The ICH E6 Guideline, which is the backbone of how clinical research is conducted, is recently being revised. The new revision was released as an adaption to the increase in scale, complexity, and cost of clinical trial, which will be called E6(R2).

The updated guideline focus on updating and clarifying standards for electronic records and essential documents. The proposed changes affect the full clinical trial life cycle, from trial design, conduct, and oversight to data recording and regulatory reporting.

The revised E6 includes the following key changes:

– FDA define new definitions for monitoring plan, certified copy, validation of computerised systems and expansion on the definition of monitoring report. Source data should be “attributable, legible, contemporaneous, original, accurate, and complete” with any  changes to the original entry documented (audit trail).

– Several responsibilities have changed to ensure data management integrity

– A study-level quality management system  is implemented. A risk-based approach to quality management should be implemented and maintained during the entire life cycle of clinical trial. Development of a risk-based approach to monitoring should be implemented and the rationale for monitoring plan/ monitoring approach documented. The CAPA methodology should be used for any identified noncompliance.

– New SOPs and processes is placed for the validation and management of electronic system. According to this, electronic systems should be validated, backed up and safeguarded. The Trial Master Files should be searchable and retrievable.

Ultimately, the new document is designed to help clinical researchers protect human subjects, maintain data quality and integrity, and properly document trial results.

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