Amending Your ICF

Updates in the safety profile of an investigative product is often accompanied by release of an updated investigators brochure (IBs), or by an action letter. The clinical development team can assist Principal Investigators on assessing safety updates to determine the best course of action necessary for the trial.

What to Expect

Updated IBs are reviewed thoroughly by members of the clinical development team and a summary of changes is prepared and provided to the Principal Investigator who reviews the summary and determines if and how the protocol or consent form template should be updated. IBs are complex and often lengthy documents, and it may take up to 3 weeks for this review to be completed and a summary of changes to be prepared.

Often IB updates are limited to changes in the toxicity and risk profile of the investigative product, requiring a change in the ICF only. These include:

• Identification of new risks
• Increase in risks identified
• Decrease in the expected benefit

If the protocol needs to be amended, the clinical development team works with the trial investigator to incorporate the necessary changes (refer to Writing Your Protocol Amendment).

The Process

The clinical development team uses the summary of changes to update relevant sections of the ICF template, as determined by the Principal Investigator, and make the updates accordingly. Once the amended ICF template is fully drafted, it is reviewed by the study team and then subsequently finalized. The finalized version is then provided to the study team for submission to the regulatory review bodies. ICF updates that are not accompanied by a protocol amendment do not require FDA review, unless LCCC is the manufacturer of the investigational agent. IRB approval typically takes 4-6 weeks.

Typically, protocol amendments require the informed consent form to be updated to reflect new or differing procedures and/or risks.

The Process

A member of the clinical development will assist in preparing the protocol amendment draft (refer to Writing Your Protocol Amendment). A second member of the team will perform quality assurance on the draft protocol and update the consent form template to reflect the protocol changes. The study team reviews the updated ICF, and revisions are made accordingly. For protocol amendments that review FDA review, LCCC typically includes a copy of the amended consent form in the FDA submission. The finalized copy of the ICF template is then released to the study team for submission to local regulatory bodies. IRB review and approval of a protocol amendment and ICF typically takes about 4 weeks.

Administrative letters serve as notifications for a clarification to ensure the correct intent of the protocol without diving into a full amendment.

The Process

When preparing an administrative letter, clinical development will also review the ICF to determine if any updates are required because of changes delineated in the letter. If it is determined that the ICF requires updating, clinical development prepares an updated ICF template. The study team reviews the updated ICF, and revisions are made accordingly. The finalized copy of the ICF template is then released to the study team for submission to local regulatory bodies.

Administrative changes to consent forms include making changes in the funding source, and typographical corrections.

The Process

Clinical development makes administrative updates to the ICF template. The study team reviews the updated ICF, and revisions are made accordingly. The finalized copy of the ICF template is then released to the study team for submission to local regulatory bodies.

Site-specific changes such as changes in the Principal Investigator, contact information, cost language or injury language are made by the site-specific regulatory team on the site-specific consent form.