Human Research Protections Program
IRB Continuing Protocol Application (CPA)


Welcome to the Continuing Protocol Application (CPA) Module!

Please do not use the "Back" button of your Browser to navigate through the module. Use the "Save" buttons to navigate within the application.


Information:

Drafts will be deleted after 120 days if they are not submitted. Deleted drafts cannot be recovered.

Expedited* and Exempt IRB protocols must submit a short version of the CPA every three (3) years. Investigators should plan ahead and submit 60 days prior to the 3rd year anniversary of the initial study approval.

*Please note that Expedited IRB protocols that meet the following criteria must submit the long version of the CPA annually (not more than 365 days):

  • Subject to federal oversight (e.g., NIH, DOD, DOE funded)
  • Subject to Food and Drug Administration (FDA) oversight
  • Funded/supported by the California Institute for Regenerative Medicine (CIRM)
  • Involves single IRB review/Reliance
  • Subject to UCI Conflict of Interest Oversight Committee (COIOC) review
  • Involves interventions with prisoners/parolees

Full Committee IRB protocols must submit a CPA at least annually (not more than 365 days). Investigators should plan ahead to meet required continuing review dates. For full committee review protocols, please submit 90 days prior to the expiration date to guard against a lapse in IRB approval.

Seven-Year De Novo Review for Full Committee IRB Protocols: Any Full Committee protocol in its 6th year of IRB approval requires Seven-Year De Novo Review where in addition to completing this CPA application, submission of updated protocol documentation is needed. Instructions for submitting for De Novo Review are available online.

What happens if there is a lapse in IRB approval?

If the IRB has not approved a research study prior to the expiration date, all research activities must stop+. This includes:

  • Recruitment and informed consent procedures
  • Collection of information/biospecimens from or about living individuals
  • All research-related interventions or interactions with currently enrolled subjects
  • Analyses involving identifiable human subjects information/biospecimens

+Exception: Research-related interventions or interactions with enrolled subjects may continue if the IRB determines that stopping the research would jeopardize the rights or welfare of current subjects. A request for such an exception must be submitted in the writing to the IRB by the Lead Researcher. The IRB will decide which subjects should continue receiving the intervention during the lapse in approval.


Instructions:
  1. To create or submit a Continuing Protocol Application (CPA), users must login with their UCINetID and password.
  2. Any member of the study team may create and save a CPA. Only The LEAD RESEARCHER or FACULTY SPONSOR can electronically submit the application to the IRB.
  3. To print the .PDF version of the submitted CPA, click here

Create, review and/or submit an electronic Continuing Protocol Application



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