Step 2: Before You Submit

Required Training

Penn State requires initial and continuing (every 3 years) education in the protection of human research participants for individuals involved in the conduct or oversight of human participant research.  The training is offered through the Collaborative Institutional Training Initiative (CITI Program), a division of BRANY.

NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). GCP training (FDA or social/behavioral) is available through CITI

All CITI training requirements for relevant study personnel must be complete before approval can be granted for any CATS IRB submission involving the use of human subjects in research.

Instructions for CITI. Those with a Penn State account can access CITI via  

We have created a tool to help you decide which CITI training you need based on your role at Penn State and the work you are doing. Find the tool here:

Contact the Human Subjects Protection Office to learn about additional training requirements at the College of Medicine.

Additional Training

The University Park program also offer online and in-person training on human subjects research and the submission process. You also find a number of resources on our eduation and training homepage and in the Help Center in CATS IRB, discussed in Step 3.

Contact the Human Subjects Protection Office to learn about trainings provided at the Hershey location.

New to Penn State?

If you are new to Penn State, please note that you will not be able to access to CATS IRB until you have your Penn State access account. If you have a study that you are interested in transferring to Penn State, contact

Centralized Application Tracking System (CATS) IRB

CATS IRB is the web-based application system that Penn State researchers use to complete submissions for the use of human participants in research. CATS IRB also offers a wealth of resources, including an Investigator Manual and a Study Submission Guide. Once you have completed CITI training, you will have access to CATS IRB. To access CATS IRB without CITI training, personnel at all Penn State locations with the exception of College of Medicine should contact the University Park IRB program at and request access. For the College of Medicine, contact Human Subjects Protections Office at

Resources Available in CATS IRB

Before you submit materials to the IRB for review, take some time to review the Investigator Manual, an essential resource for principal investigators and other research personnel involved with IRB submissions and the conduct of human research. The Investigator Manual is designed to outline the responsibilities of investigators and includes important guidance on topics such as how to write a study protocol and document informed consent as well as crucial information regarding when IRB review and approval or determination is required and what information needs to be reported to the IRB post-approval. View the Investigator Manual.

The Study Submission Guide is also useful to review in advance and will help you navigate through CATS IRB. To access the Study Submission Guide, you’ll need to navigate to the Help Center in CATS IRB. The Help Center can be accessed via the Sidebar Menu on the left side of the screen in CATS IRB. Additional information on CATS IRB can be found in Step 3.

Policies and Guidelines

The Investigator Manual is the resource for investigators who need information regarding IRB policies and the responsibilities of investigators. Additional guidelines from the IRB program and Penn State policies can be viewed on the Policies and Guidelines page.

Single IRBs & Authorization Agreements

If you intend to submit a request for Penn State’s IRB to rely on an external IRB for review or for Penn State’s IRB to serve as the single IRB, please visit for information on how to complete the required Reliance Request Form.