Guide to DCP Study Close-Out: Milestones and Tasks

This guide assists Consortium Lead Organization (CLO) planning for DCP study close-out. Study close-out tasks are organized under milestones, which help mark progress toward completion of the close-out process. Once tasks associated with a milestone are underway, planning for the next milestone may begin.

Click on a milestone to view the associated close-out tasks.

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

Milestone 1: Study Accrual Nearing Completion

Tasks

  • Estimate when each enrolling site will complete accrual and each site’s last participant will go off study.
  • Ensure the CLO Monitors are scheduling each PO close-out visit to occur close to when the PO’s last participant completes the study.
  • Schedule a call with the DCP Monitoring Contractor to discuss preparations for database lock.
  • Discuss an expected date for submission of the draft manuscript with the Protocol PI and DCP Medical Monitor.

Timing Reminders

The draft manuscript is due to the DCP-PIO and DCP Medical Monitor within 120 calendar days when:

  1. All participants have met the primary study endpoint, and
  2. At least 80% of participants are off-study.

Forms & Resources

Milestone 2: Last Participant Completes Study

Tasks

  • Submit the Study Status Update Form to DCP-PIO when the last participant at the last site goes off study.
  • Determine the projected request date for database lock and final dataset delivery and notify the DCP Monitoring Contractor via the DCP Help Desk.Consult with the PO Site Coordinators and CLO data management staff to ensure that:
    • 1. Paper CRFs and data entry are completed for all study visits.
    • 2. QA reviews are completed per the approved Master DMP.
  • Ensure the CLO Monitor(s) complete(s) a close-out visit and, if necessary, a final annual/interim monitoring visit at each PO site per the DCP SOPs.

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 & Resources

Milestone 3: Research Lab Analyses

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 & 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, 61KB)
    A checklist for planning database lock. Once completed, it is submitted to request lock.
  • Checklist for Study Close-Out (DOC, 65KB)
    A planning tool for recording the projected and actual dates for close-out task completion.
Milestone 4: Database Lock

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 & Resources

  • DCP OC-RDC Job Aids: Responding to Manual Discrepancies: Step-By-Step andReviewing 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, 61KB)
    A checklist for planning database lock. Once completed, it is submitted to request lock.
  • Checklist for Study Close-Out (DOC, 65KB)
    A planning tool for recording the projected and actual dates for close-out task completion.
Milestone 5: Statistical Analysis, Study Completion, and Unblinding

Tasks

  • Confirm the Study Statistician's receipt of the final SAS dataset from the DCP Monitoring Contractor and the timeframe for completion of data analysis. Keep in mind the DCP-specified deadline for final study manuscript submission.
  • Submit the Study Status Update Form to DCP-Protocol Information Office to communicate the "completed" study status.

Tasks For Blinded Studies Only:
(after statistical analysis is complete)

  • Obtain approval for unblinding from the DCP Medical Monitor or their designee.
  • Notify the DCP Monitoring Contractor to initiate the unblinded data transfer process.
  • Communicate study agent assignments to PO sites using CLO standard institutional procedures to notify study participants. If the CLO was an enrolling site, follow institutional procedures for notifying participants.

Timing Reminders

The final manuscript is due to the DCP Medical Monitor, DCP COR, and the DCP-Protocol Information Office within 60 calendar days of study completion, or as specified in the CLO's contract.

Forms & Resources

  • Study Status Update Form (DOC, 30KB)
    A required form that lists study statuses from "Active" through "Completed."
  • Unblinded Data Procedure: Procedure for RDC Integration of Unblinded Data for DCP Chemoprevention Consortia Studies
    Available to approved users via the CDT website. To access, log in to the password-protected CDT website and click on the "User Tools and Documentation" link.
  • Checklist for Study Close-Out (DOC, 65KB)
    A planning tool for recording the projected and actual dates for close-out task completion.
Milestone 6: Final Manuscript Submission

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 COR, 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 & Resources


Questions? Contact the DCP Help Desk at dcphelpdesk@dcpais.com or (844) 901-4357.

Key to common acronyms: 

DCP Consortia Acronym List (DOC, 63 KB)

Media Folder: