dose Modifications’ section of the Protocol.

Investigator Site File

  • Will you supply additional folders for the Investigator Site File? 

Yes. If you are running out of space, please email Glo-BNHL@trials.bham.ac.uk for resupplies.

  • How do I get the login details to download documentation from the website? 

Please email Glo-BNHL@trials.bham.ac.uk for your username and password. 

Other

  • When does the trial close to recruitment?

The trial currently plans to recruit for 7 years from date of trial opening. 

Publicity

  • Can I tweet about Glo-BNHL? 

Of course! Please use the hashtag #GloBNHL for any relevant tweets about your experience of the trial. If you have your own departmental account or hashtag that we can acknowledge in our tweets please let us know.

  • Are there any Glo-BNHL slides I can use?

Please email Glo-BNHL@trials.bham.ac.uk for an up to date slidedeck.