27 May 2019
Here comes the latest update about the randomization settings in MainEDC™ directly from DM 365 R&D team.
From now on you can set up essential types of randomization right in the interface of the system on your own.
How does it work?
You just upload the randomization list in Excel or CSV format to the system. Don’t bother about the layout of the list – the system will handle any of it.
MainEDC™ will run general validation rules on the randomization parameters grouping – if it detects any record duplicates or overlapping criteria, the system will highlight them.
With the randomization list on board, MainEDC™ will automatically complete the required references – treatment groups, stratification parameters, blocks.
For your convenience, the system provides a wide range of flexible settings - such as randomization number, randomization stamp, notifications, etc.
In the case of stratified randomization, IWRS will be configured in the following way:
a) eCRF or site information can serve as the source of stratification parameters – for example, pharmacokinetic assays taken by the site.
b) The number of strata can be as large as required for the study, there are no restrictions here.
c) The system will automatically check the accuracy of stratification settings.
You upload the kit list of any structure in Excel or CSV format. The system will check the consistency of the list and its compliance with the randomization list.
As to the drug assignment setting, the system supports different clinical trial designs – simple drug supply, cross-over design, with pre- and post- medication, etc. You can set the drug assignment stamp and notifications just in the way you require for your study.
Should you need to unblind any of the study participants according to the protocol, or replace a kit and set the relevant notifications, you can easily do that, thanks to all the convenient tools that are at your disposal in the system. The same is true for the automatic drug supply procedures configuration at the site or study level.
What’s more, the system provides an Event Viewer – a mechanism that trails all the actions related to IWRS in the system and provides this data in a comprehensive human-readable format to the user.
Set your IWRS easily and quickly with MainEDC™!