Did you know it is part of GCP and Good Documentation Practices to leave no blanks on your source documents and CRFs?
These can be (but are not limited to!), smart phrases w/ fill-in blanks, flowsheets for dosing/lab draws/etc., AE/DOA/ConMed logs, ICF’s, patient diaries, paper and electronic case report forms (CRFs), etc. See ICH GCP E6 (R2) 1.51, 1.52, and 4.9 for further details.
Why do we have to do this?
It makes the documentation complete. Blank fields need clarification so data cannot be recorded “after the fact.”
It makes it clear that item was not just missed or inadvertently not documented.
It can fill the gap to explain why something was not done.
It shows who did the documentation.
It can help you identify if something was missed and promptly get it reported as a deviation (or possibly even resolved if caught within window!).
It closes out logs that are completed or no longer in use.
It ensures all information needed, like headers, pt. information, etc. are present on the forms.
Provides data integrity by showing all data was recorded or why it was not recorded which…
Helps YOU with managing the study by knowing why the blank is there and not having to look back to see if there was actually data to fill field and cuts down on the pile up of needing to do it later.
And many more!
How should this be done?
Marking through with a single line and writing “Na”, “ND,” or list the reasoning for the cross out of the blank. Remember to initial and date to record the audit trail of the change!
Assess if there are items that are often left blank, if so consider revising the forms used, if possible, to eliminate the amount of blanks left.