【文章內(nèi)容簡(jiǎn)介】 ogy ? Necropsy ? Reports 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Test Article ? Calculations How much will you need? ? When is it available? ? Final doses? ? Analytical Confirmation ? Storage/handling conditions ? Certificate of Analysis (COA), MSDS, purity, stability ? Is there a dose formulation? 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Protocol – Review amp。 Approval ? Management ? SD ? Sponsor (if done by CRO) ? Scientific contributors and laboratory staff ? Report preparation staff ? QAU ? IACUC 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Ovetsight of Study Conduct ? Observe animals and procedures ? Review data ? Communicate with scientific contributors and technical staff ? QA audits – internal and external ? Interactions with contributors/ PIs – Submission of samples – Receipt/review of report ? Respond to unexpected events 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Oversight of Study Conduct ? Protocol amendments a planned change ? Protocol deviations – not planned。 impact on study must be determined ? SOP deviations 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Example of Documentation ? Protocol/protocol amendment ? Protocol/SOP deviations ? Animal order ? Test article receipt/information ? Test article preparation procedure ? Dose accountability (out of range?) ? Study file notes ? Veterinary requests/approval of treatment ? Environmental deviations (. light/dark cycle and humidity) observations of animals/procedures ? Data review ? Correspondence , fax, letter, telephone calls ? Reports 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Report Preparation 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) Archiving ? Protocol/amendments ? Raw data ? Documentation ? Specimens ? Final report 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) SD Responsibilities for a Final Report ? Data interpretation ? Preliminary draft – audited? unaudited? ? Integration of toxicology, pathology, TK and other supportive data ? Contributing Scientist/PI reports ? Stopped/suspended programs ? GLP pliance ? Deviations and impact on data 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) STUDY DIRECTOR: (cont’d) assures that: ? protocol, including any changes, is approved as specified in GLPs, and is followed ? all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified ? unforeseen circumstances, that may affect the quality and integrity of the study, are noted when they occur, and that corrective action is taken and documented 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): Oversees GLP Compliance in laboratory ? responsible for monitoring each study for GLP pliance ? anizationally, QAU reports to test facility management ? independent of the personnel engaged in the direction and conduct of individual studies ? assures that facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLPs 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) Oversees GLP pliance in laboratory ? keeps uptodate records of all studies scheduled/performed with master schedule at lab ? maintains copies of all study protocols 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? Inspects studies – at intervals adequate to assure the integrity of the study – maintains written and properly signed records at each inspection identifying ? date of inspection ? the study inspected ? phase or segment of study inspected ? person performing inspection 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? maintains written and properly signed records at each inspection identifying ? findings and problems observed during inspection ? scheduled date for reinspection, if applicable ? problems must immediately be brought to attention of study director and management 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? submits periodic status reports on each study to management and study director – notes problems – notes corrective actions taken ? determines that no deviation from approved protocols or standards operating procedures were made without proper authorization and documentation 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) QUALITY ASSURANCE UNIT (QAU): (cont’d) ? Reviews final study report to assure that: – report accurately describes methods and standard operating procedures – reported results accurately reflect the study’s raw data ? Prepares and signs statements to be included with the final report specifying details on inspections 現(xiàn)場(chǎng)核查要點(diǎn)：職責(zé) Facility Operations ? Standard operating procedures (SOP) ? Complete and prehensive ? Up to date ? Sound science and practical ? Reagents and solutions ? Identity, titer/concentration, storage requirements, and expiration date ? Animal care and IACUC Major issues of data audit What do we look for while auditing a GLP lab Study Director Facility Management Quality Assurance Chemistry Pathology (Clinical and anatomical) Technical Staff Report writing Sponsor Accounting Subcontractors 非臨床實(shí)驗(yàn)室常見(jiàn)錯(cuò)誤 Study director ? Failure to follow protocol Most mon because everything is driven by protocol. Examples: – TA Stability determination – Environmental conditions – Exposure to test article (dosing) 非臨床實(shí)驗(yàn)室常見(jiàn)錯(cuò)誤 Study director (cont’d) ? Final Report Commonly see failures to address issues that occurred during study that could affect outes 非臨床實(shí)驗(yàn)室常見(jiàn)錯(cuò)誤 Study director (cont’d) ? Failure to record all data and verify Formulation Dosing 非臨床實(shí)驗(yàn)室常見(jiàn)錯(cuò)誤 Study director (cont’d) ? Documentation issues ? Best way, protocol amendment. Must be done before a