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Good Laboratory Practices: Questions and Answers - Study Director
FIFRA Topics
- Good Laboratory Practices
- FIFRA Grants
- Inspections
- Worker Protection Safety
- Pesticide Producing Establishments
- Pesticide Imports and Exports
EPA has prepared responses to several questions in order to help clarify the Good Laboratory Practices Standards (GLPS) rule. The Questions and Answers are grouped into eleven different categories listed below. The following Questions and Answers serve as official written policy.
Applicability
Definitions
Study Director
- Many field studies involve more than one technical phase, each involving different personnel and different methodologies, often by different contractors. Concern has been raised over the difficulty for a single individual to physically oversee all phases and to be expert in all techniques involved. Within the same study, is it acceptable to assign a different study director to different phases?
- If there can only be one study director assigned to a study, is it acceptable to assign "field directors" and "analytical directors" to manage the work which involves different phases and/or locations?
Quality Assurance Units (QAU)
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
1. Many field studies involve more than one technical phase, each involving different personnel and different methodologies, often by different contractors. Concern has been raised over the difficulty for a single individual to physically oversee all phases and to be expert in all techniques involved. Within the same study, is it acceptable to assign a different study director to different phases?
No. Each study must have a single study director who represents the single source of study control. This is explicitly stated in the GLPS at 40 CFR 160.33. Single point of control is necessary to the integrity of the study and to avoid the potential for conflicting instructions and confusion in study implementation.
2. If there can only be one study director assigned to a study, is it acceptable to assign “field directors" and "analytical directors" to manage the work which involves different phases and/or locations?
The assignment of responsibility for the study to the study director need not interfere with ordinary delegation of authority necessary for the performance of study duties. Any authority accepted by persons other than the study director does not reduce the study director's overall responsibility for the study.