ICH Seeks to Flesh out Guidances on Data Quality, Medication Errors, Product Issues

The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a more detailed companion document that would include Q&A sections and more examples.

The organization’s Medical Dictionary for Regulatory Activities Management Board endorsed a move to build on guidance related to data quality in regulatory filings, including preapproval and post approval submissions.

The ICH noted that poor quality in the initial data collection, which could compromise the integrity of subsequent coding and analyses used to evaluate safety issues.

The examples the ICH intends to use for the expanded guidance documents will be approved by all ICH members and will not be based on agency-specific recommendations, such as the FDA’s guidance on data standards.

The companion documents would undergo frequent revisions to account for regulatory changes, the ICH said.

The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. Clinical Trial Compliance Guide is your searchable, one-stop source of all the FDA’s clinical trial-related guidances.