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T-50
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T-40
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T-30
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T-20
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T-10
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In-Life Phase
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T+10
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T+20
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T+30
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T+40
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T+50
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T+60
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T+70
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a) Initial planning T-50 |
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b) Confidentiality agreement |
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c) Request for draft quote T-50 |
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d) Approval of draft quote T-45 |
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e) Initial study plan T-30 |
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1) Analysis of dose solutions (method and schedule) |
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4) Test and control article handling and storage |
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6) Dosing: route of administration, regimen, duration |
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9) Necropsy/gross pathology |
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10) Clinical chemistry parameters |
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11) Histopathology parameters |
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12) Analysis of data (statistics) |
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f) Draft study protocol T-28 |
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g) Set pre-study meeting date (CRO staff) T-28 |
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h) Pre-study Sponsor—CRO meeting (preferably in person, or by video or teleconference) T-14 |
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a) Sponsor company: technical contact, admin contact, other |
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b) CRO: technical management, study director, QA, admin |
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2) Review and clarify: protocol, study background, deadlines |
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i) Protocol approval T-10 |
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j) Sponsor transfers test article to CRO T-3 |
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k) Sponsor and QA review draft report T+29 to T+50 |
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l) Sponsor receives final report T+60 |
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m) Team review/evaluation with CRO T+70 |
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