Customer Case Study Clinical Operations Academic & Healthcare RIMS
No more double work for METC Erasmus MC Previously, one person had to bring a USB stick with research documents, now they can be submitted digitally by multiple users (depending…
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Posted:4 November 2024
Previously, one person had to bring a USB stick with research documents, now they can be submitted digitally by multiple users (depending on their access rights). METC Erasmus MC arranged it, with our Regulatory Information Management System.
Erasmus MC’s Medical Ethical Review Committee (METC) plays an important role in the safety, integrity and quality of clinical studies to be conducted. This legally recognized committee has some 52 members and consists of two chambers, each of which meets twice a month and reviews medical scientific research involving human subjects.
Andrea de Jong, secretary at METC Erasmus MC, and her colleagues always make sure that all research proposals are neatly ready for the meetings. Before she used ResearchManager for this, the department had a semi-digital system. Andrea explains: “The researcher gave us a USB stick with relevant documents. We had to check these, enter them manually and prepare them on a shared local disk so the committee could meet on it. So a lot of double work. It was also a one-sided system. Submitters had no access to this system. For status updates, they had to call or email.”
Although the old system worked, it was clearly outdated and also not entirely secure. “We were ready for something more modern, some kind of portal. Because in this day and age, submitters want to manage and control their data themselves. Then we started asking around and visiting other hospitals. METC Isala Klinieken was already working with ResearchManager and we liked it. Our project manager then set everything in motion,” says Andrea.
Around 2017, METC Erasmus MC started a digitization project and began implementing ResearchManager’s RIMS (Regulatory Information Management System, formerly METC Management) module. RIMS supports regulatory authorities such as METCs with central document storage, more efficient approval processes and reporting capabilities. This saves them a lot of time and ensures a secure process.
The implementation of ResearchManager was iterative, with a lot of fine-tuning in between. Andrea: “During use, we sometimes discovered missing parts for our own process. Extra tabs, input fields for certain data, statuses that we previously kept on paper or in an Excel file. We could easily switch with ResearchManager about that and they really listened carefully to what we needed. And I’m still in touch with them every week. The system is continuously tuned to our needs and changing legislation. That cooperation and flexibility are very nice.”
The ResearchManager team also helped with the integration of the old system. All files from that system were migrated to the new METC management system. There is also a link between Erasmus MC’s project management system (PaNaMa) and ResearchManager, so that the researcher can transmit the documents to be reviewed by the METC at the push of a button. Andrea: “This prevents double work for the researcher, because they only need to enter a file into one system.”
The submission and review of dossiers, amendments and other documents is now fully digital via ResearchManager RIMS. This has also improved the security and protection of confidential dossier data. Andrea’s work has changed slightly: “I used to put the data in, now I check what the researchers themselves put in. ResearchManager is now indispensable to me. My colleagues are also enthusiastic, because you also have an overview of what needs to be done. Everything is in one place and easy to find. That digital system also helped us through the corona period at the time.”
“Researchers can track the course of a study’s assessment much better now, so I don’t have them on the phone as often as I used to,” Andrea says. “On the other hand, I do get more questions now about how the system works, especially from new users. ResearchManager itself is not complicated, but because of the high turnover among researchers, I help these new users more often. Although this can sometimes be more time-consuming, I really enjoy the contact with them.”
All done with duplication, delays and lack of overview? Discover with our free demo that managing and reviewing research proposals can also be fun.
