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Compliance In Focus
Posted by Kelly Schindelholz on Fri, Oct 4, 2013

What Do I Do When Source is Incorrect?

In general, most hospitals and clinics use electronic medical records (EMR), or a mix of Source Documentationelectronic and paper medical records.  Often paper records are scanned into the EMR in order to house all records for a particular patient in one location.

As a monitor, what do you do when the information provided in the EMR is incorrect? Consider how the integrity of the data reported for the research study may be affected. 

Case Study:  You are monitoring a subject for a medical device study; you note that the subject had hernia surgery two weeks prior to enrollment.  In the protocol one of the exclusion criteria states: “the patient has had any surgery within 30 days of enrollment in the study.”  You discuss the finding with the PI and he tells you that the subject actually did not have the mentioned hernia surgery because it was canceled but mistakenly dictated in the subject’s records.

Here are some ways a monitor could suggest to the site to document the discrepancy:

  1. If the system allows for it, have the site log into the EMR and correct the dictation electronically, reprint the record and file in the subject’s file.
  2. Have the site correct the mistake on the printed electronic record filed in the subject’s file, date and initial it. A best practice recommendation would be to have the investigator make these changes.
  3. Document the discrepancy in a note-to-file and attach it to the printed record in the subject’s file.  Again, requesting the investigator sign the note-to-file may be recommended by the monitor.

Looking to Good Clinical Practice guidelines, a monitor is tasked with ensuring that:

“Source documents and other clinical investigation records are accurate, complete, up to date, stored and maintained appropriately, and

CRFs and queries are complete, recorded in a timely manner, and consistent with source documents” (ISO 14155 8.2.4.5).

From this international standard for good clinical practice in medical device studies, it seems that the best action would be to correct the source record if possible. However, if the research coordinator is unable to do so, the monitor could recommend thorough documentation of the discrepancy by the coordinator and the investigator.

How would you have your site document this?

Photo Credit: James Sarmiento

 

 

Topics: ISO 14155, Electronic Medical Records, Source Documentation, Clinical Monitoring

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