Chapter 1 talks about all
1, SOP concept
2, establish the SOP meaning
3, SOP, GCP and the correlation of the indol test project
4, SOP category
5, establish the SOP procedure
6, establish the principle that the SOP should follow
7, SOP the training demulcent therapy, reconciliation implement |
Chapter 2 The drug clinical trial research SOP
Section 1 regulation system SOP
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One, cardinal contents of the regulation system SOP
Two, the regulation system SOP plait writes the important point
Three, concrete contents |
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1. Clinical trial SOP document management system
2. The personnel's training system
3. The indol test uses the management system of drug
4. File room management system
5. The document return back to file with keep the system
6. Daily pursuit management system
7. Contract management system
8. Finance management system |
| Section 2 Mission |
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One, cardinal contents of the regulation system SOP
Two, the operation procedure SOP plait writes the important point
Three, concrete contents |
| Section 3 operates the procedure SOP
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One, cardinal contents of the operation procedure SOP
Two, the operation procedure SOP plait writes the important point
Three, concrete contents |
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1. Choose the SOP that the cardinal researcher, clinic studies the unit
2. The indol test uses the SOP of the drug( indol test drug and reference substance) preparation
3. The SOP of the clinical trial preparation
4. Train the SOP that the 监 checks the member
5. The SOP that clinical trial evolve
6. Convene to have another the SOP that the center clinical trial moderates the meeting
7. Establish the SOP of the conservancy that the blind demulcent therapy, reconciliation breaks the blind procedure, blind bottom
8. Know what happened the approval and know what happened the SOP of agree the book
9. The clinical trial researcher's SOP
10. The SOP that CRF fill in
11. AE and the SOP of the SAE report
12. The SOP that 监 check
13. Enlist the test-receiver's SOP
14. The SOP of the The data management
15. With bid for the , researcher message exchanges of SOP |
| Section 4 norm SOP |
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One, cardinal contents of the norm SOP
Two, the norm SOP plait writes the important point
Three, concrete contents |
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1. The clinical trial SOP design and the encode, code for norm
2. Draw up the SOP of researcher's manual
3. Draw up the SOP of the clinical trial project
4. The SOP of the CRF design
5. Know what happened the SOP of agree the book design
6. The sufferer's SOP of the record card design
7. The survey report of tells the SOP of design
8. The SOP of the database design
9. Draw up the SOP that the clinical trial statisticses the proposal
10.The SOP of the clinical trial summary |
Appendix:
1.The professional technical term, the language Chinese-English edition watch
Enclosure:
1.《 The drug clinical trial quantity management norm 》 ( this norm implements since September 1 in 2003)
2.《 The drug research supervision, surveillance management way 》 ( this way tries the line since January 1 in 2005) |
