Protect Confidential Information in Investigational Drug Submissions

CCI/CBI is information that isn’t available to the public yet. Examples include projects in progress, unpublished data, brainstorming notes, or plans for future studies. It could also include:

• detailed information on the quality and manufacturing processes
• details on the process validation or characterization techniques of active substances, or
• novel developments on products or intellectual property.

In short, it’s any information that if given to the wrong hands, could cause financial loss for the company.

The easiest approach/methodology for protecting sensitive company-specific information in regulatory submissions is through redaction. Read this blog to learn the differences between anonymization vs. redaction of clinical trial data.

Thus, along with the new guidance on what is personal data and commercially confidential information, the EMA and Health Canada’s guidelines target common items that do NOT constitute CCI/CBI. The most important indicator that information isn’t CCI/CBI is that it’s in the public domain. This may include the following locations and more:

Most information published in clinical research should, by definition, be of a clinical nature. However, there may also be additional administrative, quality-related, or non-clinical information.

These sections may look like CCI/CBI. Although some may be, the EMA has provided a list of items that are not CCI/CBI. This includes:

• Unit measurements, study IDs, names & addresses, vendors, sponsors, standard operating procedures (SOPs), study site IDs
• Structural formulas, lot #’s, excipients, high-level safety info, cell lines or strains, storage & shipping conditions, temp, humidity & other storage information
• Methods, drug concentrations, quantification limits, scientific advice received from regulators, information on technical methodology (ELISA, LC-MS, etc.)

Finally, every study contains insights into both internal procedures as well as clinically relevant information. These sections are usually located within the protocol or methods. They often contain information such as primary & secondary endpoints, statistical methods, inclusion & exclusion criteria, literature reviews, plasma drug concentrations, and PK/PD models.

These points can give insights into an organization’s methods. However, most regulators will deem this information relevant to understanding the research. Thus, they won’t allow sponsors to redact this information.

1. Is this information available in the public domain?
   • If you can find this information online via search engines, the company website, or publications, it’s not confidential.
2. Does this information hold economic value?
   • If disclosing this information doesn’t give a competitor some market advantage, it’s not CCI/CBI.
3. Is this information relevant for understanding the documents being published?
   • Some elements within a study may not be clinical, however they are still critical to understanding it. This type of information requires further investigation but will often fall outside the scope of CCI/CBI.

Do you need help preparing anonymized and redacted reports for EMA Policy 0070 or Health Canada PRCI submissions? Our transparency and disclosure experts can partner with you to develop the CCI/CBI identification criteria for a specific submission and manage the anonymization process, leaving a simplified review/approval step.