FDA Releases Draft Addendum to ICH Good Clinical Practice Guideline

October 2, 2015

The FDA is seeking feedback on a draft addendum to the International Conference on Harmonisation’s good clinical practice guideline aimed at streamlining approaches to trial design, conduct, oversight, recording and reporting.

The draft, released last week, is the first update to ICH’s E6(R2) guideline in nearly a decade and  focuses heavily on tracking documents, preserving the accuracy of trial data and quality monitoring. It includes updated standards on electronic records and essential documents.

For example, the addendum asks that investigators verify that any outside companies or workers hired to assist in trials are qualified to do so, that they monitor their work and put policies in place to ensure the data produced are viable. The delegation and approval of tasks should be put in writing.

Source data should be “attributable, legible, contemporaneous, original, accurate, and complete,” with any changes to the original entry clearly marked. Particular attention should be paid to changes made on computerized systems, such as software upgrades and moving data, to ensure confidentiality and data integrity, the addendum says.

Key trial documents — whether stored online or elsewhere — should be searchable and retrievable, and electronic systems should be tested, backed up and safeguarded.

The ICH recommends a robust risk-based approach to quality management that provides justification for the chosen monitoring plan — on-site or centralized — and more tailored data tracking. The plan should also focus on practices that are not routine or well-known and root cause analyses of any noncompliance.

The 60-page addendum covers the full clinical trial spectrum from institutional review boards and trial design to monitoring responsibilities, data analysis and regulatory approval.

Regulators in the U.S., EU, Canada, Switzerland and Japan use E6(R2) to facilitate mutual acceptance of clinical data on new drugs and biologics.

Read the addendum at www.fdanews.com/09-29-15-GCP.pdf. — Victoria Pelham