以下為EU GLP Working Group對OECD GLP問題的解答，我對部分內容進行了翻譯：
原文件名：QUESTIONSAND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND2004/10/EC ON GOOD LABORATORY PRACTICE (GLP)
多場所試驗中：
There is no obligation to transfer raw data to the study director under OECD rules if the principal investigator has provided the study director with a phase report. Raw data can be archived by the study director or the principal investigator.
PI可以只把原始數據複印件和/或階段報告給SD，原始數據的原件可以由SD或者PI在各自地點存檔。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP)
Q: The OECD consensus document 8, page 7, 4th paragraph specifies that “As the lead scientist, the Study Director must coordinate with other study scientists, and/or Principal Investigator(s) keeping informed of their findings during the study and receiving and evaluating their respective individual reports for inclusion in the final study report.” Does this phrase mean that the principal investigator is obliged to prepare an individual report of his delegated phase?
PI有義務準備一份所承擔階段的試驗報告？
A: The principal investigator should either produce a signed and dated report or transfer the raw data to the study director.
PI應該提供一根署名和日期的階段報告或者原始數據給SD。
The OECD consensus document 13, page 12 specifies that “The PI should provide the SD with contributions which enable the preparation of the final report. These contributions should include written assurance from the PI confirming the GLP compliance of the work for which he/she is responsible" … “Alternatively, raw data may be transferred from the Principal Investigator to the Study Director, who should ensure that the data are presented in the final report”. Taking this information into account, a single final report should be issued for each multi-site study.
PI應為SD準備最終報告提供幫助，包括PI的階段符合性聲明，另外，原始數據也轉移給SD（未說一定要是原件，則可以是複印件）。因此，每個多場所試驗應提供單獨的最終報告給SD。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP)
Q: Test Facility Management – should it be an individual or a team?
A: The GLP principles
allow having either an individual or a team. In the latter case, the management responsibilities (as defined in the OECD GLP Principles) allocated to each individual have to be clearly defined. Each individual may hold all or only some of these responsibilities depending on their role within the facility as long as it is clearly documented what their role and responsibility is, communication lines are clearly defined, conflict of interest is avoided and the requirements of the Principles are met.TFM可以是一個個體或者是一個團隊，若是後者，則應明確每個人的職責。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP)
什麼情況下Plan裡面的描述可以取代SOP？
Plan要很詳細，且不能和SOP的描述有模稜兩可的地方，且這個plan建議最好也讓TFM簽字。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP) 12）
Q: Is it a significant GLP deficiency when a study director prepares his (her) final report based in part on unsigned draft reports of contributing scientists?
A: The study director may prepare the final report based on unsigned draft reports, but before the final report is signed, all reports of the contributing scientists have to be signed by them in order to make sure that the content has not been changed.
SD可以基於未簽署的分報告來準備最終報告，但是在最終報告簽署前，所有的分報告應簽署掉，以保證內容不會再變動。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP) 15）
Q: Does an e-signature for GLP reports mean (1) a signature by the study director with his personal login + password in a secure IT environment or (2) the study director should fulfill the requirements of a qualified signature – qualified certificate by a qualified body?
A: The GLP Principles require that study plan, final report (SD statement) and QA statement are signed by dated signature. According to Directive 1999/93/EC on a Community framework for electronic signatures, only advanced electronic signatures which are based on a qualified certificate and which are created by a secure-signature-creation device satisfy the legal requirements of a signature in relation to data in electronic form in the same manner as a handwritten signature and are admissible as evidence in legal proceedings.
電子簽名要達到標準才能使用在GLP中。
——Ref. QUESTIONS AND ANSWERS CONCERNING THE IMPLEMENTATION OF DIRECTIVES 2004/9/EC AND 2004/10/EC ON GOOD LABORATORY PRACTICE (GLP) 21）
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