According to a survey done by Tufts Center for the Study of Drug Development among 194 corporations involved in clinical trials, changes mid-study are the largest headache for these organizations. Every single change takes an average of 30 days to be performed and there is usually an average of 4 planned and 4 unplanned changes in a study.
In this article we’ll tell you how to make these dreaded and complicated mid-study changes to the EDC become a simple task and avoid delays in the study because of them.
The dreaded mid-study changes in clinical trials are any change that needs to be performed in a study once it has already begun, and in most cases these changes also affect the EDC:
- Adding new variables to the study
- Adding new events or visits
- Change edit checks
- Delete variables only for specific new sites
- And endless other possibilities…
All of these changes force the EDC to be changed as well and this change brings the risk of negatively affecting the existing database of the trial.
So let’s break down the main steps to carry out a mid-study change successfully and we will tell you the keys that allow this complicated process to be done in a simple manner with ShareCRF.
Phase 1 - Configure/Plan the changes
The feared new change appears and the EDC needs to be adapted to include the changes: new fields, auto calculated fields, automatic queries, new visits or forms or anything else that needs to be changed.
These new behaviors may be applied only to a group of participants, like for instance new participants, or participants from specific sites and that must also be managed in the EDC.
The first thing will be to perform the modifications in the EDC so that it adapts to the new changes, and depending on the EDC this can be done in two ways:
- Coding the change: Someone (one or several people) with coding knowledge on EDCs will code the change into the EDC
- Configuring the EDC: no need to code and everything can be adjusted with configuration options
The second option is much faster and more accessible as it does not require coding skills.
That is the reason why in ShareCRF we have a visual editor for the configuration of the study, so no coding is required and the change can be configured in a fast and easy way.
Besides, our editor has a “secret weapon” that allows you to make the changes in a secure way.
When coding or configuring a change in a study that has already begun, it is normal that inconsistencies or errors appear in some parts of the EDC, that is why it is important to always validate all the fields.
Solving all these issues and inconsistencies takes a lot of time and is a complex task. That is why our editor has an automatic validation system that warns you of inconsistencies in the configuration and prevents these types of errors from appearing.
Once we have completed the changes, we must check they are what we expected, meaning that if we added a new field we must check that it shows in the CRF and that it works as we expected.
The wiser option would be to do that checking in a different place from the one used by the users of the EDC (remember that the study has already begun). Making the changes directly in the EDC you are currently working is the worst option:
- If a mistake is made in the change the real system used in the clinical trial will be affected and this may have serious implications for the database.
- There is no way to validate the changes before they are released into production, so any deviation found in the validation will occur in the EDC in production.
Not having an independent environment, separated from Production that will allow you to configure the change is not the best idea, any mistake will have a very high toll. Besides, in many EDCs that don’t have this independent environment you are forced to pause data collection while the change is being performed, which slows down the data collection process.
That is why in ShareCRF every study has an independent Test Environment where you can modify the current configuration of the study and test any changes without risks.
Phase 2 - Release the change in Production
Once the changes in the EDC have been completed, the next step is to release such changes in the real environment where the participant’s data is being collected.
If we assume to have a test environment, a very advisable practice, before the changes are released in production, is to make a copy of the database from Production onto the test environment, so that we can test the changes made in an environment that is most similar to the final environment.
In ShareCRF we have the possibility to copy the production database in a test environment with just the click of a button.
Once we have the production database, it would be very useful to simulate how the changes would affect the patients data. If for instance, we add an automatic query or a new automatic field, it would be great if we could run the new configuration (along with the older ones) on the existing data. This way we can know the effects that the new changes will cause on the existing data.
That is why ShareCRF has a configuration data integrity tool that allows us to run all configurations of a version of the EDC on all patients.
What is accomplished with this?
We ensure that the new configuration is being applied to all existing data and not just on the new data that will be introduced in the EDC from now on.
This is especially useful when (1) we discover an error in an auto calculated field because the error will be corrected in all existing data or (2) when we want to add an automatic query, because the query will be created not only in new data but also in all existing data the meets the conditions for the query to be created.
As a result of the use of this data integrity tool, we can consult a changes report. This report shows all the new changes occurred in the data and queries after the new change has been executed.
With this report we can verify if the changes in the current data in the study are correct.
Lastly, we only have to release the changes in the production environment, which is the environment where the real data is collected. And while in many other systems this is a manual task that usually requires the users to stop using the system, in ShareCRF this is all done just by clicking a button.
When we click on the button to publish the changes, the system will run all the necessary processes to publish the new version in the production environment with the new changes included and execute all the required changes in the existing data (if we indicate so) via the data integrity tool.
Conclusions
As you have seen, making a mid-study change in a secure and fast way is a complicated process if you don’t have the right tool box that will help you do it.
ShareCRF is designed to make performing these changes simple and easy and allows you to make changes whenever necessary which allows you to continuously improve the EDC without having to suffer for it.
In our systems, thousands of mid-study changes have been done using the tools we mentioned above. If you want to see for yourself how these changes can be done, just request a demo.
