Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
Riddle me this: Why is an eMDR not a true electronic equivalent of a Form FDA 3500A MedWatch report?
Do you know the answer? If you don’t — that is, if you didn’t respond, or your mind went blank on this riddle — well, then you’d technically be correct. If this still isn’t making sense, you’ll understand by the end.
You see, aside from the obvious answer that one is a fillable PDF form and the other is an electronic XML file, there also are distinctions regarding the acceptable manner for leaving fields blank when you have “nothing” to answer.
The MedWatch report (Form FDA 3500A) has many fields which can simply be left completely blank. Its electronic XML cousin, eMDR, has different options for empty fields, and these are called null values. As a best practice you should always enter one of the standard null values noted below rather than leaving a field blank. Let’s take a closer look at your null value options.
4 ways to report an empty field or null value on an eMDR
By August 14, 2015 (a mere few months ahead), you will need to be submitting the MedWatch reports electronically. So learn these 4 ways to say “nothing” in your reporting, ensure you’re in compliance with the final rule, and get ready to correctly submit “nothing” in your mandatory reports.
1. ASKU = Asked but unavailable
Sometimes you might be asking the right questions or conducting thorough investigations, but not getting any answers. In these cases, you should use the ASKU code in the field.
2. NI = No information
When an answer could hypothetically be available but no information was provided, you should enter NI in the particular data field.
3. NA = Not applicable
Some fields are not applicable to all adverse events. Depending on the type of event, and the data available, you may need to default to the classic “not applicable” or NA.
4. Actual code value
While options 1-3 above are true null value codes for the XML, this last one is a bit more complex. Depending upon the field in question, there are actual code values to indicate “unknown.” When this is the case, the code value should always be used. For example, in the F10 problem codes field, code 2204 should be used instead of a null value (ASKU, NI, or NA). This concept is very similar to choosing the lowest CDRH code available, which is always a best practice.
There are three fields that should can never be left blank or entered as null. If you do, your record will be rejected. Every eMDR must include:
- A report number,
- An event description (B5), and
- Type of device (D2).
Congratulations! You now know a lot about nothing! And if your mind went blank when I initially asked about the difference between Form FDA 3500A and eMDR, you were right — the difference is in the handling of blanks.
Now you know the difference between Form FDA 3500A and a traditional MedWatch, and how to handle null values in your eMDR file. To further help you on your path to eMDR success, check out this e-book on eMDR success.
If you have any questions or topics you’d like to see covered in future posts, please let us know in the comments below.
Courtesy of Pilgrim Quality Solutions
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