For the majority of us Microsoft Excel is a free and familiar tool. We use spreadsheets for a wide range of projects, but they are far from ideal when it comes to data capture in clinical trials. After all, Excel wasn’t created to build case report forms (CRFs) or to verify patient data that’s collected in clinical research. Despite the technological advances in software solutions, many organizations still cling to spreadsheets. Here are five problems with using spreadsheets to collect and store data in clinical trials.
1. Lack of compliance.
If you’re planning on submitting your clinical trial data to the FDA, there are many regulatory requirements to meet such as 21 CFR Part 11. One necessary element is traceability of any and all changes that are made to data. In an electronic data capture (EDC) system this is possible with audit trail functionality. If someone changes a value in a spreadsheet, the history of who made the change, the date and time the change was made, the old and new values entered, and the reason why the change was made are not available. You simply cannot trust something that you cannot track. Instead of relying on your interpretation of what it means to use compliant tools, it’s best to leave it up to the vendors who have had their software verified as a validatable system, by a third-party audit.
(Related article: Do SOPs for Data Collection Equal Compliance with 21 CFR Part 11?)
2. Data is not secure.
Spreadsheets have very limited permission controls when it comes to restricting access for multiple users. This lack of protection can lead to data manipulation, which compromises data integrity. There are also concerns with limited storage and electronic signatures. A hosted EDC solution safely stores data and has designated roles for each user, which authorizes changes to be made by role-based access to data.
3. Errors go unnoticed.
While you can use basic data validation in Excel with various formulas, data entry errors can still easily go unnoticed. There are several types of data errors in addition to misplaced, lost, or omitted data. Even though using Excel usually saves time up front because staff already use the program and therefore do not need to be trained, a significant amount of time can be wasted on consolidating files and checking for errors. An EDC system allows you to build constraints into forms. If data is entered and doesn’t meet the criteria you specified, the system generates a query. An EDC system also ensures that queries are resolved and multiple steps are taken to verify, lock, and freeze the data.
4. No central location for forms and data.
Spreadsheets can be difficult to locate if they are saved to several files and folders. Often times important information is scattered and multiple copies of a document are created. If you’re still using spreadsheets, it’s very possible you’re also using additional applications to store and share data. An EDC system organizes and houses a central repository of forms, allowing them to be reused across multiple protocols. This eliminates the need to recreate commonly used forms and promotes the standardization of CRFs. EDC software also makes it easy to identify which is the most up-to-date version of a form.
5. Inefficient workflows.
Spreadsheets are not sophisticated enough to manage clinical data and can disrupt natural workflows. Recreating newer versions of a form can happen often in clinical research, which isn’t easy to deploy in spreadsheet format. Similarly, there is no efficient way to resolve queries using spreadsheets. An EDC system is designed to have a very logical flow for everything from form creation to query management. It also streamlines communication between monitors, data managers, and coordinators.
Spreadsheets are used in almost every discipline. While they can provide enough functionality for certain tasks, they don’t have the technical controls in place to collect, store, and verify clinical data. There are high risks of noncompliance, compromised data integrity, and data errors, in addition to spending too much time on locating and cleaning up data. EDC software is specifically designed to solve these problems and more. There are many reasons why organizations don’t go back to spreadsheets or other methods of data capture once they adopt an EDC system.