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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 4: Database Lock

Close-out Tasks appearing under each milestone are generally initiated in the same timeframe. Click on the Timing Reminders and Forms & Resources tabs for more information.

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




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

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