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. 2024 May 31;40:101291. doi: 10.1016/j.conctc.2024.101291

Table 2.

List of required materials to initiate Protocol-specific Site Feasibility.

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