Pro7.1-19 SOP Checklist - Method Validation



|Author: Heidi Hanes |Document Number: | Pro71-20 |

| |Effective (or Post) Date: |17 June 2009 |

|Review History |Date of last review: |3 April 2020 |

| |Reviewed by: |Heidi Hanes |

|pSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or |

|specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol policies when considering the |

|application of this document. If you have any questions contact SMILE. |

Qualitative Method Validation SOP Checklist

|Qualitative Method Validation SOP Checklist |Document Number |040 |

| |Effective Date |17 Jun 2009 |

|Subject |Page |1 of 1 |

|CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS | | |

|Qualitative Validation Procedures | | |

| |Supercedes |New |

|Review History |Date of last review: |17 Jun 2009 |

| |Reviewed by: |Heidi Hanes |

| |Version # [0.0] |Revision Date |Description (notes) |

|Revision History | |[dd/mm/yy] | |

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CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS

Qualitative Validation Procedures

|Element |CONTENT-SPECIFIC REQUIRED ELEMENTS |

|Present | |

|CRITERIA |

| |Procedure identifies requirements for new qualitative methods and equipment to be validated and approved by the lab director |

| |before being place in service. |

|Comments: |

|PROCEDURE |

| |Procedure specifies minimum requirements for precision studies: |

|a.) |Note: Not applicable unless the qualitative values are derived from a quantitative result such as an optical density. |

| |Between day and/or within-in day studies - SMILE recommends performing both. |

|b.) |Sample requirements |

| |Matrix (controls, patient samples, etc) |

| |Levels (number and estimate - i.e., low/high, normal/abnormal) |

|c.) |Replicate runs per level - SMILE recommends 20 |

|d.) |Data evaluation - SMILE recommends using CV, where possible. |

|e.) |Acceptability criteria - SMILE recommends manufacturer’s limits or a percentage of the total allowable error. |

| | |

| |Procedure specifies minimum requirements for accuracy studies: |

|a.) |Acceptable reference or comparison methods - SMILE recommends previously validated and successful in-house methods be used for|

| |comparison testing. |

| |Sample Requirements |

|b.) |Matrix (controls, patient samples, etc.) |

| |Number of samples - SMILE recommends 10 samples for each expected result. |

| |Testing limitations (i.e., test old and new methods within 2 hours of each other) |

| |Data evaluation and acceptable criteria – Performance of qualitztive test is most commonly described in terms of sensitivity |

|c.) |and specificity. SMILE recommends using a decision/truth table. See SMILE Qualitative Validation Overview Guideline for an |

| |example. |

|d.) | |

| |Procedure specifies requirements for sensitivity and specificity verification on non-FDA approved methods. |

| |Procedure specifies minimum requirements for reference range studies: |

|a.) |Requires reference range verification or establishment, as applicable. |

|b.) |Manufacturer’s stated reference ranges may be used. |

| |Data evaluation and acceptable criteria – is the range of test values expected for a designated population where 95% of the |

|c.) |individuals are presumed to be healthy (or normal). |

|Comments: |

|DOCUMENTATION |

| |Procedure requires that all data and reports related to the validation be retained indefinitely and retrievable within 24 |

| |hours. SMILE recommends that data be retained in an organized manner using binders and dividers. |

|Comments: |

|References: |

|GCLP Workshop and Workbook18-20 May 2008, page 16 |

|E. Piwowar-Manning, et. al., HIV Prevention Trials Network Microbicide Trials Network Laboratory Manual, Version 1.0, Release Date: 15 |

|November 2006 |

|Clinical and Laboratory Standards Institute (CLSI). User Verification of Performance for Precision and Trueness: Approved Guideline-Second |

|Edition. CLSI document EP15-A2 (ISBN 1-56238-574-7). Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne, |

|Pennsylvania 19098-1898 USA, 2005. |

|NCCLS. (Currently CLSI) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition. NCCLS |

|document EP5-A2 (ISBN 1-56238-542-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. |

|Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples: approved Guidelines- Second |

|Edition. CLSI document EP9-A2 (ISBN 1-56238-472-4). Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne, |

|Pennsylvania 19098-1898 USA, 2005. |

|Clinical and Laboratory Standards Institute (CLSI).Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedure: Approved |

|Guideline – Third Edition. CLSI document EP10-A3 (ISBN 1-56238-622-0). ). Clinical and Laboratory Standards Institutes, 940 West Valley Road, |

|Suite 100, Wayne, Pennsylvania 19098-1898 USA, 2005. |

|Clinical and Laboratory Standards Institute (CLSI).Estimation of Total analytical Error for Clinical Laboratory Methods. Approved 2003. CLSI |

|document EP21-A (ISBN 1-56238-502-xX. Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne, Pennsylvania |

|19098-1898 USA, 2005. |

|Clinical and Laboratory Standards Institute (CLSI). Evaluation of the Linearity of Quantitative Measurement Approved Guideline-Second Edition,|

|CLSI document EP6-A (ISBN 1-56238-498-8) Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne, Pennsylvania |

|19098-1898 USA, 2005. |

|Clinical and Laboratory Standards Institute (CLSI).Defining, Establishing, and Verifying reference Intervals in the Clinical Laboratory |

|Proposed Guideline-Third Edition, March 2008. CLSI document C28-P3 (ISBN 1-56238-663-8). Clinical and Laboratory Standards Institutes, 940 |

|West Valley Road, Suite 100, Wayne, Pennsylvania 19098-1898 USA, 2005. |

|James O. Westgard, Online Validation Training, Westgard QC, Inc. , Module 10: Determining Imprecision. |

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