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.
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.
- 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||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||√||√||√||√|