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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 6: Final Manuscript Submission (ALL Tasks)

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Tasks


  • Ensure the Protocol PI and/or CLO PI submit(s) the final manuscript to the DCP-Protocol Information Office, DCP Medical Monitor, and DCP COR per the CLO contract.
  • Ensure that any remaining study data not included in the final SAS dataset for analysis are sent to DCP.

Timing Reminders


  • The final manuscript is due to the DCP Medical Monitor, DCP COTR, and the DCP-Protocol Information Office within 60 calendar days of study completion, or as specified in the CLO’s contract.
  • Any remaining data, including biomarker and other research laboratory reports, should be sent to DCP within 90 calendar days following completion of the study, or as specified in the CLO’s contract.

Forms and Resources


Checklist for Study Close-Out (doc - 67kb)
A planning tool for recording the projected and actual dates for close-out task completion.

Questions? Contact the DCP Help Desk at dcphelpdesk@westat.com or (888) 662-8354.



Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)

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