Trial management queries

Here you can find answers to some of the frequently asked questions by research staff at hospitals. This information is correct according to Protocol V5.0 18_Jun_2020.

Data management queries

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

Please email to be sent the username and password.

How do I get eRDC access?

Before we are able to grant you access, we require a completed Site Staff Registration form, and that you have been signed off on the Site Signature and Delegation Log by the Principal Investigator. If you have not done so already, please email these documents to, along with your request for eRDC access. We will then grant your access and email you the relevant login details.

How are patients randomised to treatment arms?

Randomisation will be performed according to a 1:1:1 ratio (Usual Care [Control Arm] vs. Research Arms) using a minimisation program with the stratification variable “Care status: On ward vs ICU”, where relevant to the Research Arms. Patients will be randomised into either a control group, or to receive interventional treatments that are available at their site. Upon patient randomisation a Trial Number (TNO) will be given sequentially based on the overall number of patients in the trial across all sites.

Can sites use their own structure within the Site File?

No, please use the folder structure provided within the electronic Investigator Site File (eISF). This is important for monitoring and long-term archiving purposes.

What document versions are we on?

Please see our Trial Documents page for the most up to date versions.

Clinical queries subsection

How soon after randomisation must a patient receive treatment?

Treatment should occur as soon as possible after randomisation (ideally between 24-48 hours), however the current protocol does not stipulate any cap on this time limit.

How do I enter register a patient when I have confirmed they meet the eligibility criteria?

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

Do you allow eligibility waivers?

It is the CRCTU’s policy to never allow any eligibility waivers. No exceptions will be made. The patient should meet the eligibility criteria in the latest version of the Protocol with R&D Capacity and Capability in place at your site.

How do I take consent from a patient with no capacity?

In the case of a patient that does not have the capacity to sign a consent, either the Patient or Professional Legal Information Sheets and Consent Forms can be used.

How do I order more IMP?

Please complete the CATALYST Drug Order Form and send it to the CATALYST trial mailbox.