When preparing the budget for a clinical trial, it needs to be flexible. If the trial goes over-budget, the sponsor must cover the cost. Budget items can be categorized in one of two ways: 1) fixed and upfront costs which are needed for study conduct and are incurred whether or not a subject is enrolled and 2) costs related to subject visits. In addition to budgeting for the study itself, the institute where the study is taking place needs to be budgeted for as well. Some factors here that need to be considered are what institutional approvals are needed and whether or not there are mandated fees charged.

Preparing a schedule for a clinical trial is done using the same tools that were used for others projects: by creating a WBS and a Gant Chart. The WBS should include pre-study tasks, study tasks, and post-study tasks layed out for the entire project. The pre-study tasks include a request for clinical evaluation, creating a clinical development plan, developing a schedule, negotiating investor budgets, identifying stakeholders, and preparing the budget. Study tasks include tracking the project schedule, resources and costs, and creating progress reports. Post-study tasks include creating progress reports, controlling the project, and close-out reports. All of these tasks can be laid out in the Gant Chart to assign the tasks to individuals, show dependencies between tasks, figure out task durations, and to find the critical path. The same project management techniques can be used to prepare the schedule and determine the budget for clinical trials as for other projects.

According to me preparing a budget is a major issue. It aims at preparing budget estimating costs and justify the costs necessary to perform goals. Steps for this are: 1) Estimated Costs 2) Justify the budget 3)Ensure Cost Effectiveness.

There are many factors to look for while preparing schedule and budget for clinical trials.

1. Start-Up Fees:
This Start-Up Fee includes all of the Internal Committee and IRB application preparations, budget negotiations, regulatory document preparation as well as on-site visits and study protocol training. It may also include the Pharmacy Start-Up, Pharmacy Close-Out, Record Storage and overall Study Close-Out.

2. Research Test Costs:
Even though the sponsor attaches a budget spreadsheet with the contract, you may be able to submit your own spreadsheet or add inline items not included in the budget spreadsheet the sponsor submits with the contract, ask the sponsor what format they require the budget in.

3. Personnel Time Expense to Conduct Study:
Consider the amount of time that a research team member will utilize in order to complete a visit. (informed consent, Inclusion/Exclusion Criteria Review, collecting vital signs, dealing with the sponsor,prepping for visits, prepping forms, subject visit contact, processing/shipping labs, Adverse Event review, Concomitant Medication Review, completing case report forms and entering data into the study electronic data base) and that research team member’s current hourly rate based on salary including fringe.

When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining expected enrollment. You need to determine how long the study will take?, Are you able to find a CRO will give you a reasonable cost for the study?. Also, it is important to account for hidden costs (like services/items not listed in the protocol), such as institutional review (IRB) review fees, advertising for recruitment, document archive and storage fees, close-out costs, inspections, and audits.

When preparing your budget for a clinical trial you need to first have a well defined schedule broken down. The schedule should be made first so you can see where money will have to be spent at certain times and then you can budget to make sure that you will have adequate money at that time. To prepare the schedule I believe you must allow ample time for all projects to get done. Rather than set a time table where everything must be done as quickly as possible and where poor results may than be produced, it is better to allow more time for pieces of the project. That way if anything you will be ahead of schedule not behind schedule and you are less likely to make mistakes or lose contractors or sponsors. To determine schedule you must also consider the members working in your project. You must ask questions first to get a judgment of everyone's availability and to see who will be away during what time. This will then allow you to predict how long projects and steps will take.

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol' study flow chart .other costs should be considered like cost related with shipping. Always take into account the hidden costs like time and cost related to CRF completion or reporting adverse events. Remember start-up costs, e.g, WIRB fee for initial review, Research Pharmacy setup fee, etc. Identify which procedures are standard of care and billable to third party payors, and which procedures are study specific and billable to the sponsor. Compare your trial cost estimate with the funding first offered by the trial sponsor. Negotiate with the sponsor to address shortfalls. In order to prepare schedule consider the length of the protocol, What is projected study startup timeframe, deadlines for items such as IRB reviews, enrollment activities . Team member availability for each tasks and about the communication details.

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol' study flow chart .other costs should be considered like cost related with shipping. Always take into account the hidden costs like time and cost related to CRF completion or reporting adverse events. Remember start-up costs, e.g WIRB fee for initial review, Research Pharmacy setup fee, etc. Identify which procedures are standard of care and billable to third party payors, and which procedures are study specific and billable to the sponsor. Compare your trial cost estimate with the funding first offered by the trial sponsor. Negotiate with the sponsor to address shortfalls. In order to prepare schedule consider the length of the protocol, What is projected study startup timeframe, deadlines for items such as IRB reviews, enrollment activities . Team member availability for each tasks and about the communication details.

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

Developing the schedule and determining the budget are done during the planning phase, before initiation of the clinical trails. To develop the schedule, the PM would need to take into account the amount of resources, the amount of team members performing the trials, the budget, and time designated for each task. A WBS will help create the Gantt chart after laying out all the tasks in order, showing dependencies of every task, determining task durations, and finding the critical path. There is also a trade off between having a device completed quickly, cheaply, or that is of good quality (can only pick two). Medical devices and clinical trials should always be of good quality to minimize risk, so the PM will need to see if the budget is large enough to speed up development without jeopardizing quality. The PM should discuss the schedule with all departments to make sure he/she is allocating a reasonable amount of time for each task.
The PM will also need to estimate the total cost of the project to determine the study budget, site budget, and center budget. The budgets will need to be negotiated with the doctors, and other participants like the Clinical Trials PM and department. Picking an appropriate budget during the planning phase is crucial, especially if a clinical trial contract at a fixed price is signed. It will also depend on how many stakeholders and sponsors there are, along with how much each is willing to invest.