This message was posted by a user wishing to remain anonymous

My company is about to begin an open label trial on a high risk medical device against a competitive device.  While the trial is open label, we've committed to treat the data as though it were from a blinded trial.  We will have personnel present for each use of the device and have a link from our clinical electronic record system and our complaint system that will automatically alert the complaint group to adverse events and device malfunctions reported by the clinical sites.
It's my understanding that under 21CFR812, we need to capture complaints:

IDE Records

• Sponsor Records for Significant Risk Device Studies

The sponsor must maintain accurate and complete records relating to the investigation under §812.140. These records include:

• ...
• records concerning complaints and adverse device effects whether anticipated or not
• ...

We are having a lively debate about how to treat the data as blinded, but still collect complaints to comply with 21CFR812 with our clinical team insisting that the data cannot go beyond the few people unblinded in the study.

I am looking for any insight/suggestions people may have regarding this.

Yes, you do need to worry about AEs and Complaints reporting.  My only suggestion would be to limit it to one specific complaint person or to ​train one of the "in the know" clinicals team to do the reporting.

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Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
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Original Message:
Sent: 05-Dec-2018 12:12
From: Anonymous Member
Subject: Complaint Handling for Medical Device in Blinded Clinical Trial

This message was posted by a user wishing to remain anonymous

My company is about to begin an open label trial on a high risk medical device against a competitive device.  While the trial is open label, we've committed to treat the data as though it were from a blinded trial.  We will have personnel present for each use of the device and have a link from our clinical electronic record system and our complaint system that will automatically alert the complaint group to adverse events and device malfunctions reported by the clinical sites.
It's my understanding that under 21CFR812, we need to capture complaints:

IDE Records

• Sponsor Records for Significant Risk Device Studies

The sponsor must maintain accurate and complete records relating to the investigation under @812.140. These records include:

• ...
• records concerning complaints and adverse device effects whether anticipated or not
• ...

We are having a lively debate about how to treat the data as blinded, but still collect complaints to comply with 21CFR812 with our clinical team insisting that the data cannot go beyond the few people unblinded in the study.

I am looking for any insight/suggestions people may have regarding this.