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Ap Psychology Case Study Essay

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Ap Psychology Case Study Essay
A | CLINICAL STUDIES | | Activity | Observation | 1. | Drug product data and information including receipt and correspondence for test and reference products | | 2. | Labelling of product and vials | | 3. | Record of transfer of samples to the deep freezer | | 4. | Curriculum vitae of various persons | | 5. | Monitor manual, Monitor report /checklist | | 6. | Initiation of clinical operations | | 7. | Protocol training attendance | | 8. | Delegation of duties | | 9. | Emergency medicines checklist | | 10. | Obtaining study specific ICF | | 11. | Master list of volunteers | | 12. | Subject check in record | | 13. | Drug dispensing forms | | 14. | …show more content…
| Check out record | | 19. | Deviation forms | | 20. | Drug accountability forms | | 21. | Screening consent | | 22. | Study specific ICF | | 23. | Proof of payment (compensation) | | 24. | Training records for selected individuals | | 25. | Dosing forms, labels and related documents | | 26. | Case report forms (CRFs) and laboratory reports for subjects 10, 15, 29 and 31 | | 27. | Training record for the monitor | | 28. | QA audit report for the clinical part of the study | | B | BIO-ANALYSIS | 1. | Method validation (precision, accuracy, ruggedness) | | 2. | Cross validation (anticoagulant effect CPDA and Heparin) | | 3. | Stability (including freeze thaw, long term) | | 4. | SOP for re-analysis | | 5. | Tabulated information for re-analysis | | 6. | Subject sample analysis - subject 9, 15, 19, 22 and 26 | | 7. | Form 11 for subject 9 (re-analysis) | | 8. | Source data and chromatograms including manual back calculation for S9 and S16 repeat analysis done | | 9. | Deep freezer log for placement and withdrawal of samples to verify number of samples for specific runs |
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