Purpose and Use of This Guideline Document

Repeat analysis Guideline

a. Purpose and use of this guideline document On occasion a clinical trial sample may give an anomalous result or alert value when the analytical assay has proceeded to completion without issue. The circumstances that allow repeat analysis must be transparent and clearly defined. It is never acceptable to selectively report data. This document provides guidelines as to how to develop a policy or procedure for the circumstances which allow repeat analysis.

b. Scope of this guideline document This guideline document does NOT cover analytical failure due to equipment failure or because a calibration curve or control sample(s) falls outside of the specified acceptance limits. Guidelines for this are available (see UOB-CLN-LAB-QCD-009 Analytical assay failure).

c. Developing a written policy and procedure It is recommended that a trial-specific policy is developed for the circumstances which allow repeat analysis, and this should be documented. The policy should define:  The rationale for performing repeat analysis.  The circumstances that allow repeat analysis e.g. what defines an ‘anomalous’ result or alert value, a consideration of sample availability and stability, assay reliability etc. It is also be advisable to produce a written procedure to describe how ‘anomalous’ results or alert values are identified, acted upon and reported.

d. Related documents UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory UoB-CLN-LAB-QCD-009 Analytical assay failure

UoB-CLN-LAB-QCD-018 Repeat analysis v1.0 (EAv1.0) Page 1 of 1