Prestudy validation documentation

In some instances, these recommended a priori acceptance criteria for model acceptance may be too restrictive and more lenient criteria may be appropriate with suitable justification and documentation. Model confirmation should precede the reporting of analytical results for validation samples. The standard curve for each in-study run (study sample analysis) should be monitored using the same criteria used during prestudy validation. 

The conference report from the Crystal City III Workshop outlines the documentation requirements in detail [10]. The degree of documentation should be sufficient to recreate the validation. Prior to initiating a prestudy validation, an appropriate standard operating procedure or a detailed validation plan should be written. This plan can be a stand-alone document or can be contained in a laboratory notebook or some comparable format. The documentation should clearly state the intended use of the method and a summary of the performance parameters to be validated. The plan should include a summary of the proposed experiments and the target acceptance criteria for each performance parameter evaluated. 

As described in this chapter, prestudy validation runs are accepted based on the standard-curve acceptance criteria. No run acceptance criteria are applicable for prestudy validation sample assessments i.e., no run can be rejected due to poor validation sample performance during accuracy and precision evaluation, and all data from the prestudy validation runs are reported without exceptions. In some cases, there may be assignable cause (e.g., technical issues) for removal of a validation sample data point before the calculation of the cumulative mean. Exclusion is applied at the end of the validation study period and must be documented as described in the documentation section. 

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