https://medregs.blog.gov.uk/2018/10/22/faster-approvals-for-clinical-trial-applications-what-our-robots-have-taught-us-so-far/

Faster approvals for clinical trial applications - what our robots have taught us so far

Here at the MHRA's Information Processing Unit we are getting to know our newest colleagues –five robots called Alpha, Bravo, Charlie, Delta and Echo. While our robots don’t need tea breaks or have a social life outside of work, we are getting to know some of their habits a bit better. In particular, we're discovering they are quite particular about how they like to receive information.

The introduction of Robotic Process Automation into our operations means instant case creation of your clinical trial application onto our database, faster validation times and ultimately faster approval times but poor quality submissions will end up being handled manually which inevitably slows down the process.

Below are three things I’ve discovered that we think might help to achieve the fastest time possible for application processing.

1. Clearly name applications and files

Try putting the phrase “application form” in the title of your form as set out in the table below – this shows the ideal naming format for common documents:

In addition, making sure your application forms are Optical Character Recognition (OCR) readable and clearly naming your zip files according to the submission type for example Clinical Trial Initial, Clinical Trial Substantial Amendment and so forth, will definitely speed things up.

2. Select the correct CESP category 

Our robots are intelligent and it’s not only Clinical Trials they can handle but all submission types we receive.

To help our robots categorise your submissions and reduce the amount of manual handling needed, we have developed a simple table to show the ideal file names and the corresponding Regulatory Activity and Sub Activity to use when submitting via CESP.

3. Provide full name of sponsor 

Our robots take data quality very seriously and they want to ensure quality is upheld in our case management system.

So, completing the full name of your sponsor when filling in the initial application form (Annex 1) will make a big difference to getting the application through the automation process. You should state the company name as it is registered with the MHRA (as appears on your Acknowledgement letters).

If you use the three tips above next time you are completing a submission it will increase our chances of providing you with the fastest and most efficient service possible.

Delivering Electronic Communications 

We have recently moved away from paper communications for all Clinical Trial submission types. We will always use the e-mail address supplied in section C1 “Contact during procedure” of the Annex 1 form.

You should expect all communications to be delivered from MHRA_CT_Ecomms@mhra.gov.uk but please note we only use this to send emails out and all queries should still go to:

As we continue to improve our services we would like to hear from you to ensure that these processes work effectively and efficiently. Comment below to let us know and sign up to updates for this blog as there will be more to follow on how best to submit to us.