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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 3: Research Lab Analyses (ALL Tasks)

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Tasks


  • Confirm that applicable study research specimens from the PO sites have been shipped to the research lab.
  • Confirm a completion date for the study endpoint assays with the Research Lab Investigator.
  • Make arrangements with the DCP Monitoring Contractor for biomarker or other endpoint data not entered in the DCP OC-RDC database to be included in the final dataset for analysis.

Timing Reminders


There are no DCP-specified timeframes associated with this milestone.


Forms and Resources


DCP E-Loading Policy: Electronic Loading of Large Data Sets into DCP OC-RDC
Provides guidelines for datasets eligible for e-loading and includes the required form "Request for Electronic Data Transfer." Available to approved users via the CDT website. To access, log in to the password-protected website and click on the "User Tools and Documentation" link.

DCP OC-RDC CLO Data Lock Checklist/Request (doc - 65kb)
A checklist for planning database lock. Once completed, it is submitted to request lock.

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@dcpais.com or (844) 901-4357.



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

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