Evaluating a protocal budget

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1 September 2015

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“One of the overall primary challenges organizations conducting clinical research is lack of information about the overall clinical research enterprise” says CITATION KCl96 l 1033 (K Claxton, 1996)Matthew in a recent issue of medical research laws and policy report. Hence developing a quality budget proposal outline gives a better scrutiny and analysis of the funds flow.in a clinical trial conduct, in order to acquire better financial outcomes and pass out successful audits, there is needed to be more vigilant and careful in the financial management. “Establishing guidelines to streamline and aid the management of a clinical trial program will make managing less challenging” as CITATION kel p 1999 y l 1033 (Willenberg, p. 1999). This is being emphasized in order to meet the allocated budget for a given organization. Many hospitals and academic centers lack the trained personnel for them to review the study proposals and funds which consequently lead to incorrect billing for research. CITATION MBa04 l 1033 (M Barnes, 2004) “In order to evaluate the protocol requirement, you need to determine exactly what is going to be done as part of the protocol. Once that is completed, you should be able to determine what resources the site will need in order to implement the protocol”

Preparation for a budget clinical trial is done maybe when you want to obtain funds from a granter for your research or you have been paid to conduct a certain protocol by a pharmaceutical company.in such a case you develop a budget for your research, putting into considerations things like: laboratory tests, hospital admissions, patient visits, surgical procedures and fees for the above services.

These are considered as the resource requirements for you to develop a comprehensive budget. Below is a template example for a budget proposal outline I developed for a certain request for application. (RFA)

Below is our application budgetCITATION kel p 2001 y l 1033 (Willenberg, p. 2001)

RFA Title: Host- directed TB Therapy new approaches (UH2/UH3)

RFA Number: RFA-A1-14-058

Purpose of the RFA: The main purpose for filling this request of application is to curb the adverse effects of TB brought about by

Negligence and lack of follow up to these victims. This research is centered to direct TB therapies to the host individuals where each victim is screened and followed up for their healing process ensuring they take the right medication and avoid chances of infecting others.

Reason for selecting this RFA – I chose this particular RFA following the upcoming of new technologies and new machines especially the gene expert machine, which processes sputum, analysis it and determines the multidrug resistance individuals, enabling their follow up.

Budget (Time) Period: This clinical trial is programmed to take 2 years.

Budget Categories

Budget Category Description Cost $ Subtotal $


Principal investigator

Graduate research assistant (lab scientist)

Undergraduate research assistant (Nurse)

Data staff These relates to costs incurred by the staff involved in the research process. Different types of personnel are paid according to their experience and expertise. Rates of these personnel are charged either according to rate per study visit, hourly rate or full time. The budget also included costs for new recruitment of personnel and training. CITATION MBa04 l 1033 (M Barnes, 2004)78,200



8,000 122,200



Administrative work Costs incurred in offering services to the subject individual through evaluation, screening and costs for transport of specimen, batching and storage. 1100

270 1370



Clinical These are the cost needed to come up with facilities where the subject individuals are taken their specimen in this case sputum for analysis and how often they visit the clinics for checkup. These facilities are needed to offer these services. 30,000



Data capturing

-report forms



-printers Collected on case report forms and questionnaires thus need to be included in the budget. Costs also incurred in obtaining and developing these data. Computers, photocopiers and printers also included in the budget. Travel

Domestic trips

Domestic trips

Airfare This accounts for cost of all the trips made for training and meetings associated with the clinical trial, visiting other sites, scientific presentations and going to the research areas. 6400


4000 12600

Equipment and suppliers

-gene expert machine

Cost incurred for purchasing all the related equipment needed and paying the suppliers who bring the equipment and machines to do the case study (gene expert machine for sputum processing and analysis.) CITATION KCl96 l 1033 (K Claxton, 1996)20,000 20,000

Total Expenses 206,170

Indirect Costs The research incurred extra expenses on utilities (phone and internet), cleaning and rent at an overhead rate of 8%. CITATION Fra l 1033 (Stromberg)400 400



K Claxton, J. P. (1996). Health Economics.M Barnes, J. K. (2004). Journal of health law.Ognibene, G. a. (n.d.). Evaluating a protocal budget.Stromberg, F. (n.d.). Instruments for clinical health care research. 2004.

W.Staman, m. (n.d.). medical research laws and policy report.

Willenberg, k. M. (n.d.). managing clinical trials-frustrations.

Health economics”, (1996) – Wiley Online Library by K Claxton, J Posnnett.Look AHEAD research Group-controlled clinical trials”, (2003”- Elsevier.

Instruments for clinical health-care research” by M Frank-Stromberg, SJ Olsen (2004)

Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy” by SR Tunis, DB Stryer, CM Clancy-jama (2003)

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