Good day Anon,
The simple answer is yes, you would want to clearly identify clinical investigations which are under the prevue/control/management of the company and those which get published in clinical literature or journals. Usually what I do is in the Clinical Evaluation Report (CER) have a separate section for "clinical investigations" where these are clinical investigations managed by the company. You are correct, usually the clinical investigation protocol and clinical investigation report can then be referenced by the CER (kept these in the document control system as well) providing much more detail. Then during the clinical literature search, the journal which is reporting the clinical investigation can show up again or the company may already know the publication information. What I do then is make a clear indication in the analysis section that these two are related. Meaning, in the clinical investigation summary make a note the trial was published as "Title" by Author, et. al., etc. Then in the clinical literature summary make a note Article # is the published part of Clinical Investigation 999. Strongly recommend putting these put in the CER and linking them together in some way.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-May-2023 11:59
From: Ronald Boumans
Subject: Reporting cclinical investigation results in a Clinical Evaluation Report
The word 'sponsored' is a bit ambiguous here. It could mean that the manufacturer is the sponsor, as defined in the regulations. In that case, these would be manufacturer-owned investigation results and they should be discussed in the appropriate section. The publication should also be listed, but the results should only be counted once for the final evaluation. If you mean that the manafucturer helped for example an investigator initiated study by providing devices for free (this could be seen as 'sponsoring' as well), I would treat this publication as any other publication, with a note that the devices were provided for free.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 12-May-2023 05:07
From: Anonymous Member
Subject: Reporting cclinical investigation results in a Clinical Evaluation Report
This message was posted by a user wishing to remain anonymous
Dear All,
I am wondering when a manufacturer-sponsored clinical investigation resulted in a publication, does the manufacturer besides reporting the publication which will show up in a literature search, need to also discuss the clinical investigation itself within a Clinical Evaluation Report? I assume both need to be included in the CER, especially since the clinical investigation plan/report contains more details on the study conduct as compared to published article.
Thanks!