Clinical Research Toolkit

Budget Development Guidance

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There are many costs to consider when developing a budget for clinical research. The goal of budget development is to fully reimburse costs associated with conducting a clinical research study. The information below includes some standard items to consider when developing a budget. This is a guidance document. The examples given do not apply to every clinical research project, nor is the list entirely comprehensive. There may be other costs to be considered on a study by study basis.

Updated 10/19/2022

File: Budget-Development-Guidance_10.19.22.pdf

Suggested Standard Operating Procedures (SOPs)

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In compliance with ICH Good Clinical Practice (GCP) and FDA expectations, research studies should be conducted uniformly, according to Standard Operating Procedures (SOPs). The list below is to be used as guidance; research teams are not required to have each of the SOPs suggested below, but rather should develop a customized set to meet their program specific needs. Research teams may need to develop additional SOPs related to specific research specialties or subject populations (e.g. Phase I dose escalation studies, enrollment of minors or vulnerable populations, evaluation of capacity to consent, significant risk procedures, etc.)