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Clinical Research

The Department of Surgery is committed to finding new ways to prevent and treat disease in people through clinical trials research to fulfill UCSF’s mission as a leading health sciences university. Clinical trials are done through a study and below is the process of how to design and conduct a study from beginning to end and valuable resources to help its success. 

View Dept. of Surgery Clinical Trials

Study Overview

For an overview and requirements of how to start a clinical trial, see the Study Start Up Checklist and Process Diagram. Other useful resources can be found at UCSF HUB's Study startup and Clinical Study Management.

Components to Consider Before Starting a Clinical Trial

Protocol Template

A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a trial. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol. See the Sample Protocol Template when developing your protocol. Many of the NIH institutes have their own protocol templates. Examples are available at the NIAID website.

Budget Development

Every investigator should have a clear financial management plan to adequately support their research endeavors. The plan should include a defined department process and a responsibility log which outlines the team members accountable for the process. Please review Clinical Trial Budgeting & Billing before starting your study.

Coverage Analysis

Coverage analysis is the independent review of a human research study to determine which patient care costs are billable to insurance and which are not. Learn more about coverage analysis here. Awards involving human subjects’ research require coverage analysis and budgets review. To initiate coverage analysis, email clinical trails.

Feasibility Checklist

When approached with an invitation to participate in a clinical trial, the investigator usually receives a copy of the protocol or a protocol synopsis. It is very important to carefully review and evaluate the protocol and determine if appropriate patient population and resources are available for successfully completing the trial. The Sample Feasibility Checklist gives you a list of questions to consider before agreeing to participate in a trial.

For additional assistance with study management tools, please email the HUB.

Staff Onboarding Trainings 

Please review the Suggested Training for Clinical Research checklist created for Clinical Research Coordinators (CRCs), PIs and other clinical research support staff at UCSF, both for onboarding and ongoing training.

 

Clinical Research Resource HUB

The HUB is a virtual Clinical Research Resource that provides a single portal to a wealth of resources, expertise, and best practices for investigators and research staff to facilitate efficient, compliant and ethical study conduct and management.
The Human Research Protection Program (HRPP)

The Human Research Protection Program (HRPP) reviews and monitors research involving human subjects at UCSF and several affiliate institutions to ensure the ethical and equitable treatment of the research subjects.

 

Centralized Clinical Trials Resources 

Includes various resources to help start and manage clinical trials for Principal Investigators and staff.

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