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ForumTopics: Budgets/ContractsOH justification and contract ter …

OH justification and contract terms

brad@brad

184 Posts

#1 · May 5, 2022, 2:31 pm

Just wanted to share our letter for OH justification and try out the file upload feature on the forum. Open to hearing others techniques as well.

Uploaded files:

OHJustification.pdf

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"

OutdatedECG@adam

12 Posts

#2 · May 6, 2022, 12:21 pm

This is exactly the type of transparency we need. Thank you for sharing this Brad, I'm going to show it to my site director.

What percentage of studies would you say turn you down as a site after showing this letter?

brad@brad

184 PostsTopic Author

#3 · May 6, 2022, 1:28 pm

Quote from OutdatedECG on May 6, 2022, 12:21 pm

This is exactly the type of transparency we need. Thank you for sharing this Brad, I'm going to show it to my site director.

What percentage of studies would you say turn you down as a site after showing this letter?

Nobody turns us down but we may still have to negotiate the OH, ending up at 35%. We can live with it. Just starts the negotiation high so we have a little room to play.

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"

Guest

#4 · May 13, 2022, 11:33 pm

Quote from brad on May 6, 2022, 1:28 pm

Quote from OutdatedECG on May 6, 2022, 12:21 pm

This is exactly the type of transparency we need. Thank you for sharing this Brad, I'm going to show it to my site director.

What percentage of studies would you say turn you down as a site after showing this letter?

Nobody turns us down but we may still have to negotiate the OH, ending up at 35%. We can live with it. Just starts the negotiation high so we have a little room to play.

Starting 2021, we upped our OH to 44%. This year its 47.5%, and next year we've already confirmed we are going to 50.3%. Let it escalate, and sponsors will pay. Keep in mind they OH they are comparing you to are from academic universities, who get state dollars to subsidy their operations. Gas prices and electric bills aren't getting any cheaper, and you need to make sure you are keeping your lights on.

Guest

#5 · May 13, 2022, 11:39 pm

Quote from brad on May 5, 2022, 2:31 pm

Just wanted to share our letter for OH justification and try out the file upload feature on the forum. Open to hearing others techniques as well.

You spell it right out, and I love the non-negotiable payment terms included in the letter in the event there's ever a question.

We like to include in our letter " "A non-negotiable Institutional Overhead (OH) charge of XXX minimum is assessed on all per-patient budget proposals, pass-through expenses, and invoiced expenses to facilitate the Clinical Resaerch Department's necessary office, personnel, and administrative activities. This charge rate is subject to change according to sponsor requests that incur additional financial risk/burden to the site (quarterly vs. monthly reimbursement, required contractual withholding, etc.). "

Also, we established in our SOPs and institutional policies no trials will be approved if they are underfunded. That way the site sets a quality standard to ensure trials have what they need to be performed properly.

Guest

#6 · September 14, 2022, 10:42 pm

Do you have a sample SOP which discusses the underfunding of trials?

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OH justification and contract terms