• FAQs

Please familiarise yourself with our comprehensive FAQs. If you can't find the answer you are looking for please CONTACT US.

The MonTe System

This GxP cloud-based solution enables investigator site teams to work smarter by digitising manual processes, while ensuring our Study drugs are available to patients. This new, user friendly system will resolve Temperature Excursions in seconds rather than days! MonTe is being rolled out globally across investigator sites as part of AstraZeneca’s commitment to making clinical trials more efficient, effective and patient centric.
When your study has been aligned to use MonTe, you should received a invitation email from your AstraZeneca monitor welcoming you to the new system (if your study is live and you have not received this please contact the MonTe Help Desk. You may initially use both ways of working at larger sites as the system rolls out - your AstraZeneca Monitor will advise when your studies have moved to MonTe.
If you are using MonTe for the first time please refer to the invitation from your AstraZeneca Monitor. If you’ve not received this please reference our User Guides contact the MonTe Help Desk.
If you have difficulties logging in or accessing any part of the system please reference our User Guides or contact the MonTe Help Desk.
The first time you log in to the system you will automatically be asked to change your password. On the MonTe login page there is a 'forgotten password' link. Click this and the system will walk you through the steps to change your password.
Check you have entered the password correctly, if then there is still a problem, on the MonTe login page there is a 'forgotten password' link below the password box. Click to change your password. If you require further assistance, please contact the MonTe Help Desk.
There are numerous resources within this Portal including a video about MonTe, quick start 'User Guides' and 'Video Tutorials'. If you need further assistance please contact the MonTe Help Desk.

WebLoggers

The old style Temperature Monitor contains data within the USB. The new webLogger contains data sent to the cloud. Study Drug shipments have in the past used 17 different settings on a Temperature Monitors, but the new MonTe system uses just one webLogger.
In the unlikely event of this happening please immediately contact the MonTe Help Desk.
Please see the 'Shipment webLogger Upload' User Guide for simple, clear explanations. You can also contact the MonTe Help Desk.
Please remove and reinsert the webLogger - instructions should appear on the screen. You can also refer to the User Guides If this does not help, please contact the MonTe Help Desk.
stop the webLogger manually by pressing and holding the 'stop' button for three seconds. It will automatically stop when plugged into the USB port on your device. The webLogger will give you a series of instructions to upload the data. For more details on the temperature upload result and product receipt process, please refer to the 'Shipment webLogger Upload' User Guide.
Please keep your webLogger for a minimum of 48hrs from receipt of shipment before disposing of it sustainably in line with your site protocol. You must retain the webLogger in case there is a system outage, and you are required to reload the data.
In the unlikely event of this happening, please immediately quarantine your shipment and contact the MonTe Help Desk.
Please immediately quarantine your shipment and contact the your AstraZeneca Monitor or MonTe Help Desk.
You should insert the old style Temperature Monitor into your device, download the PDF, and check the data to confirm if your Study Drugs can be used or should be quarantined. If you believe your study is now using MonTe, there may have been a packing/supply issue. In the unlikely event of this happening you should immediately contact the AstraZeneca Monitor or MonTe Help Desk.
If your shipment contains a MonTe webLogger, insert it into your local device USB port for simple, step by step instructions on how to check the temperature data. If your shipment contains an old style temperature Monitor, insert it into your USB port and read and print the PDF report. If you need further assistance, please contact the AstraZeneca Monitor or MonTe Help Desk.

Reporting a Temperature Excursion

Data should be entered through MonTe, this is now a system automated process. Please refer to the 'Report an Excursion' User Guide for an explanation.
If you have an old style Temperature Monitor, please use the standard AstraZeneca Temperature Excursion Reporting Form. If you have a MonTe webLogger, click on 'Manual Storage Upload', select your impacted 'Storage Location Logger' and input your excursion details. This process is outlined in the 'Report an Excursion' User Guides. Should you have any problems please contact the MonTe Help Desk. Please do not contact your AstraZeneca Monitor as he/she will not be able to help you
You must physically quarantine the affected kits in the IRT and then follow your local site procedures. The system will automatically notify all stakeholders within AstraZeneca.
Over 85 per cent of excursions will automatically resolve in seconds! Should further investigation be needed, the AstraZeneca Temperature Control team will email you once the excursion is resolved. All questions should be directed to the MonTe Help Desk. Please do not contact your AstraZeneca Monitor as he/she will not be able to help you.
When you upload a webLogger, you will receive a data upload conclusion stating: no excursion; excursion detected - no action; excursion detected – quarantine. If an excursion requires additional analysis, MonTe will automatically send you an email alert, which will be shared with your AstraZeneca team for action.
MonTe will automatically resolve over 85 per cent of excursions in seconds. If your temperature excursion requires evaluation this could take a number of days. If there is a delay, please contact the MonTe Help Desk. Please do not contact your AstraZeneca Monitor as he/she will not be able to help you.
The MonTe Help Desk is your first line of support.
The Training and Support page of the MonTe Portal is your first line of support. Here you will find quick start User Guides and Video Tutorials to help you access and use MonTe. For all other assistance please contact the MonTe Help Desk.
The MonTe system is being rolled out over a period of months, one AstraZeneca study at a time, so larger sites may initially use both ways of working. You will be advised by your AstraZeneca Monitor once all your studies have moved to MonTe.

Additional MonTe functions

This is the location where you store your Study Drugs which your AstraZeneca Monitor set up during onboarding. If you need any more information please refer to the 'Storage Temperature Logger Registration' User Guides, or contact the MonTe Help Desk.
Please refer to the 'Storage Temperature Logger Registration' User Guide on the 'Training and Support' page of the MonTe Portal, or contact the MonTe Help Desk.
Yes you may. Please refer to the 'Storage Temperature Logger Registration' User Guides for an easy explanation. If you require further assistance please contact the MonTe Help Desk who will help you set this up based on location naming and protocol.

Training and Support

There are numerous resources on the MonTe Portal. These include short 'User Guides' and 'Video Tutorials' If you cannot find what you need, please contact the MonTe Help Desk.
Yes, the User Guides and Video Tutorials can be downloaded as pdf files from the Training and Support page (insert link) on the MonTe Portal.

Other

Yes you may for clinical or administrative purposes. Please contact your AstraZeneca monitor to add a colleague to the system.
Yes as part of AstraZeneca’s commitment to sustainability we ask you to recycle and dispose of the webLoggers in line with your local site protocols. Please ensure you retain the webLogger for 48 hrs after receipt to ensure the data has been fully uploaded into MonTe.
Yes. Please refer to the sustainability protocols at your site.