Mastering the CCI Redaction Balancing Act: A Structured 7-Step Workflow

Redacting CCI: A practical workflow to master the delicate dance between IP protection and transparency.

Building on yesterday's article, "Redacting CCI: Mastering the Balancing Act Between IP Protection and Transparency," below is a structured 7-step workflow for redacting competitive confidential information (CCI) from clinical trial documents. This practical workflow guides critical aspects of the CCI redaction process to help sponsors efficiently and effectively balance transparency and intellectual property protection.

Redaction Workflow for Clinical Trial Sponsors

1. Identify CCI

• Define CCI clearly and comprehensively.
• Align definitions with regulatory limits.
• Benchmark industry standards for identifying standard CCI.
• Establish policies, SOPs, and guidelines.
• Address global coordination of redaction.

2. Review and Confirm CCI

• Flagged content reviewed by legal/compliance teams.
• Confirm content qualifies as CCI per policy.
• Ensure accountability by logging all redactions (who, what, when)

3. Redact CCI

• Use automated redaction tools where possible.
• Block out text with black boxes or bars.
• Insert notes on the reason for the redactions.

4. Perform Quality Checks

• Check samples of redacted docs for proper redaction.
• Confirm that redaction notes are included.
• Ensure redactions are compatible with various global regulations.

5. Submit to CTIS

• Submit unredacted and redacted versions of the documents.
• Unredacted for regulators, redacted for the public.
• Maintain precise records of both versions for potential audits.

6. Implement Comprehensive Training

• Train all employees involved in the redaction process.
• Ensure consistent understanding of rules.

7. Periodic Process Review

• Conduct periodic reviews of the redaction process.
• Identify areas of improvement and implement necessary changes.

This structured, 7-step approach allows sponsors to redact CCI with greater clarity, consistency, and confidence across global teams and changing regulatory landscapes. Automation, training, and clear policies are crucial to success. Adapting processes proactively positions organizations to navigate evolving disclosure requirements.

Redacting CCI well is complex but critical. Please share your thoughts and insights below to advance industry collaboration on privacy and transparency. If you found value in this content, liking and sharing it will help other life sciences professionals navigate CCI redaction.

Invitation to Participate in the CCI and Anonymization Survey.

We invite you to contribute to an industry benchmark and current practices by participating in a survey about CCI and anonymization. Your input is valuable and will help future best practices. You can click here to participate.