Good Laboratory Practice A Study Directors Perspective and Experiences

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Good Laboratory PracticeA Study Directors
Perspective and Experiences

• Presented by Will Ruddock
• Director Toxicology
• ITR Laboratories Canada Inc.

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Introduction

• Definition of a Study Director (SD)
• Individual responsible for the overall conduct
  of the non-clinical health and environmental
  safety study
• The Study Director should have a very good
  understanding of the Good Laboratory Practice
  Regulations (GLP)
• As a Study Director working in a Contract
  Research Organization (CRO) there can be some
  challenges in running a GLP study

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Overview of Topics

• The Study Director and GLP Requirements
• The Sponsor
• Control of the study
• Assessing the impact of deviations on a study
• Contributing scientists
• Quality Assurance
• SD/Management Link
• Regulatory inspections
• Communication

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Study Director GLP Requirements

• Individual responsible for the overall conduct of
  a non-clinical toxicology study
• Represents the single point of study control and
  is responsible for
• Technical conduct
• Documentation
• Analysis
• Interpretation
• Reporting
• Archiving

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• Study Director GLP Requirements (continued)
• Prepares and signs protocol
• Indicates study initiation
• Ensures protocol adherence
• Modifications authorised and documented with
  reasons
• Ensures protocols are available to study
  personnel, QA staff and any Principal
  Investigators (PI).
• Ensures computerised systems are validated

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• Study Director GLP Requirements (continued)
• Ensures data are appropriately recorded
• Ensures deviations from SOPs are documented and
  authorised
• Ensures there is documented evidence of SD
  involvement throughout the study

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• Study Director GLP Requirements (continued)
• Reporting
• Prompt reporting of data
• Ensure data are fully reported
• Ensure all deviations and exclusions are reported
  appropriately
• Sign date the final report accepting
  responsibility for the validity of the data and
  GLP compliance
• Archive
• Ensure all raw data, documentation, protocols,
  specimens and final report are transferred to the
  Archive

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Study Director Perspectives

• There are many challenges encountered during the
  conduct of a study
• These involve dealing with
• individuals
• processes
• regulations

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The Sponsor

• Maintain good communication with the Sponsor
• The Sponsor often has a different perspective/
  understanding of GLP
• SD is the single point of control for the study
  but the Sponsor is paying

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The Sponsor (Continued)

• Test/control article characterization and
  stability information
• Getting the information up front is difficult
• Sponsor understanding why it is required
• If a test item characterization is questionable
  the study may have little value
• Understanding that the information you have is
  enough for the study
• Information not in a standard format and will
  differ from client to client
• Variety of compliance issues (reflected in the
  GLP statement)

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The Sponsor (Continued)

• Communicating study issues to the Sponsor
• Test article delivery
• Study delays
• Deviations on a study
• GLP exclusions
• Dealing with Sponsor comments
• Dealing with changes in reporting
• study results and conclusions

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Control of the study

• Study Director workload
• Usually heavy workload
• Management controls/feedback
• Priority given to in-life
• Good communication with staff at all levels
• Pre-study meetings need to be informative
• Providing them with relevant documentation
• Technical staff should feel that they can
  approach the Study Director
• Aware of what is going on
• Motivate staff
• Being proactive
• Documenting involvement

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Assessing the Impact of Deviations on a Study

• Being aware of deviations as they occur and
  addressing them at the time
• Leaving a problem to the end does not help
• Understanding the implication of the deviation
• Assessing the impact for the study
• Not just no impact
• Taking corrective action and involvement with
  operational staff to ensure they dont happen
  again
• Ensure that a deviation is not exaggerated

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Contributing Scientists

• In-house Scientists
• Acknowledge that you cant be an expert in
  everything
• Rely on the scientists specific expertise
• Ask questions
• Understand that the SD is still responsible for
  the contributing scientists report
• Collaborate with contributing scientist
• Use internal resources where appropriate to aid
  understanding
• Deal with interpretation issues

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Contributing Scientists

• Off-site (Multi-site Studies) with a Principal
  Investigator (PI)
• Do not know the scientist/Laboratory
• Sponsor can often contract the PI site
• It can be difficult to get them to speak to you
• Ensuring GLP requirements are appropriately
  addressed
• Good communication is key
• Careful that the communication is not just
  between the PI and the Sponsor
• SD needs to ensure that all documentation is
  passed to the PI
• Test site Quality Assurance
• Audits not specific so rely on the PI

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Quality Assurance

• SDs should see QA as necessary from the start
• Understanding the need to have QA is critical
• The SD needs to have a good working relationship
  with QA
• Must not use QA as a reason for the client
• GLP issue rather than a QA issue
• Must not take QA comments personally
• Take/ask for advice from QA
• What the regulatory authorities are focusing on
• Review of warning letters
• Dealing with inconsistencies
• SDs need to understand that there can be
  inconsistencies between auditors
• There can be new issues on old ways of doing
  things
• It does not mean they are wrong

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SD/Management Link

• The SD needs to ensure that sufficient resources
  are a available for a study
• Management need to put procedures in place to
  ensure quality study
• Management need to be kept up to date with study
  conduct and issues
• Concerns need to be heard and addressed

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Regulatory Inspections

• Be prepared to be part of regulatory authority
  visits
• If your study is selected bad Luck
• However, dont cry
• They are people too
• Show them respect and be professional
• Interviews
• Understand the study and issues
• Understand the SD role and responsibilities
• Understand the role of the Deputy
• Not recognized by GLP
• Need to be informed about the study
• Does not have overall responsibility for the
  study
• Used for short term absences only

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Communication

• This appears in the majority of sections
  discussed above
• It is one of the most important points
• SD must communicate with everyone
• Needs to ensure that there is understanding
• Good communicator
• Able to put others at their ease

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Communication

• Modes of communication
• Telephone (document appropriately)
• Mail (slow)
• E-mail (appropriate archiving of messages)
• Meetings (documented)

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QUESTIONS?