Electronic Records - leave non-mandatory fields blank?

[Ajit Basrur]

For electronic records, is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

 

[ChrisM]

I was taught that a blank field could mean that someone forgot to make an entry, so an otherwise blank field should have a line through it, or "N/A" or "none" etc recorded to show that there was no requirement to fill it in.

 

[yodon]

Completely agree with @ChrisM. Just a short add to it: you also don't want to enable anyone to come in behind and fill in those fields. (Hopefully the date / time stamps could be used to attribute all changes, but you don't want to rely on that.)

 

[Tidge]

For electronic records, is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

We leave non-mandatory fields blank all-the-time on electronic submissions during complaint reporting to regulatory authorities. There are no "N/A", these fields are simply left blank. We keep a non-editable record of what was submitted, and there is an audit trail on the record. If information needs to be updated we file (again electronically) updated records.

 

[EmiliaBedelia]

We leave non-mandatory fields blank all-the-time on electronic submissions during complaint reporting to regulatory authorities. There are no "N/A", these fields are simply left blank. We keep a non-editable record of what was submitted, and there is an audit trail on the record. If information needs to be updated we file (again electronically) updated records.

IMO this is different, as there is no opportunity to amend the record later as Yodon said. For an electronic interface or portal that creates a record stored somewhere else, you would be forced to follow the data validation rules that the system enforces, regardless of whether it would be best practice to use "n/a" or not. GUDID for example has very annoying rules about blanks, nulls, N/A, etc.

Personally on forms or internal records, I would just use n/a to be safe. If I were so busy that I didn't have time to enter "n/a" in blanks... I wouldn't have time to be posting here either

 

[Tidge]

The man asked for an example; an example was provided (with rationale).

Inserting "N/A" is deriving from a paper-to-electronic way of thinking. A paper form has no idea if it is "completely" filled out (with-or-without "N/A"); writing "N/A" in every conceivable spot is simply a manual attempt to demonstrate consideration (of the area hand-marked "N/A"), while also being a crude future-proofing a completed form in the event it is is later revisited. There are rules about "audit trails" on paper documents too.... and audit trails is an area that 21 CFR part 11 focuses on, not on "inserting N/A". FWIW, 21 CFR 11 rules apply to incomplete electronic records as well as complete ones.

 

[Ajit Basrur]

I agree with all comments on not to leave it blank. It is totally understandable and is maintained for paper records. However with OTS software, it may not be possible all the times. So we are planning to proceduralize that mandatory cells "must" be filled.

 

[Hi_Its_Matt]

So we are planning to proceduralize that mandatory cells "must" be filled.

If you expect something to be placed in a field, even if that something is "This field is not applicable," then I would make it a mandatory field. Fields should be optional only if there is truly no expectation for a response.

Furthermore, "this field is not applicable" without any further justification should be accepted only if it is painfully obvious to all parties involved that the field is truly not applicable. And in that case, a blank field should be just as obvious. If there is any doubt as to why "n/a" was put, or why the field was left blank, then justification should be provided. And in that case, not to be pedantic, but the field is no longer truly optional, it's a mandatory field that just may not apply in all situations.

Lastly, I'm not sure about where you work, but at most places I have seen, writing a requirement in an SOP or WI isn't enough to change behavior. So if you plan on making it a procedural requirement to fill "optional" fields, without having automated controls in place to detect and prevent blank fields, then I hope you all are also planning on (1) robustly training people on the new requirement, (2) assigning a human "gate keeper", who is specifically responsible for looking for blank fields, (3) sending a bunch of mostly-complete records back, just to have "N/A" filled in, and (4) eventually documenting and dealing with the nonconformities to the procedural requirement, when it is inevitably violated and missed by its human gatekeeper.

 

[ChrisM]

You don't need a "blank field gatekeeeper", just adequate training at all levels and periodic reminders as necessary to those authorising/signing-off "completed" forms that their review must include making sure that no fields are left blank. If necessary this person can add "N/A" or draw a line though the box (and remind those who forgot to complete the blank boxes)..... I've done this in at least two of my previous jobs; it's all about working together for minimal pain and maximum gain

 

[FRA 2 FDA]

Regardless of requirements, I am in the camp that it's best practice not to leave things blank. It is a very real-life situation where I review completed forms and find blanks that could either mean "there isn't any information to add here" OR could mean "I forgot to fill this in and there is/could be important information left out". Also in the situation of historical information- if you encounter a situation where you have to got back to records to find out why a decision was made or what was done the last time, etc and something is left blank, how can you know if anyone actually considered this or if it got missed? Is it blank because it wasn't needed or is it blank because someone forgot to fill in a reference that could be very helpful or because it was missed back then and never considered/ carried out? I say no blanks ever (unless the field indicates that information should only be there if another field indicates something and all it takes is seeing on that very form that the information is not applicable).