Trial Operational FAQs

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

Patients should be registered to the trial in the electronic Remote Data Capture (eRDC) system, Medidata Rave. Contact the Trials Office to request access to Medidata.

• How do I access the electronic Remote Data Capture (eRDC) system? 

All data entry for the Glo-BNHL trial is done through the electronic Remote Data Capture (eRDC) system, Medidata Rave. To request access to Medidata, email the Trial Office. Please note, you must have completed the Site Staff Registration Form/Investigator Registration Form as appropriate, and have a complete entry on the Site Signature & Delegation Log before access can be granted.

• Who do I contact if I am experiencing problems with the eRDC system?

If you experience any problems with the eRDC, contact the Trial Office. If out or hours, contact the Medidata HelpDesk  (available 24 hours a day, 7 days a week).

• What is the adverse event (AE) reporting period?

Details of all AEs (see protocol for exceptions) will be documented and reported from the date of signing the informed consent form until 90 days after the administration of the last treatment. Refer to protocol section 13 for further information.

• How can I report an AE?

All AEs (including SAEs) should be reported in the electronic Remote Data Capture System (eRDC), Medidata Rave. Contact the Trial Office to request access to Medidata.

• When does the trial close to recruitment?

The trial is currently planned to recruit for 7 years from the date of trial opening. The current planned end of recruitment date is 01-May-2031. 

• How do I check what treatment arms are currently open for recruitment?

Contact the Trial Office to check what treatment arms are currently open for recruitment.

Refer to the Glo-BNHL protocol and relevant treatment arm sections for clinical queries or contact the Trial Office. 

• How do I place an IMP order?

IMP supply and ordering is managed electronically by Medidata Rave Randomiation and Trial Supply Management (RTSM). Initial stock will be sent to sites at site activation, and subsequent orders will be automatically triggered based on inventory levels and enrolment, however manual shipments can be arranged where necessary. Conatct the Trial Office if you have any questions or require access to Medidate Rave RTSM. 

• 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.