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researchbudget2There is nothing like the word “budget” to strike fear into the heart of a health professional.  As I explained in Part 1 of this series, there is no need for research budgets to be a scary exercise.  Once you have the Patient Payment down, the rest is easy peasy.  Part 2 will deal with the other costs you should be including in every single study budget.

Please note that this article was written for Australian research sites and some information may not be suitable for research sites outside Australia.

After working in research for about a year, I developed a “Schedule of Fees” for our research unit and have implemented it in every unit I have worked in since. The fact that I have had to implement this in every place I have worked worries me but that is another topic.  The “Schedule of Fees” is a list of fixed price fees that are included in every trial budget.  I generally revise once a year and increase with CPI.

So what should you include?  Here is a list of what I think is important to include in your budget:

  • Pass Through Costs – If anyone charges you a fee for part of the trial and that fee is not included in the per patient payment, it should be itemised separately in the study budget.  Most common examples are Ethics Committee fees, Governance Committee fees, hospital admission fees, pharmacy fees and radiology fees.  There may be others depending on the trial and how your institution works.
  • Governance fees: If your institution does not have a governance fee, you still need to include one in your budget.  This cover time taken to prepare the study budget, obtain quotes and, most importantly, seek legal advice before signing any contracts.  Most sites in Australia will use the Medicines Australia Clinical Trial Research Agreement (CTRA) but this should still be reviewed by a suitably qualified legal person to ensure it is suitable for use with your institution.  Any changes made to the template agreement should also be reviewed before signing.
  • Site Setup Fee:  This fee covers all activity from feasibility through to the SIV visit.  This fee needs to cover the cost of completing the feasibility, the Site Selection Visit, preparation of the Ethics submission, correspondence with the Ethics committee, communication with the Sponsor, attendance at the Investigator Meeting, training for the study, collection of Essential Documents and the Site Initiation Visit.  This is a lot of work – one study I set up had over 16 hours of online training to complete per person – make sure you set your fee high enough to cover your cost.
  • Annual Fee:  This is important to cover the work done for the study which is not patient related. It covers things like maintaining the Investigator Site File, teleconferences/webinars, monitoring SUSARs, reporting and follow-up of Serious Adverse Events, answering Sponsor questions, annual update of Essential Documents, patient recruitment activities, prescreening and screen failures not paid out by the Sponsor.  When I first started in research, 75% of my activity was patient related and 25% overheads.  Now the ratio has changed to 50-50 (in some cases the amount of overhead is actually higher than the patient-related activity).  The amount of regulatory oversight is increasing and the annual fee helps to defray the cost associated with this.
  • Close Out and Archiving:  This fee is to cover the close-out visit and archiving of the study for fifteen years.  Study files should be archived somewhere accessible and that is fire and water proof.  Most sites will use a specialist document archiving service.  Keep in mind that the fee they charge will increase annually and budget accordingly.
  • Subject Payment: Sponsors are very good at offering subjects (via the Participant Information Sheet) a small stipend to cover the cost of transport, parking and, sometimes, meals (if the visit is over four hours long).  However, they often forget to include this cost in the study budget.  Make sure you aren’t making promises to your patients that you can’t afford to keep.
  • Amendment Fees: Did you know the average number of amendments per study is now six?  There is a lot of work to prepare an amendment for ethics and governance review.  Not to mention retraining the entire study team, reconsenting existing patients, updating the Investigator Site File and other updates such as new lab kits, new eCRF pages etc.  Unless you can absorb the cost of preparing six amendments, you need to include this fee.
  • Unscheduled Safety Visits:  This may not be important for all sites but something to think about including.  Often, the Protocol will mandate a follow-up procedure for certain Adverse Events or after a dose modification.  This may include extra visits or extra procedures such as follow-up blood tests.  It is important to include a fee to cover this event.  Other sites are also charging a separate Serious Adverse Event reporting fee rather than including this in the Annual fee.
  • Audit Fee:  I know that every site should be audit ready but a lot of time is involved in having an audit team at your site.  Audits can last from a few hours to a week.  It takes up a lot of time from the study team and needs to be accounted for.  My opinion is that this fee should only apply to not-for-cause, sponsor-initiated audits.  For-cause audits are avoidable and, therefore, the site needs to take responsibility for these types of audits.  Regulatory body audits are uncommon in Australia and part of the cost of doing business.
  • Remote Monitoring Fee:  Remote Monitoring (not to be confused with Risk based Monitoring) seems to be “in fashion” at the moment.  Unfortunately, it takes a lot more time from study staff than onsite monitoring as documents need to be deidentified, faxed/emailed and involves a teleconference (or three).

Now you know what to charge for, how do you know if you are charging the right amount?  The Independent Hospital Pricing Authority is a good place to start.  The have a publication entitled “Development of a table of standard costs for conducting clinical trials in Australia” which is evidenced-based.  It is what I have used as the basis of my Schedule of Fees.  Once you set these fees, it is simply a matter of revising annually to make sure they are still viable.

And there you have it, all the tools to make a clinical research budgets easy.

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