Good laboratory practice study director

When the first draft of a protocol is typed, it is sent to the Quality Assurance Section to be audited. The protocol is checked for those details required by the Good Laboratory Practices guidelines. Comments about each protocol are sent to the study director. When the final version of the protocol is typed, it is again sent to Quality Assurance for review. The original copy of the signed and dated protocol is filed in the archive. 

Signature by the study director and dates indicating acceptance of responsibility for the validity of the data the extent of compliance with good laboratory practice... 

Good Laboratory Practice, GLP Consensus document, The Role and Responsibilities of the Study Director in GLP studies, 1999. 

In summary, four pillars support the structure of Good Laboratory Practice. All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data. Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end. 

In connection with the actual, experimental conduct of the study, it is the responsibility of the Study Director to ensure that all raw data generated are fully documented and recorded in compliance with the GLP Principles. For data recorded manually this entails ensuring that the data have been recorded promptly and accurately and in compliance with these Principles of Good Laboratory Practice if data are recorded electronically through the utilisation of a computerised system, the Study Director should ensure that (the) computerised systems used in the study have been validated , and are fit for use in the study. 

While it is the Study Director who is ultimately responsible for the quality of the study as a whole, he/she cannot be held responsible for the quality of each and every data point and each and every single record. This is clearly the domain of responsibility of the study personnel, who are are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the equality of their data . Certainly, these raw data will be scrutinised by the Study Director, who will use them for the preparation of the final study report certainly these raw data will be checked by Quality Assurance for their compliance with the provisions of the GLP Principles. However, data quality cannot be obtained retrospectively by control measures ( quality cannot be controlled into the data ), data have to be recorded in such a way that quality is an intrinsic characteristic of these records. Thus, this responsibility of study personnel for the quality of their data cannot be emphasised strongly enough. 

Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s) this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed. 

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