In this 2-minute video, clinical trial subject matter expert, Jery Grupp, draws on his rich background which includes selecting and managing clinical systems at Merck and Janssen, to talk about the importance of validation and how paper and eCOA are different when it comes to providing study teams with all the information.
Data integrity and validity have got to be the number one concern for anybody who is gonna be gathering data from subjects.
When we look at paper versus eCOA, eCOA has the virtue of every aspect of touching that data, from the time the subject enters the data straight through to the time it’s produced into the ultimate clinical study report, every step along the way is defined and controlled by a system. We know the path of the data, we have all the metadata with the data, we have the full audit trail of the data. Every step along the way is verifiable and is validated.
So, in a paper situation, you don’t know when they completed it, you don’t know who completed it, and what do you do when someone writes notes on the corner or in the margins? Are those important? Are those unimportant? How do you handle those?
With an eCOA situation or an eDiary situation, the subject is more tightly constrained. We know when they entered the data, we know who they were because they logged on with a unique IP and password, and they answer the questions as they’re defined.
It also means that the questions follow a hierarchy and they’re guided through. We can ensure that subjects don’t skip a question.
Someone who hasn’t been completing the diary, you don’t know until they come back, if it’s a paper diary. You have that opportunity to correct their behaviour or get in touch with them to enhance their behaviour and enhance their compliance, because you monitor remotely, if you’re working with an eDiary solution.
As a sponsor my obligation is to provide clean, accurate data to the regulators to support my claims. Anything that would give me clean data, faster data, and with a better traceability is gonna be something that I’m gonna be interested in.
All the steps within eCOA provide you with quality data, timely data, validated data, and data that is contemporaneous. Paper, it’s always had open question about it, it always will have open questions about it.
And for that reason, I think that when you look at eCOA versus paper, the case is clear.
About the AuthorFollow on Linkedin More Content by Jerold Grupp