5. QIU- Qualified Investigator Undertaking form- Canadian sites
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/form/qual_invest_under_form-eng.php
It is really important not only to have the form completed but also ensure it is done correctly. Question for you, have you actually read the document that you are sending to the PI and having them sign?
Do you know what the PI is signing? Does the PI know what they are signing?
“QIU Statement: In respect of the identified clinical trial, I certify, as the qualified investigator for this site that:
• I am a physician or dentist and a member in good standing of a professional medical or dental association as defined in Part C Division 5 of the Food and Drug Regulations;
• I will supervise the medical care and medical decisions respecting this clinical trial at this site;
• I will conduct this clinical trial in accordance with Good Clinical Practices; and
• I will immediately on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the Research Ethics Board for this site of the discontinuance, provide them with the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons.”
Having read these points, they agree to follow the protocol, follow GCP, and oversee the conduct of the clinical trial.
This is very imortant! We will talk about PI oversight again in another blog post. Over the years, it is incredible what we see as PI oversight. It deserves its own post.
Here for the QIU, it is important to hold the PI accountable and responsible for the agreement they have made to the sponsor, Health Canada and the clinical trial subjects and lastly the Research Ethics Board.
Why would we do this? If not done, the data collected may be called into question. You don’t want your site to be the one where they compare the aggregate data with and without that sites data, for a breach of this agreement.
Next post will discuss the FDA1572 form