Top 5 Problems With Using Spreadsheets to Collect Clinical Data Spreadsheets are very basic of a tool to maintain the increasing complexity of clinical trials. Here we write about 5 reasons to stop using them. For many people Microsoft Excel is a free and familiar tool. Spreadsheets are used for a wide range of projects, but they are far from ideal when it comes to data capture in clinical trials. Originally Excel was not created to build case report forms (CRFs) or to verify patient data that is collected in clinical trials. In spite of the technological advances in software solutions, many organizations still opt using spreadsheets. Here are five problems with using spreadsheets to collect and store data from clinical trials.
1. Lack of compliance.
If you submit your clinical trial data to the FDA, there are a number of regulatory requirements to meet such as 21 CFR Part 11. One necessary aspect is traceability of any and all the changes that are made to data. In an electronic data capture (EDC) system this is possible with audit trail functionality. If someone make changes of values in a spreadsheet, the history of who created the change, the date and time the change was made, the entered old and new values , and the reason why the change was made are not available. You simply cannot trust something that you cannot track.
2.Data is not secure.
Spreadsheets have quite a limited permission controls when it comes to confining access for multiple users. This lack of protection can lead to data manipulation, which compromises the data integrity. There are also concerns with limited storage and electronic signatures.
3. Errors are not noticed.
Though you can use basic data validation in Excel with various formulas, data entry errors can still easily go unseen. There are different types of data errors in addition to misplaced, lost, or omitted data. Even though utilizing Excel usually saves time up front because the staff uses the program and therefore do not need to be trained, a certain amount of time can be wasted on consolidating files and checking for errors.
4. No central location for forms and data.
Spreadsheets are difficult to locate if they are saved to several files and folders. Often times important data is scattered and multiple copies of a document are created. If you’re still using spreadsheets. An EDC system organizes and houses a central repository of forms, permitting them to be reused across multiple protocols. This eliminates the need to recreate commonly used forms.
Spreadsheets are not sophisticated enough to manage clinical data and can disrupt natural work-flows. 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 developed to have a very logical flow for everything from form creation to query management. It also thins 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.
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