The Interpretation of Clinical Guidances & Regulations Initiative shares expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and Health Authority operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-life impact of ambiguous regulations/guidelines. While addressing these aims, the initiative will consider the highest priority to be continued enhancement of patient safety.
Quality Tolerance Limits: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Guidances: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Agency: ICH
Guidance Date: November 2016
Approach
- The topic team reviewed the 2016 Guidance and identified areas that may need clarification.
- The topic team then provided greater clarity on how to interpret and operationalize QTLs as per ICH E6 R2 through deliverables (see below).
Value
This topic’s objective was to improve the systematic quality of Clinical Research by facilitating the implementation of Quality Tolerance Limits (QTLs) in ways that advance compliance and efficiency but minimize confusion and duplication of effort.
Deliverables
| Asset Type | Title | Description |
|---|---|---|
 |
Quality Tolerance Limits Framework | A framework including a proposed definition of the term ‘QTL,’ process maps/steps, and examples of QTL parameters |
|
What You Need to Know About Quality Tolerance Limits Infographic | An infographic introducing how a QTL is defined, how they fit into the broader context of a Quality Management System, and when action may be taken because of a QTL |
|
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development | A peer-reviewed publication sharing the work done on the definition of the term ‘QTL’ and parameter guides |
|
Quality Tolerance Limits Plan Template | A template intended to aide sponsors in developing their own QTL monitoring plan |
|
Quality Tolerance Limits FAQs | A compilation of FAQs and responses |
|
Quality Tolerance Limits Text for the Common Protocol Template (CPT) and Clinical Study Report (CSR) | Model instructional text for inclusion in the TransCelerate Clinical Content & Reuse Initiative CPT and CSR Templates |
 |
This webinar reviews guidance and considerations for QTL implementation in Clinical Development through highlights from the TransCelerate Quality Tolerance Limits Framework, including but not limited to a proposed definition of the term “QTL,” process map/steps, and examples of QTL parameters. |
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