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

Suggested Standard Operating Procedures (SOPs)

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.)

ICTR Clinical Research Manual: A Guide to Conducting Clinical Research within UW-Madison

The purpose of this manual is to build on human subjects protection principles and Good Clinical Practice (GCP) standards, while describing how to apply these regulations and standards to the day-to-day conduct of clinical research studies at UW-Madison.

This manual is intended to accompany and complement the UW-Madison online course, Basics of Conducting Clinical Research at UW-Madison, and to serve as a resource and reference for our research staff. This manual has been written both as an introduction to those who are new to clinical research at UW-Madison, and as a refresher for more experienced clinical research staff.

The content in this manual is geared toward research staff who conduct clinical research studies within the UW Health environment, however, the majority of content will be applicable to clinical research involving human subjects in all types of settings.

File: ClinicalResearchManual_2018.05.31.pdf