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The following rules, among others provided throughout this document, determine the criteria for completion of Complete trials: 

Trial AttributeCriteria
Brief TitleBrief Titles must be unique for each trial. The system searches all trials with processing status other than Rejected for matching Brief Titles during validation. Brief Titles are case-sensitive but the system does not consider extra spaces in its search for matches.
Trial Related DocumentsTrial must include a single active Protocol document and single active IRB Approval document.
Participating Sites
  • Each participating site must include at least one active investigator.
  • Each participating site must have a central or site contact.
Disease/Condition
  • Trial must include at least one disease/condition.
  • For studies that have any Trial Status other than Complete, every linked disease/condition term must be valid and current (not obsolete).
  • The system displays a warning reminding you to replace an obsolete term with its current equivalent term.
  • At least one disease/condition must be designated for inclusion in an XML document.
Interventions
  • Interventional trials must have at least one intervention.

  • For studies that have any Trial Status other than Complete, every linked intervention term must be valid and current (not obsolete).

  • The system displays a warning reminding you to replace an obsolete term with its current equivalent term.

Interventional Trial Design OutcomesInterventional trials must include at least one primary outcome measure.
Person/Organization

  • For studies that have a current Trial Status other than Complete, each person and organization abstracted must exist in the CTRP system.

  • The system displays a warning if a person or organization does not exist in the CTRP system.
Trial Status
  • Study Recruitment – Not Yet Recruiting:
    • Study Start Date can not be in the past.
    • Site must not be recruiting patients currently.
  • Review Board Approval correlation with the current Trial Status:
    • If the current Trial Status is In Review, the Board Approval Status must be Submitted, pending.
    • If the current Site Recruitment Status is Recruiting, the Board Approval Status can not be Submitted, Denied, or Not Required.
    • If the current Trial Status is Disapproved, the Board Approval Status must be Submitted, denied

If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.