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 could compromise the integrity of subsequent coding and analyses used to evaluate safety issues.