EDC2Go will be discontinued by the end of 2019 and existing clients are encouraged to migrate to a more costly EDC solution, namely Staicy. Other EDC vendors have begun to provide migrations options, but with the cost of "migration fees". From this blog post, you will learn how you can migrate eCRF data from your ongoing study in EDC2Go to SMART-TRIAL for free (no migration fee).
If you are using EDC2Go for electronic datacapture, and your clinical study is collecting data for the next 12 months or more,you should start planning your migration to an alternative EDC solution.
The longer you stay and the more data you collect in EDC2Go, the more data you will need to migrate. With more data to migrate, the more likely you are to experience downtime in data collection during the migration phase. Downtime in data collection can be critical for your study, especially if your protocol is time sensitive. If not mitigated correctly, you will risk;
Altogether, this will increase the strain on your clinical teams and site staff, increase overall expenses and cost, and negatively impact study results.
But, there’s good news: migrating fromEDC2Go to SMART-TRIAL doesn’t have to be complex, time consuming, or costly.With SMART-TRIAL it can be done with minimal or close to no downtime – and withoutany additional cost, such as “migration fees”.
After reading this blog post, you should bebetter informed of the work that’s required from your team, and approximately howmuch time it will take for your study.
Let’s look into how you can migrate your eCRF data from EDC2Go to SMART-TRIAL and what is required to ensure a successful transition for everyone involved.
Migrating eCRF data from one EDC system to another can be quite complex and costly. This is mainly due to the fact that no system is alike, in terms of architecture or data format.
Because of this, many vendors charge high "migrating fees" for migrating data from other EDC systems to their own, because the work involved in migrating the data from one architecture requires software engineers or data managers with the appropriate technical know-how. Other vendors don't even provide prospects with the possibility to migrate any data.
However, SMART-TRIAL has taken a different approach on the matter and opened up for the possibility to import data from any other EDC system. The only requirement is that the eCRF design be the same in both systems.
The migration of data does not require any technical knowledge as such, and can be done by you and your team by simply following the SMART-TRIAL import file structure.
The first phase in migrating eCRF data from EDC2Go to SMART-TRIAL is the preparation phase.
Because migration of eCRF data from EDC2Go to SMART-TRIAL not only involves setup of the eCRF itself but also training of site staff and import of data, everything has to be carefully planned out in order to minimize any downtime.
SMART-TRIAL provides all users with a simple“do it yourself” user interface, to setup eCRFs. As such, you can easily mirrorthe EDC2Go setup of all eCRFs in SMART-TRIAL by yourself.
During the preparation phase, you shouldcomplete the following tasks:
Remember: It’s important that any amendments on the eCRF setup in SMART-TRIAL, from what you have in EDC2Go, is clearly noted. If not, this will increase the complexity of your migration as you will have to adjust the data format to the new standard. We recommend that small changes to your study setup be done after the migration of data.
This phase, can take everywhere from 1 to 6 weeks, depending on your study complexity. In other words, you can multiply the number of visits with 2 days.
After setup of eCRFs is completed in SMART-TRIAL, migration and import of the eCRF data has to be completed. If you have multiple sites, we recommend that you plan this accordingly with each site, or with all sites together – depending on the status of recruitment and ongoing subject visits.
As such, the site must be asked to stopusing EDC2Go while migration and import of data is ongoing.
In this phase you will have to export alldata from EDC2Go and transform the data into a special SMART-TRIAL formattedimport document. This document is delivered to you by the SMART-TRIAL team aftersetup is completed.
While transforming the data, no new datacan be entered into EDC2Go.
Depending on the no. of forms, studycomplexity, and quality of the EDC2Go setup, this can take anywhere from a few hoursto a couple of days.
During this phase, you will have to map thecorrect answers to the SMART-TRIAL format. After data has been transferred to aSMART-TRIAL format, the eCRF data can be imported.
SMART-TRIAL experts will enroll all subjects to the appropriate sites in SMART-TRIAL, and data can be imported using the SMART-TRIAL import module. The data import itself doesn’t take longer than a couple of minutes – hours at most if any mismatches are found that have to be corrected.
The last step, but certainly not the least, is the validation of the data import and resumption of data collection, from within SMART-TRIAL. This ensures that migration and import of data was done correctly – to ensure high quality of data.
Because SMART-TRIAL’s import module imports all data in the same way for eachanswer for all subjects, any plausible errors that can originate during migrationand import are systematic. It’s therefore enough to do a review of data for onlya handful of subjects within SMART-TRIAL.
This validation review should only be done after all data has been imported for each site.
By manually reviewing the whole pathway foreach subject, and comparing data with the EDC2Go export, you can validate ifthe data has been transferred correctly. Any mismatches that are found for onesubject in SMART-TRIAL, are most likely systematic and can be corrected by fixingthe import file and redo the import.
After validation is completed, you can recommendyour site(s) to re-initiate data collection in SMART-TRIAL, where all subjectsand their data will be available.
Validation of data does not have to take more than 1 day at maximum – depending on the no. of visits and the amount of data in each visit.
With these three phases in mind, you can start planning your migration from EDC2Go to SMART-TRIAL. By now, you should have an idea of how much time and work is required from you and your team, and what kind of tasks have to be conducted.
Furthermore, migrating your eCRF data doesn’t have to be complex or cost you any serious time. However, it’s important that it’s well planned and executed correctly, both in cooperation with the sites and the SMART-TRIAL customer success team.
Lastly, the migration of data format to the SMART-TRIAL import format is by far the most time-consuming task, but if planned well, it should be easy to accomplish.
Want to get started with SMART-TRIAL? Contact us by clicking the button below, and we’ll send you the license & pricing details for SMART-TRIAL eCRF and help you plan your study migration from EDC2Go.