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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 4: Database Lock (ALL Tasks)

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Tasks


  • Consult with the PO Site Coordinators and centralized data management staff (as applicable)to ensure that all remaining database discrepancies are resolved.
  • Ensure that biomarker or other endpoint data not entered into DCP OC-RDC have been e-loaded, posted to the CDT website, or otherwise included in the final SAS dataset for analysis.
  • Submit the completed Data Lock Checklist/Request to the DCP Monitoring Contractor via the DCP Help Desk. The database will be locked after confirmation that checklist items have been completed and the database is clean.

Timing Reminders


Data in the DCP OC-RDC database should be accurate, complete, clean, audited, and locked for analysis within three months of the last participant’s exit from the study.


Forms and Resources


DCP OC-RDC Job Aids: Responding to Manual Discrepancies: Step-By-Step and Reviewing Discrepancies: Step-By-Step
Tools that outline specific procedures within the DCP OC-RDC database. Available to any approved user of the DCP OC-RDC production database. To access, log in to the password-protected OC-RDC database, go to the ‘News’ section, and click on the ‘RDC Job Aids’ link.

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@westat.com or (888) 662-8354.




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

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