Budget Development Guidance

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 11/21/2019

File: Budget-Development-Guidance_2019.10.25.pdf

Clinical Research Protocol Checklist

A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research study. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol. The tool below includes both the ICH GCP recommendations for protocol content with some additional considerations provided by the UW-Madison Health Sciences IRB. Additional information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.

Updated 11/21/2019

File: Protocol-Checklist_10.25.2019.pdf