21 March 2019 Articles

SDTM Data Export: How To Stop Worrying and Start Using It With Pleasure

Data export to SDTM (Study Data Tabulation Model) standard ensures consistent data representation and cross-study data analysis as normally required by regulatory reviewers (e.g. FDA).
Our potential clients quite often come to us with the issues and inconveniences they face when trying to export the data into SDTM format from the EDC systems they use. Their platforms host project-specific eCRFs, however it becomes not an easy task to export the data in the desired way since not all the systems allow the direct SDTM data export.
To get this job done they usually have to turn to the third parties and, therefore, spend time on finding the right contractor, dealing with additional paperwork – negotiating and signing at least one more contract – and, as a result, one more vendor management.

xx.pngYour current EDC platform hosts your project-specific eCRF but does not allow data export to SDTM standard?
xx.pngYou have to contract third parties to get this job done?
xx.pngThe service is charged per export run?
xx.pngDomains are ready by the end of study or even later?

 What’s more – they are bound and limited to the number of export runs that may be required for the study and the frequency of the data export requests.

ICH E6 R2 and ALCOAC principles mandate Sponsors to have full contemporaneous control over their study data. So, does it look like you need SDTM data export not only for data review meetings or DSMB sessions preparation? Indeed, there might be a necessity to check all the AE and SAE reported in eCRF and their medical codes or all clinically significant abnormalities in lab tests. Or maybe you would like to check all visits of a particular patient in one file and make sure all the screened subjects meet the criteria according to the protocol. Since the domain export is human readable you can perceive all this information without the technical eCRF knowledge.

There are many reasons why you may want your data exported as domains at any time in the course of the study. And here you also need to consider that the 3rd party service is usually charged per export run. Under these circumstances, it becomes quite hard to plan the project budget beforehand – you might always need one more export run all of a sudden, and for that, you always have to be ready to negotiate some more budget for these unexpected runs, which is quite inconvenient.

In MainEDC™ the approach to SDTM data export is completely different aiming to help you get full control of your study in an effortless and comfortable way. You just run your trial smoothly and don’t bother about all those headaches mentioned above.

First, you can feel at ease with continuous support in eCRF setup and domain export from the same system offered by Data Management 365 – the pre-setting for SDTM data export is made right in the process of eCRF build.

vv.pngDM 365 offers you continuous support in eCRF setup and domain data export from the same system
vv.pngCDISC standards and FDA validation rules compliance is ensured
vv.pngYou pay for tailored configuration just once and it is available on production right after your acceptance testing
vv.pngEnjoy using live datasets available on production in the real-time mode
vv.pngYou are in line with ICH E6 R2 by having full contemporaneous control over your study data
vv.pngYou download refreshed datasets as many times as you need them and not only for your data review meetings or DSMB sessions preparation
vv.pngMainEDC™ generates the datasets as a background operation, without interrupting your current session or any other user's work
vv.pngOnce your requested export is ready, the system will notify you by email and directly from the browser if you are still there
vv.pngAll downloads history is visible, every historic export is available so you can easily reconstruct the project state for that date and time

 Forget about unexpected budget negotiations – you pay for tailored SDTM data export configuration just once without additional contracts or addendum and enjoy data export in SDTM format on production right after your user acceptance testing (UAT).

What does that mean for you?

After UAT you can use live datasets in the real-time mode. Whenever you need to export your data from the system in SDTM format you can easily do that – 24 hours, 7 days per week datasets are ready for data export. Download refreshed datasets as many times as you need to keep track of your clinical study and get full control of it. For additional control you can check all downloads history – every historic export is always available so you can easily reconstruct the project state for the particular time and date.

The remarkable thing about the data export in MainEDC™ is that the export of huge data amount does not overload the system - since MainEDC™ generates datasets as a background operation, nothing will interrupt your current session in the system or other users’ work. As soon as the data is ready, you will receive a browser notification if you are still in the system and an email alert to the dataset readiness.

So, MainEDC™ substantially facilitates the process of data export in SDTM format – get the data exported just from the same system interface, export data whenever you needed - datasets are available 24 hours 7 days per week – feel free to export the data as many times as you need in the course of the study. On the whole, MainEDC™ helps to make data export in SDTM format a comfortable and resource-saving process.