How do you select the best Electronic Data Capture (EDC) system for your study? What are the must-have features and what are the nice-haves? We have asked Pedro M. Lledó, a Clinical Data Management professional with over 20 years experience, to share his tips for choosing the right EDC based on its functionality.
Key factors to consider
When you are looking for a new EDC system for a study, you should consider the following key factors:
- Vendor – find a reliable and seasoned company, with years of experience. They know how to avoid the most common errors when it comes to selling and implementing an EDC.
- Type of study – the EDC choice depends on the type of study and the type of users involved. You don’t always need to get the most expensive and powerful EDC on the market. For example, for Phase I or Observational studies you shouldn’t search for a complexity of an eCRF for an oncology study.
- System functionalities, including how the system is hosted (cloud or on premises).
When choosing a system, make sure you involve all the teams you’ll need during the study. Talk to them in advance and let them know what the adoption of a new EDC system means. For instance, if you involve only IT and DM departments, they can choose a system which does not support partial SDV. Clinical Operations department will learn about the system right before the study. When they discover that the partial SDV is not available, they will be concerned, as it is very important for them and for the sponsor.
The features listed below will ensure that you have efficiency, data integrity, smooth workflow, and your independence in training clinical personnel.
When you have identified several EDC candidates, check if they correspond to the most important criteria. Your future EDC should be:
- Compliant – it must be a system that follows 21 CRF part 11 rules, ensuring it is FDA and EMA compliant.
- Internet browser agnostic – it should run in the most popular browsers.
- Easy to program different types of queries, intra page, inter page/visits – it should be possible to address the queries not only to the investigator site, but also to CRAs, DMs, and MMs.
- Allowing per user access control – every user, depending on the assigned role(s), should have access only to the allowed data or actions.
- Flexible – you should be able to create on page queries and offline periodic listings and reports. This is important because you need to receive the warnings at the datapoint where the problem is located. In addition, you need some standard periodic listings to group all the queries by type, page, module etc.
- Easy to monitor – this includes the presence of integrated reporting, standard study performance reports, KPIs, metrics. We need to see how people that are related to the data cleaning are performing.
- Easy to master independently – alongside a user-friendly interface, it is important to also have on-line help resources.
The functionalities listed above are critical for having an efficient EDC that allows you to capture data in a smart way. However, if you would like to reduce the number of errors in your data, further boost data integrity, and ease the life of your Data Managers, I suggest to look for an EDC that allows you to:
- Easily configure register of data managers, CRAs, sites and user accounts.
- Carry out partial source data verification (SDV monitoring). This function allows you to save the resources and focus only on the critical variables during the verification process.
- Configure query workflow. It gives you additional flexibility and control when it comes to defining the query workflow, thus reducing such risks as overriding queries.
- Use it also on portable devices with a nice page rendering. A lot of medical personnel use mobile devices for activities control and CRF data entry.
- Optimize data management with dynamic CRF environment per protocol or patient data. In such EDC, different visits/pages or modules will appear/be hidden dynamically in a patient CRF. CRF will adjust automatically the number of pages or modules to the amount of information.
- Gather from/share data with other systems, like eTMFs, CTMS, ePRO systems, patient wearable data management systems, PhV systems, BI tools and reporting systems, etc. This reduces the amount of effort during the data input and ensures data integrity.
- Carry out training online through an e-Learning training module.
Don’t forget to ask about the technology layer behind the system. Trust a reliable and performant database, with a dynamic, quick page loading and rendering front end.
Finally, do not rush! Take your time to find the appropriate EDC. It will later save you time, money, and stress.
Would you like to learn more about choosing the right EDC and our proprietary EDC solutions? Send us your questions at firstname.lastname@example.org and we will get back to you as soon as we can.
About Pedro M. Lledó
Pedro M. Lledó is a physician by training who has been participating in clinical research projects for more than 20 years either as IT specialist, database administrator or clinical research data manager. Prior to joining Arithmos he has held leadership positions within CROs and biotechnology companies as Head of Data Management and Biometrics.