Overall Recruitment Status definition

Overall Recruitment Status means the recruitment status for the clinical trial as a whole, based on the status of the individual sites. If at least one fa- cility in a multi-site clinical trial has an individual site status of ‘‘recruit- ing,’’ then the overall recruitment sta- tus for the trial must be ‘‘recruiting.’’

Examples of Overall Recruitment Status in a sentence

  • If a study requires human subjects review board approval, approval must be obtained before the study's Overall Recruitment Status is changed to Recruiting.

  • If your study requires approval, you may register your study on ClinicalTrials.gov prior to getting approval if the Overall Recruitment Status of the study is Not yet recruiting (see Overall Recruitment Status data element on ClinicalTrials.gov).

  • This data element plays a role in expanded access programs that is similar to the role of Overall Recruitment Status in applicable clinical trials, indicating whether a particular expanded access program is still open to participants.

  • If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting." Select one.

  • We believe such information is consistent with the statutory objective in section 402(j)(2)(A)(i) of the PHS Act to enable users ‘‘to track subsequent progress of clinical trials.’’ Similarly, we propose that if Overall Recruitment Status is updated to ‘‘terminated’’ or ‘‘active, not recruiting,’’ the responsible party also must update the Actual Enrollment data element.

  • In addition, we propose that if Overall Recruitment Status is updated to ‘‘suspended,’’ ‘‘terminated,’’ or ‘‘withdrawn,’’ the responsible party must at the same time provide information for the Why Study Stopped data element.

  • Overall Recruitment Status * FDAAA [Required when Study Type is "Interventional" or "Observational".]Definition: Overall accrual activity for the protocol.

  • We propose that the Overall Recruitment Status data element be updated not later than 30 days after a change in the overall recruitment status of the clinical trial.

  • Overall Recruitment Status *Definition: The recruitment status for the clinical study as a whole, based upon the status of the individual sites.

  • Overall Recruitment Status * Definition: The recruitment status for the clinical study as a whole, based upon the status of the individual sites.

Related to Overall Recruitment Status

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