By Beth King, Director, Cardiovascular Research, UP Health System – Marquette
Q: What empowerment best practices or techniques does your site do to ensure mutual alignment between your site and sponsors/CROs?
A: We do a few things.
1. Request CRF samples prior to time and effort assessment
I typically request these when I get the contract and budget, and explain that it’s important to know more precisely what CRFs entail in order to complete an accurate budget assessment. The EDC doesn’t have to be ready, but I ask that they send any developed data collection worksheets, or even source docs, and documentation (like the required medical history detail, which can vary in depth and length, or requirements for concomitant medication collection).
I want to know, for example, do we need to collect and data enter all concomitant meds, or just cardiovascular/HF-related? Do they want dose, start and end dates for everything? Do they require collection of all medications during hospitalization, catheterization, surgery, etc.? These variations of what’s expected for data collection can impact the time and effort required, so having as much detail as possible is important for an accurate time and effort assessment to use in the budget negotiation. I also ask for samples of required questionnaires, as they may involve considerable time for data entry, even if the subjects fill them out themselves.
I just try to get as much specific information as I can to be able to judge time and effort. For some sponsors with whom I have done multiple similar studies, I can ask if they expect about the same data collection as a prior study. I also ask what they are providing (worksheets, recruitment letters to subjects or PCP, source docs, etc.), as that can really affect the start-up time.
2. Include study coordinators in reviewing time and effort based on protocol requirements and CRFs
I create a detailed spreadsheet of every single activity – from screening time based on how many people we may need to screen before locating an eligible patient to how many calls/contacts to get an agreement. Sponsors are often doing their own itemized time and effort assessments using their assumptions. They do not usually include the ancillary activities required (e.g. screening efforts, calls or letters to patients for recruitment, scheduling, etc.). They often just use the time to complete the EDC, but there is always data collection on worksheets or source docs that may take a lot of time depending on where and how you need to locate the information.
Once I have a ballpark figure in a clearly itemized spreadsheet of anticipated T&E, I give that to the primary study coordinator to review and edit. I am not directly involved in the day-to-day operations of recruitment and data collection, so it’s really the study coordinators who have the best knowledge from recent or ongoing studies to accurately assess the time and effort required. We keep working to make these estimates as close as possible.
Then, I provide the sponsor the detailed spreadsheet with everything itemized. In this, I include comments explaining activities for which our request is much higher than they’ve proposed, or was completely absent in the sponsor proposal.
3. Provide detailed time and effort assessment with budget request, including start-up activities
The itemized spreadsheet that provides costs for all staff for various items is the format for justification best received by sponsors. For instance, I use my salary for items I will be doing, like reviewing the protocol, and mine or my data manager’s for setting up a tracking system, the budget analysis, contract negotiation, among others.
Sponsors often don’t include time for activities such as training the PI, all sub-Is, and all study coordinators (we have 4-5 that are cross-trained), or the time it takes to attend an investigator meeting (if that is an option or required). I often get twice the amount of start-up fees that are initially offered and 20 percent to 40 percent above on subject activities if the sponsor is at all open to negotiation. Some are not, but those tend to be appropriately funded, and I still try to negotiate if it’s too low. I am willing to walk away if I think we will lose money on it.
This post is part of the site empowerment campaign. To learn more about site empowerment techniques, you can find all of the articles here.