Orthopaedic Research Administration

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
Budget development involves three components:

1. Identifying the cost of all research items and services required for the study
2. Assigning financial responsibility for all items and services; and
3. Maintaining a process for recovering costs throughout the study.

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.

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 that you should consider before agreeing to participate in a trial.

Study Start-Up
Review the Study Start-Up Checklist and Process Diagram for Industry Clinical Trials

Need assistance or have clinical study management questions?  Please contact [email protected]

• Consent Development: With few exceptions, researchers must obtain and document prospective consent from the research subject before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand. For additional guidance on the informed consent process, please refer to UCSF policy. Find additional information on consent development on the relevant HUB web page.
• Clinical Trial Coverage Analysis, Billing & Budget: Leading institutions use a formal Coverage Analysis process to ensure compliant clinical research billing (CRB). A Coverage Analysis identifies all clinical items or services associated with a particular clinical trial, including identification of the financially accountable party, such as the trial sponsor, other funding source, patient, or a third party payor. The outcome of the Coverage Analysis process is sometimes called the “Billing Grid”. Find additional information on coverage analysis requirements, costs, and Oncore on the relevant HUB web page.
• Data Safety Monitoring: The NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.  Find additional information on data safety monitoring plans, protocol examples, NIH guidance, tools and templates on the relevant HUB web page.
• Data Management: The National Science Foundation (NSF) requires that all grant proposals be accompanied by a data management plan. Other federal funding agencies have similar requirements or will have soon. This guide will serve as a starting point to guide researchers through the data life cycle process with available tools either on campus or through the California Digital Library (CDL).  Find additional information on data management planning tools, NSF data mangement plan policy, FAQs, and data sharing on the relevant HUB web page.
• Feasibility Analysis and Guidance: The purpose of Feasibility Analysis is to evaluate studies involving human subjects for feasibility. If required by your Division, Department, or Organization, PIs, Sub-Investigators, or Study Coordinators may conduct a Feasibility Analysis using the  UCSF Clinical Trial Feasibility Checklist tool. For industry trials, you may complete the “Sponsor Expectations” section of the checklist and include any additional information as appropriate.  Feasibility analysis is not required prior to IRB submission.  Find additional information on scientific review, clinical trial protocol, and the feasibility checklist on the relevant HUB web page.
• Clinical Trial Protocol Development: Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.  Find additional information on sample protocol templates and resources on the relevant HUB web page.
• Recruiting Strategy: Successful study recruitment involves development and implementation of a well-coordinated plan that may require the efforts of the entire research team. Once in place, subject recruitment efforts must be frequently assessed, with new strategies implemented as necessary. The study team must only use recruitment strategies and advertisements that have been approved by the UCSF Committee on Human Research (CHR) for that specific study.  Find additional information on recruitment services, request consultation, guidelines and tools on the relevant HUB web page.
• Regulatory Binder: This binder is applicable for behaviorial, FDA, and non-FDA regulatory compliance. The UCSF Human Research Quality Improvement Unit (QIU)  is a Virtual Regulatory Binder that assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research.  Find additional information on how to schedule binder consultation on the relevant HUB web page.
• Safety Reporting: UCSF requires researchers to report any unanticipated problems involving risks to subjects or others in a timely manner. Unanticipated problems are problems that (1) are not expected given the nature of the research procedures and the subject population being studied; and (2) suggest that the research places subjects or others at a greater risk of harm or discomfort related to the research than was previously known or recognized.  Find additional information on determining whether an adverse event should be reported, guidance, and FDA regulations on the relevant HUB web page.
• Study Management: Clinical Trial study management tools, templates, and guidance for investigator-sponsored clinical trials refer to the relevant HUB web page.

• Definition of a Clinical Trial
• Clinical Laboratory Testing
• Training Oppurtunities
• Medical Center and Campus Safety Training
• Accessing Electronic Medical Data at UCSF
• iRIS/IRB Submissions
• Human Research Protection Training
• New Investigator Training
• How to Register a Study at UCSF
• Request Consultation on  reporting results on the ClinicalTrials.gov registry

Results Reporting Tools:

• Common Errors
• Pre-Submission Checklist
• Results Examples
• How to Submit Results
• Simple Results Forms SAS Macros
• Submitting Results Webinar