What Is A Master Clinical Trial Agreement

The use of Master Template Agreement can significantly expedite the conclusion of contract negotiations for a clinical trial. Master`s agreements generally require intensive negotiations, as their conditions must be acceptable for all clinical trials submitted to them. A master`s contract can take years to negotiate and conclude, but it is generally valid three (3) to five (5) years after signing. It is very difficult to change the terms of a master`s contract after being executed by all parties. At the end of a clinical study, a cash credit may remain. If the expenses incurred for the study are reasonable in relation to the projected costs and all costs (direct and indirect) have been properly billed and documented, the cash is made available to the auditor, but belongs to the division. Yes, for example. B, an auditor leaves the institution, he must obtain the authorization of his head of department before funds can be transferred to the new institution. The project may also be deactivated and the remaining balance sheet transferred at the examiner`s official request at the end of the study on another 48002 project.

INDIRECT COSTS Indirect cost for human clinical trials and all other industry-supported studies are valued in lump sums at 30% of the money actually received. To estimate indirect costs when direct costs are known, add 30% of direct costs. The sum of these two numbers is the pro-patient quantity. For example, if $1,000 is needed to cover direct costs, 30% or $300 must be added for an indirect cost, bringing the amount to $1,300 per patient. A first payment may be equal to or included in the cost per patient of a subject or may be a separate item for start-up costs. If a first payment is based on the cost of a subject, the promoter may require that subsequent payments be reduced by that amount in order to recover those fees. From time to time, the proposed contractual terms indicate that the first payment is sent only after a subject is randomized. This situation is not acceptable. The PSO only implements your project/subsidy after receiving a payment from the sponsor. If a subject is never randomized, no payment will be received; however, the study entails costs that are not reimbursed.

Instead, the auditor should require an appropriate upfront payment to cover start-up costs. This amount should be sufficient to cover all costs associated with launching a study (including the IRB fee) if the trial never begins. Look at your milestones for payment. Do you get paid after filling out the application forms? This may mean waiting for the monitor to check the CRFs and send them into data management. Are you paid at the end of a trial participant?` This can delay payments. An ideal schedule is reimbursed after a reasonable number of subjects have been randomized or after a certain number of visits have been made, so that your study account does not work in deficit. Sponsors can also withhold a significant portion of the payment until all study activities are completed. Make sure it is not an excessive amount. 10% of the total budget would be ideal. The final payment may depend on the closure of all websites or the closure of the study database.

Be careful, as this may mean that final payments may be delayed for an undue period. INSURANCE To support the above compensation, the sponsorship company must maintain a sufficient level of insurance.

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