1. Responsibilities of Test Facility Management, Study Director, Principal Investigator and Study Personnel G. Jacobs Belgian GLP Monitorate
Zagreb, 17 December 2010
Juliette Wytsmanstraat 14 | 1050 Brussels | Belgium
T | | site web:

2. TEST FACILITY STRUCTURE
TEST FACILITY MANAGEMENT
Quality Assurance UNIT
ARCHIVIST(S)
STUDY DIRECTOR(S)
STUDY PERSONNEL

3. STRUCTURE IN A MULTISITE STUDY
TFM
LQA
ARCH SD
PI3
TSM QA
ARCH
PI1
PI2 3 3

4. Management
TF management means the person(s) who has (have) the authority and formal responsibility for the organisation and functioning of the TF according to the Principles of GLP
« Ensure, approve, establish  »
Can delegate parts to personnel of the Test Facility,
but not to the QA who must verify!

5. MANAGEMENT Who is “M”? Statement identifying the management
Description of company (scope)
Organisational charts
Responsibilities described
Evidence of involvement

6. MANAGEMENT ensure that a sufficient number of qualified personnel,
appropriate facilities ,
equipment
and materials
are available for the timely and proper conduct of the study;

7. MANAGEMENT Functions
ensure a Quality Assurance Programme with designated personnel
Assure that the quality assurance responsibility is being performed in accordance with the GLP principles
ensure designation of qualified and experienced Study Director.
Designation of Replacement of the Study Director according to established procedures. Replacement should be documented.
if needed, ensure designation of a Principal Investigator
ensure that an individual is identified as responsible for the management of the Archives;

8. MANAGEMENT Qualified personnel
ensure the maintenance of a record of the qualifications, training , experience and job description for each professional and technical individual;
ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;

9. MANAGEMENT & documentation
ensure availability of valid Standard Operating Procedures
approve Standard Operating Procedures!
ensure the maintenance of an historical file of all Standard Operating Procedures;
ensure the maintenance of a master schedule;
ensure documented approval of the study plan by the Study Director;
ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel;

10. MANAGEMENT & facility
ensure that Test Facility supplies meet requirements appropriate to their use in a study;critical requirements must be defined;
ensure that test and reference items are appropriately characterised; (sponsor or TF?)
establish procedures to ensure that computerized systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these Principles of Good Laboratory Practice.

11. MANAGEMENT & Multisite studies
Selection of test sites
ensure that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel;
Availability of equipment and expertise
Designation of Lead Quality Assurance
Information of test sites QA Units who is lead QA
Possibility of inspection

12. TEST SITE MANAGEMENT
Test site management has the same responsibilities
except for those relating to Study Directors
and communication
Provision of adequate site resources
Designation of Principle investigator
Designation of replacement Principal Investigator
Ensure the reporting to the Study Director

13. STUDY DIRECTOR Is the single point of study control
Has the responsibility for the overall conduct of the study
Has responsibility for its final report
However, the legal liability of the study director is established by national legislation and legal process, and not by the OECD principles of GLP

14. STUDY DIRECTOR Study plan
approve the study plan and any amendments to the study plan by dated signature, including delegated phases;
ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study;
ensure that the actual versions of the study plans, amendments and Standard Operating Procedures are available to study personnel;

15. STUDY DIRECTOR multisite study?
ensure that the study plan and the final report for a multi-site study identify and define the role of
any Principal Investigator(s)
and
any test facilities and test sites
involved in the conduct of the study

16. STUDY DIRECTOR
ensure the follow up of procedures specified in the study plan
assess and document the impact of any deviations from the study plan on the quality and integrity of the study
take appropriate corrective actions
Deviations
QAU audit report
acknowledge deviations from SOP during conduct of the study

17. STUDY DIRECTOR raw data
ensure that all raw data generated are fully documented and recorded;
ensure that computerized systems used in the study have been validated;
sign and date the final report
to indicate acceptance of responsibility for the validity of the data and
to indicate the extent to which the study complies with these Principles of Good Laboratory Practice;
ensure after completion of the study, the archiving of study plan, final report, raw data and supporting material

18. STUDY DIRECTOR multisite studies
Acceptance of test site selected
Control of the work at the test site
Maintain appropriate communication systems (telephone numbers, addresses, teleconferences, languages, servers)
The final report should incorporate any contribution of the Principal Investigators
Contact with personnel of the test sites if no Principal Investigator is designated, (farmers, subcontractors)

19. PRINCIPAL INVESTIGATOR
The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice: signature of the study plan and amendments
Acknowledgement of deviations by the Principal Investigator to the Study Director
Preparation of intermediate reports and delegated final report
Transmission of data and specimens

20. STUDY PERSONNEL contributing scientists, technicians
acknowledgement of the parts of the study to be performed
comply with the instructions given in the SOPs’. documentation and communication of any deviation
recording raw data promptly and accurately responsible for the quality of their data.

21. STUDY PERSONNEL exercise health precautions
to minimise risk to themselves
to ensure the integrity of the study
communicate any relevant known health or medical condition in order that they can be excluded from operations that may affect the study
Verify local laws about medical confidentiality (e.g. Colour blindness, deafness, diminished vision, infections…)

22. Summary Responsibilities
Management is responsible overall
Study Director is responsible for the study
Principal Investigator is responsible for their phase
Study personnel are responsible for their work

23. Thank you!
Zagreb, 17 December 2010

24. Addendum

25. Issues for Management Management not clearly defined
QA or SD assuming management role
QA not supported by management/insufficient authority
Lack of management involvement
Training records do not cover all activities
Lack of understanding of responsibilities

26. Issues for Study directors:
Study Directors not adequately trained, qualified and experienced
No documentary evidence to support their ability to act as Study Director
Inadequate resources
Study Director not discharging their responsibility
Sponsors/Regulatory affairs taking over responsibilities of Study Directors
Influence/pressure of Sponsors on discussion, causing bias of information in study report.

27. Issues for Study directors:
“Not my data”
“Deputy Study Director” - “Study Supervisor”
Study plan and amendments issued & approved by others
“test site” study plans
No audits performed by QA
QA unaware of critical phases
Study not listed on master schedule
QA not aware of change in study plan
Incomplete data records
Study Director not familiar with all data sets
Unvalidated computer systems
“non compliant” test sites used and not identified
Deviations not communicated
Deviations not acknowledged or recorded promptly

28. Issues for Study directors:
Impact of deviations not assessed
Reports not signed
Reports signed by someone other than the Study Director
Amendment signed by someone other than SD
No or misleading statement of compliance
No reference to Non-GLP work in SD statement
SOPs/ study plans not available
Amendments not sent to all holders
Test sites only getting an extract of study plan
Study personnel not familiar
Contracted work not included in study plan
Additional work requested