Why Does This Matter?

To keep your study activation with the Office of Clinical Trial Activation (OCTA) smooth and efficient, we’re sharing key reminders about common, avoidable issues that have delayed recent activations and amendments. These include incomplete submission packets and Informed Consent Forms (ICFs) that don’t match the final budget or coverage analysis (CA). Such discrepancies can lead to unnecessary back-and-forth and place activations on hold until resolved.

What Should Be Included in Your OCTA Submission?

Before submitting study materials to OCTA, ensure all required documents are included. You can find the list for both new studies and amendments in Step 2 of the How to Activate a Study with Us page. Incomplete submissions increase administrative burden and delay activation. They may be canceled, and teams asked to resubmit once all documents are ready. We’ve recently seen industry-sponsored studies submitted without a sponsor budget draft. These submissions must include the protocol, consent form, sponsor budget draft, and draft contract.

Why Is ICF Language Consistency Important?

ICF language must align with the final budget and CA. When these documents are inconsistent, activation is delayed during OCTA’s final compliance checks. Ensure your ICF clearly reflects the same information found in your study documents and final CA, budget, and CTA to avoid this.

How Can You Ensure Your ICF Is Aligned?

To ensure ICF language is accurate and consistent, follow the HRPP’s guidance in the Companion Document on their website for studies reviewed by the UCSF IRB. For studies relying on external, private IRBs, see Other IRBs’ Consent Form Requirements.

• Use the correct ICF language options for benefits, payments, reimbursements, and sections based on your study’s CA, budget, and reviewing IRB. See possible situations, template option numbers to use (from HRPP’s Companion Document), and some clarifying notes below.