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Show PMX-106l Page 11 of 13 expected to significantly affect the test results. if any, will be reported. 5.4 A detailed description of each protocol deviation. Quality Assurance Inspections/Audits The Quality Assurance Unit will conduct one or more inspections to determine whether the tests are being conducted according to the protocol and applicable SOPs In addition, the report and accompanying data package will be audited by the QA Unit for compliance with the protocol and QAPP. 6. 6.1 REPORTING Report Format The test results will be presented in a report summarizing the data. The information reported will include, but will not be limited to, information shown in the report outline presented in Table 2. 6.2 Data Retention All raw data, copy generated in the toxicity studies will be provided to the Study Sponsor. All raw data, protocols, and final reports generated will be retained in Parametrix' s archives. The archives will be secured for entry by authorized personnel only and will be stored or an exact in an orderly manner to allow for rapid retrieval. All information concerning this study will be stored in Parametrix' archives for a maximum of two years, after which it will be transferred to the Study Sponsor. |
