Bioequivalence Checklist

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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. | Randomization schedule| |
15. | Record of standardized meals| |
16. | Custodian reports| |
17. | Cannulation record| |
18. | 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...
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