Important Reminders: Ensure Complete OCTA Submissions and Correct ICF Language Prior to IRB Approvals

April 14, 2025

The Office of Clinical Trial Activation wants to ensure your study activation process is as smooth and timely as possible. Recently, we’ve seen avoidable issues in submissions to OCTA and in Informed Consent Forms (ICFs) noted during our final compliance checks, which have delayed study activation.

Please take a moment to review the following reminders before submitting documents to OCTA or the IRB:

OCTA Submissions:

Reminder:

  • Submit ALL Required Documents for Submission to OCTA. OCTA cannot process submissions with missing documents.
  • Refer to Step 2 on our How to Activate a Study with Us page for the list of required documents for new study activations and amendments

Oversights & Impact:

Incomplete submissions increase administrative burden and delay progress in our activation pipeline. An incomplete submission may be cancelled and the study team asked to re-submit when they have all the documents. In some cases, we’ve seen Industry-sponsored studies submitted without Sponsor budget drafts, new industry sponsored study submissions require the protocol, consent form, sponsor budget draft, and draft contract.

 

ICF Language:

Reminder:

Oversights & Impact:

  • The Informed Consent Form language must be consistent with the final budget and coverage analysis. In some cases, we’ve seen where the documents are not aligned. If a discrepancy is noted during OCTA’s final compliance checks, it will cause a delay in activation.

ICF Section & Guidance:

Examples

Section 3.5: Are there benefits to taking part in this study?

  • Option 1: If there is a potential for benefit.
  • Option 2: If no direct benefit to the subject is anticipated.

When no direct benefit is stated in the ICF, the Coverage Analysis (CA) must reflect no therapeutic intent and all items/services must be covered by the study, and Section 15 must use Option 1.

Section 9: Will I be paid if I take part in this study?

Guidance: “Payment” refers to money that participants receive in return for their time and effort.

  • Option 1: If payment is provided.
  • Option 2: If there is no payment.

If the study will be providing payment or a stipend to participants as indicated in the study budget, this is to be included in the ICF using Option 1.  

 

Section 10: Will I be reimbursed for expenses if I take part this study?

Guidance: “Reimbursement” refers to money that participants are paid for specific costs they incur in order to participate in the study, e.g., transportation, meals, lodging, and parking.

  • Option 1: If there is reimbursement.
  • Option 2: If there may be expenses but they will not be reimbursed.
  • Option 3: If participants will not incur any expenses (e.g., travel, meals, lodging, parking, etc.).

 

If the study will be providing, for example, participant travel reimbursement and this is in the final budget or Clinical Trial Agreement, this is to be included in the ICF using Option 1.

 

Section 15: Are there any costs to me for taking part in this study?

  • Option 1: For studies in which the Sponsor will pay for all costs.
  • Option 2: For studies in which participants may be responsible for some costs.
  • Option 3: For studies with no costs.

For studies where the Coverage Analysis indicates all protocol-required items/services are paid for by the study, this is to be included in the ICF using Option 1. 

 

For observational/registry studies, Option 1 should be used for the ICF.

 

If you have any questions please check our website and the How to Activate a Study with Us page or ontact us at [email protected]. We appreciate your attention to these details which help us process and activate studies more efficiently.

Office of Clinical Trial Activation (OCTA)