DOCUMENTS |
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Finalized Protocol |
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Lab Manuals (Draft or Final) |
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Pharmacy manual (Draft or Final) |
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Imaging manual/requirements (Draft or Final) |
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Non-redacted FDA approval letter (for IDE, IND studies) |
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Finalized CRFs |
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eCRF completion guidelines |
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Central lab shipping requirements |
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Equipment List (Draft or Final) |
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Budget template (Draft or Final) |
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Operational manuals |
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NCT number |
COMMUNICATIONS |
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Site Point of Contact Email & Phone Number |
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Sponsor Point of Contact Email & Phone Number |
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CRO Point of Contact Email & Phone Number |
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Communication Plan |
TOOLS DISCLOSED |
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List of all vendors and systems being used |
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EDC |
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Regulatory |
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Source |
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Recruitment |
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Consent |
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Inventory Management |
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Other: __________ |
MISCELLANEOUS |
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Pilot/early phase data |
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Projected timelines for all parties |