Study Status

Overview

This document  provides guidelines about the status lifecycle of a project, and what a research team is permitted to undertake for each. The status can be changed at the time of renewal or modification of a protocol.  Note that exempt protocols and those given a “no human subjects” or “not research” determination do not require renewal and do not have a formal modification process.  Therefore this guidance is not applicable.

Description

Newly approved expedited or full board studies have a study status of “open to enrollment”.  As activities are completed, more restrictive study statuses can be chosen as appropriate at the time of renewal or modification, as described below.  Once a more restrictive status is selected, the study cannot revert to a less restrictive status so it is important to make this decision carefully.  For example, if any of the "Permanently closed to additional enrollment" options are selected, enrollment cannot be re-initiated unless a New Study is submitted.  Therefore, it is essential that enrollment not be closed prematurely.  Data and safety monitoring must continue throughout the study.

Study Status

  • remains ongoing (open to additional subject enrollment)
     
  • remains ongoing (permanently closed to additional enrollment but subjects continue to undergo research-related activities)
     
  • remains ongoing (permanently closed to additional enrollment and subjects have completed all required research activities but the research remains active for long-term follow-up of subjects).  Note: the IRB considers long-term follow-up to be limited to review of medical records (i.e., information collected for clinical purposes) and checking for survival status either through contact with the subject or by a review of the National Death Index).
     
  • remains ongoing (the ONLY research activity is data analysis. This does not apply to continued analysis of specimens).

Activities that may be done in each study status

Remains Ongoing Open to Additional Subject Enrollment Permanently closed to Additional Enrollment, but Subjects Continue to Undergo Research-related Activities Permanently Closed to Additional Enroolment and Subjects have Completed All Required Research Activities But the Research Remains Active for Long-Term Follow-up of Subjects The Only Research Activity is Data Analysis 
Enrollment of New Subjects (This includes enrollment of new subjects with verbal consent, written consent, or under a waiver of consent. )  √   X X
Research Procedures; Data Collection Procedures X X
Other Procedures which Generate New Data Such as Analysis of Specimens, or Receipt of Data by a Coordinating Center Protocol. Specimen Banking Protocols Should Not be in Long-term Follow-up Data Analysis if New Data May be Generated  X X
Review of Medical Records and/or Checking for Survival Status Either Through Contact With the Subject or by a Review of the National Death Index X
Analysis of Data that has been Collected (See Above Regarding Regeneration of New Data Through Additional Analysis of Specimens 
Sending Subject-level or Overal Study Results to Particiipants as Approved in the Protocol