Trainings for Clinical Researchers
Who Must Complete CITI Human Subjects Protection Training?
All Key Study Personnel at UCSF or its affiliated institutions must complete human subjects protection training on the Collaborative Institutional Training Initiative (CITI) website. IRB approval of any individual application is contingent upon the fulfillment of this requirement.
UCSF Key Study Personnel (KSP) include the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research.
Key Personnel also include faculty mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
CITI human subjects protection training is only mandatory for KSP. However, we recommend that anyone involved with human subjects complete CITI training or similar human subjects protection training. IRB members, HRPP staff and Institutional Officials also must complete CITI training.
The UCSF CITI completion list and the SFVAMC list show which individuals have current training.
To complete CITI Human Subjects Protection Training:
Research Electronic Data Capture (REDCap) is a secure, HIPAA-compliant, web-based system for building and managing web-based research projects such as surveys and databases. The REDCap system provides functionality and features to enable researchers to rapidly develop databases and online surveys. These databases, data entry forms, and surveys are intuitive, easy to use tools for collecting data, including data validation. REDCap offers a Data Export Utility, which enables researchers to export their data in an automated manner into formats that are compatible with commonly used statistical analysis packages such as SAS, SPSS, Stata, and R.
Request a REDCap Account: HERE
REDCAP TRAINING CLASSES/WEBINARS
Research Electronic Data Capture (REDCap) Overview 101 Webinar or ILT Class. This course will provide an introduction to the features and functionality of REDCap. This course will cover how to create databases, surveys, and surveys with data entry forms in REDCap. This course will also provide an overview of the base features and functionality of REDCap, such as the Data Export Tool, Data Import Tool, User Rights Management, and Online Form Editor.
faculty type researchers. Nonetheless, some of these can apply to developing student researchers.
Please note: Most of these opportunities are geared for faculty type researchers. Nonetheless, some of these can apply to developing student researchers.
Upcoming IRB Classes: We offer regular training sessions on a variety of topics. Please register using the link provided for each class in the Events section. Contact us with questions.
UCSF Clinical Research Resource HUB's Suggested Training for Clinical Research: The HUB has published a useful checklist for both onboarding and ongoing training for Clinical Research Coordinators, PIs, and other research support staff at UCSF.
iRIS Training Videos: In January 2017, we uploaded thee new three iRIS training videos on the iRIS Help website (MyAccess login required). These videos show you how to locate your study documents, identify your IRB analyst and find your IRB approval letter. We plan on adding more videos in the future.
Resources for UCSF Clinical Researchers
iRIS ONLINE APPLICATION SYSTEM
Submitting in iRIS
Allow at least 4 weeks for the continuing review to be processed. Incomplete submissions will not be assigned for review.
SUBMITTING A NEW STUDY
IRB REVIEW PROCESS
DOES MY RESEARCH REQUIRE IRB REVIEW?
Research Involving Human Subjects
The IRB must review all research that involves human subjects performed by UCSF faculty, staff or students or researchers at UCSF-affiliated institutions, as described below.
Who Needs IRB Approval
UCSF faculty, staff, or students or researchers at UCSF-affiliated institutions conducting human subjects research require IRB approval before initiating the study. The site of the study and the source of funding — if there is funding — do not matter.
Principal Investigator (PI) and Co-PI Eligibility
The PI must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. The PI is ultimately responsible for all aspects of conducting the research study.
Students cannot be PIs
Students cannot serve as PIs. They are required to seek the sponsorship of a UCSF faculty member, who will serve as the PI on the study. These studies are often smaller scale unfunded studies.
Non-Human Subjects Research
Not Human Subjects Research Description
Procedures to Follow
Human Subjects Research Decision Tree
DESIGNING & DELIVERING YOUR RESEARCH POSTER
from the Office of Career and Professional Development