1. Good Laboratory Practice
Study plan
Standard operating procedures
Conduct and Reporting
Dr. Wolf Burchard Bulling
Federal Institute for Risk Assessment Thielallee  D Berlin Tel  Fax 

2. Course of GLP Study (example)
Sponsor Request
Approval
TF Management
SD appointment Agreement
Archive
Draft Study Plan
Sponsor
Study Director
Preparation
Approval
QA Statement
SD signature
Study completion date
Final
report
Quality Assurance
GLP compliance
study conduct
Study
Plan
QA verification
SD Signature
Study initiation date
Signatures
Author, TFM
QA verification
SOPs

3. Study Plan
Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments (Definition OECD Principles)
The GLP regulations require that each study have an approved study plan and specify the information that must be in the study plan in relation to the study conducted
Study plans should conform to the GLP requirements
Study plan is a vital document for the reconstruction of study

4. Study Plan
sponsor agrees with study design
management involved regarding personnel, facility and material resources
study director responsible for scientific and technical conduct of the study
quality assurance for GLP compliance and planning of monitoring activities
serve as working tool for technical personnel who actually perform the activities
Study plans should be written to address the study objectives and the users needs

5. Study Plan
Study Plans should be
Not overcrowded

6. Study Plan
Study Plans should be
Easy to follow

7. Study Plan alterations
documented and
acknowledged by SD
unanticipated
anticipated
amendment
SP +
Amend- ment(s)
deviation
Raw
data

8. Study Plan alterations
Study plan amendment means an intended change to the study plan after the study initiation date.
foreseen circumstances
planned, permanent and deliberate systemic changes
usually standardised study plan amendment form
dated signature of study director
test facility management should also sign study plan amendment in case of change of study director or termination of study
maintained with study plan

9. Study Plan alterations
Study plan deviation means an unintended departure from the study plan after the study initiation date.
unforeseen circumstances
any departure (positive or negative) from approved procedures
study director must be informed in a timely manner
deviations should be described, explained, acknowledged and dated by the study director
maintained with raw data

10. Standard Operating Procedures (SOP)
to avoid unnecessary repetitions in study plans, the routine activities common to a number of studies can be described in SOPs
Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines

11. Standard Operating Procedures
General Format
Preparation
Authorization
Review / Revisions
Deviations
Coverage of all relevant activities
SOP List
Distribution and Collection
Availability
Archiving
SOP
about

12. Standard Operating Procedures
SOPs should be complete, concise and easy to follow
without dispensible information

13. Study plan and SOPs form a single package
Study Plan versus SOP
Study plan and SOPs form a single package
describing the scenario of the whole study.
SOPs
Study Plan
High
Variability
Low
Variability
Study Plan
SOPs
Studies with high variability
demand detailed study plans
and less SOPs
Standardised Studies
demand many, detailed SOPs
and shorter study plans

14. Conduct - Study Director - Role
Single point of study control with ultimate responsibility for the overall scientific conduct of the study
Coordinating input of management, scientific/technical staff and QAU
Request and coordinate resources provided by management (e.g. personnel, equipment and facilities) for the proper conduct of the study
Study plan design and approval
Overseeing data collection, analysis and reporting
Responsible for Final Report, scientific conclusions and compliance with GLP regulations

15. Conduct - Study Personnel - Role
Study personnel should:
have knowledge about GLP Principles applicable to their involvement in the study
exercise health precautions to minimise risk to themselves and to ensure integrity of the study
comply with the instructions given in study plan and appropriate Standard Operating Procedures and report deviations to the study director
record raw data promptly , accurately and in compliance with GLP, and are responsible for the quality of their data

16. Study Personnel – Raw Data
record of all study relevant activities
(record of data: directly, promptly, accurately, and legibly, no pencil, signed/initialled and dated)
corrections of raw data according to the GLP regulations
changes in the raw data should:
not obscure the previous entry
indicate the reason for change
signed/initialled and dated
Wrong
Correct

17. Final Report Final Report for each study
Corrections and additions to a final report should be in form of amendments (justification and signature of SD)
Reformating does not constitute a correction, addition or amendment
Original
Signed and dated by study director to indicate acceptance of responsibility for the validity of data and GLP compliance
Reports of PI or scientists involved signed and dated by them
QA Statement (specifies type, date and phase of inspections, reports to management), confirm that Final Report reflects the raw data

18. Final Report – Study Director Statement
Reference to GLP Principles
Exemptions clearly described
General GLP compliance evaluation
Not required by most countries
Dated signature of Study Director
Study Completion Date
End of the GLP Study

19. Thank you for your attention!
A N Y Q U E S T I O N S ?
Wolf Burchard Bulling