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Question:  Should we submit our ethics application as one study or two seperate studies to the REB for the RCT and the Registry?


Answer: This is up to your site and depends on what your REB/IRB prefers. We have submitted the RCT & the Registry as seperate studies since the Registry did not need full board review and the process is much faster for initial review and for any amendment. 

Question:  For the RCTs is it mandatory to start 1st line treatment in hospital?


Answer: No, in the study protocol it is only recommended to start treatment in hospital as we are aware that this is not standard care at all centres. 

Question:  Will the Sponsor reimburse us for pharmacy/drug costs?


Answer: Yes, But you will receive this as per patient reimbursements paid out at enrollment and at data completion. The per patient reimbursements are to be used to pay for relevant study costs at your site such as REB applications, pharmacy, coordinator time etc. The reimbursements have also been increased in order to support sites better for the health authority regulated RCT study. 

Question:  How can we get our research pharmacy to reduce their estimated costs for the RCT?


Answer: For those requesting a pharmacy review and costing for the RCTs here are a few tips already shared with some centers:

  • make sure they count the 3 sub-studies as one study and don't charge you 3x the administrative costs

  • mention to them that patients who need their medication changed (to a different drug) will go back to clinical care and medication will be dispensed as in normal clinical care and not paid for by research funds

  • in the protocol it says there are 25 possible encounters that can be entered in REDCap - make sure they realize this is an extreme case and not the norm as most patients will not have that many encounters (will vary depending on the drug and the frequency of visits at your site - PI can indicate an average)

  • please contact us if you require tips for what to do to decrease costs - for example you may be able to have an "emergency kit" for after hours dispensing (if approved at your site)

  • you can decrease dispensing costs by dispensing more meds each time (especially when meds are cheap such as in the case of Digoxin)

  • if you will not be using IV Digoxin - make that clear to pharmacy when they are preparing the quote



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