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.

1. Problems In Using Spreadsheets to Collect Clinical Data

2. 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.

3. 2.Insecure data
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.

4. 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.

5. 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.

6. 5.Inefficient work-flows
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.

7. There are plenty of reasons why organizations don’t go back to
spreadsheets or other methods of data capture once they adopt an EDC
system.
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8. Thank You !!