Activity

  • In order to prepare a schedule and budget for a clinical trial there are several factors to consider.
    The schedule of clinical trials is basically an outline that contains all the activities that will be performed during the clinical trial. This schedule serve as a plan that will allow sites to strategically and smoothly conduct a study. Look at it as a cheat-sheet that will allow you to conduct every protocol in a better and more organized way. The structure of the schedule of assessments will always depend on the study. Every study is different and it has different requirements, which means that every schedule of assessments will definitely not be the same. A clinical trial schedule will contain the following elements (as an example): screening phase, treatment phase, and follow-up phase. Each phase will contain details of activities such as number of visits subjects will perform, frequency/ timing, etc.
    Budgeting is very important for clinical trials just as we have seen for project management. Without a properly negotiated and prepared budget, the investigator and the institution will lose money on a clinical trial. Because a clinical trial contract is a fixed-price agreement, the investigator is obligated to perform the work described in the contract, even if the actual costs exceed the total contracted amount. The sponsor may initially quote a budget amount allocated to each site, or may ask the investigator to develop a budget for review. In the case of a sponsor-determined budget, the quoted amount may be adequate or generous, but this is often not the case. In most cases, a reasonable compromise can be reached after performing a cost analysis and reporting those calculated costs to the sponsor. However, on occasion it may be necessary for the investigator to turn down a clinical trial because of an inadequate budget offer. Equally important are the terms of the payment schedule. Consider when payments should happen and whether it makes sense with the timing of procedures in the study.
    https://www.childrensmn.org/downloads/2015/11/aboutus.research.clinicaltrialsbudgeting.pdf