Microsoft Excel is a free and a very familiar tool for all of us. Spreadsheets are used for a wide range of projects, but they are far from ideal when it comes to data capture in clinical trials. Excel wasn’t created to build case report forms (CRFs) or to compare and verify patient's data that’s collected in clinical research. Despite technological advances,many organizations still cling to spreadsheets.
Here are five difficulties using spreadsheets to collect and store data in clinical trials.
1. Lack of compliance
If you’re planning to submit your clinical trial data to the FDA, there are many regulatory requirements to meet such as 21 CFR Part 11. One important element is traceability of any or all changes that are made to data.
In an EDC; electronic data capture system this is possible with audit trail functionalities. If someone changes a value in a spreadsheet, the history of who made the changes, the date and time the change was made, the old and new values entered, and the reason why the changes were made are unavailable. You simply cannot trust something that you cannot track.
Spreadsheets have very restricted permission controls when it comes to restricting access for multiple users. This lack of protection can lead to major data manipulation, which compromises data integrity. There are also concerns with limited storage and electronic signatures.
3.Errors go unnoticed
Since you can use basic data validation in Excel with various formulas, errors in data entry can yet go unnoticed easily . There are several types of data errors in addition to misplaced, lost, or deliberately deleted data. Though using Excel usually saves time up front because the staff already uses the program and therefore no training is required, a significant amount of time can be wasted on consolidating files and checking errors.
Whereas an EDC system allows you to construct constraints into forms. If data is entered and doesn’t meet your specified criteria, the system would generate a query.
4.Forms and data have no central location
Spreadsheets are difficult to locate if they are saved to several files and folders. Often times important informations are scattered and multiple copies of a document get created. If you’re still using spreadsheets, its quite obvious that you’re also using additional applications to store data and share them.
An EDC system organizes and houses a central computation of forms, allowing them to be reused across multiple protocols. This definitely eliminates the need to create commonly used forms again and again and promotes standardization of CRFs.
EDC software makes an easy identification of the modified and most updated version of a form.
Spreadsheets are not advanced enough for clinical data management and can disrupt natural work-flows. Repeated creation of newer versions of a form can happen often in clinical research, but this isn’t easy to deploy in a spreadsheet format. Even there is no efficient way to resolve queries using spreadsheets.
Whereas an EDC system is designed to have a very logical flow for everything from creation to query management. It also streamlines communication between monitors, data managers, and coordinators.