As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. We have put together a tracker which holds all of the IMPs, each month we search the MHRA website to see if the SPC for each IMP has been updated. As the MHRA website does not include a summary of changes or any sort of version number for the SPC, we are using the "Date of Revision of Text" found in Section 10 as our version number. We log the date of revision of text in our tracker as the version of the SPC this way we can quickly see if there have been any changes.

Without this the only way we have of reviewing for any changes is to compare the most recent SPC from the MHRA website with the SPC we hold. The eMC website does include a summary of changes, but we have seen many inconsistencies between what is available to the eMC and MHRA websites.

Our process is to check the date of revision of text, if it is different we will review for any changes and check the eMC summary. I have recently been informed that using the date of revision of text as some sort of versioning is not a reliable method. Does anyone have a different process or have any suggestions about the most effective way to maintain oversight of the SPC changes?

Thank you for your time!