In general, it would compromise the scientific method and integrity of the study if a study participant also approves the study. However, it is acceptable that a study participant review and give concurrence that the study accurately represents what the participant did or said. But it would ultimately be a conflict of scientific interest if a study participant also approves the study analysis and conclusions.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 29-Jun-2023 07:48
From: Naveen Agarwal
Subject: Clinician approval of Formative Study
Hello
In principle, the record(s) created by the formative study should become part of your DHF and/or risk management file. Those authoring and approving these records should be "competent" in their role related to the study.
In my view, a clinician's perspective is important. If they were an integral part of the study, they should be recognized as such. If your concern is that they are an external party, you could have them submit an official report approved by a person of authority in your organization. This report should become part of your controlled documents. You can include this report by way of reference in your final study report, which should also be a controlled document.
If the report author is "competent" in interpreting the clinician's observations, you may not need to do this. Keep in mind, competence is more than training.
Finally, the external party should be competent and you should have records reflecting your evaluation and selection process for them.
Hope this helps.
Best regards
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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
Original Message:
Sent: 28-Jun-2023 04:27
From: Anonymous Member
Subject: Clinician approval of Formative Study
This message was posted by a user wishing to remain anonymous
If a Clinician was involved in conducting a formative usability study, would it be necessary or recommended to have the Clinician sign off or approve the formative usability report? Particularly, if there were clinical or other observations noted by the clinician during the study, and the report author is interpreting these observations through notetaking from the study and review of the study videos/audio material. The Clinician is an external consultant to the organization but was trained on the formative usability protocol prior to executing the study.<o:p></o:p>