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, and 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).

OSIRIS

Modifications: In the section "current status of study," Item 1, you will be asked to indicate the study status

Renewals: In item 2.0 of the Renewal Report Form, you will be asked to indicate the study status

 

Activities that may be done in each study status

* A waiver to document consent may have been approved in the protocol (section 4.6 of OSIRIS).  This means that you will obtain consent using a method other than written and signed (documented) consent.  Common examples include online consent for online surveys or verbal consent for research procedures.  Subjects enrolled using an alternative

** A waiver to obtain consent (frequently paired with a waiver of HIPAA Authorization) may have been approved in the protocol (section 4.7 of OSIRIS).  For example, this may apply to data collection when there is no subject interaction, such as when a protocol is limited to a medical record data abstraction.  Each person whose data is collected under this waiver is counted as an enrolled subject.

Other Considerations

Note that renewals of studies that have been deemed minimal risk can be expedited, even if they originally were reviewed by the full board.  Greater than minimal risk studies in long-term follow-up or data analysis only may also be expedited.

Once a protocol is closed, it cannot be re-opened.  Any new analysis or research procedures to be conducted after a protocol is closed require a new IRB approval for the new activities.  When all planned research procedures are completed, and materials are stored without / separately from direct identifiers, the protocol can be formally closed in OSIRIS even if data analysis is still ongoing.  All studies must be officially closed upon completion or termination of all research activities.  This includes when investigators leave the institution and no research will continue at this site. 

Once a protocol is closed, data must continue to be stored locally according to the University of Pittsburgh data retention policy as well as any other applicable data policies on data retention, storage, ownership, transfer, source documentation, etc. (e.g. FDA, sponsor, department, etc.).  Note that policies may differ based on subject age (e.g. child or adult) or other factors.

Additional Information

University of Pittsburgh’s Data Retention Policy: http://www.provost.pitt.edu/documents/rdm_guidelines.pdf