Continuing Review of an Approved and Ongoing Protocol Irb

IRB Scheduled Continuing Review (SCR)

Per federal regulations outlined in 45 CFR 46.109(east), an canonical, federally-sponsored human being subjects written report must be reviewed, at least annually, by the IRB.  For this standing review, the IRB reviews the:

• Study protocol;
• Informed consent and other documentation or materials; and
• Whatsoever agin events (AEs) or other reportable events (ORIOs) that occurred during the current approval menstruum.

The IRB may recommend modifications or updates to a study upon continuing review.The continuing review process is not used to update an IRB application at the time of renewal.The study team would submit these changes for IRB review via the amendment procedure.

Nether the revised Common Rule, the post-obit no longer requires continuing review:

• Most of the new studies (i.e., those approved later January 21, 2019) that qualify for expedited review
• Studies approved prior to January 21, 2019 that have completed subject intervention/interaction, where the activeness is limited to either the terminal analysis of identifiable data/biospecimens or involves accessing follow-upwards clinical data from procedures that subjects would undergo equally part of clinical intendance.

​The IRB may require continung review for projects, but must document the reason to do then.  Mutual reasons include, but are not limited to:

• The projection sponsor requires continuing review
• The project involves additional regulatory oversight, such as conflict of interest (COI) management.
• The research will be conducted internationally or at non-UM sites
• An subpoena or incident study reveals new findings that crave additional oversight
• The investigator has had previous serious not-compliance or a pattern of non-serious not-compliance

Continuing review is required for research that is regulated past the Food & Drug Administration (FDA).

SCR Requirements

At U-Grand the standing review procedure is called a Scheduled Continuing Review (SCR).  The SCR is an online grade completed in U-1000'southward eResearch Regulatory Management (eRRM) system by a fellow member  of the study team to:

• Report the electric current condition of the research project to the IRB, inclduing the number of subjects enrolled; and
• Initiate the IRB review for the renewal of approval prior to the study's expiration date.

Report teams receive an automated email from eRRM at 90, lx, and 30 days prior to a report's expiration date as a reminder to submit an SCR, simply information technology is the Principal Investigator's responsibility to ensure that the SCR is submitted in a timely manner for IRB review.

Lapse in IRB Approving

A man subjects written report must retain active IRB approval until the study team has completed the work (e.k., all papers submitted and analyses completed) on the research, or until the data has been completely deidentified, including the destruction of any keys or codes linking the information to subject field identifiers. If the study requires continuing review and the approval menstruum expires (i.e., lapses), all research activity must terminate until IRB approval is re-established.  This means no new subjects may be enrolled in the study, no data may be collected, and information analysis is discontinued.  The only exception is when stopping the activity would jeopardize the welfare of the subject.  This exception is very rare for the type of research reviewed by the IRB-HSBS.

If the lapse is less than iii (3) months, the Prinicpal Investigator (PI) or study team may submit an SCR to initiate an IRB review for approval.  If greater than 3 months, the IRB may require a new application.  The IRB has the authority to require a full re-review of the written report in cases of lapsed approvals.

Terminating a Report at SCR

Principal Investigators have the option to cease the study at the fourth dimension of Scheduled Continuing Review (SCR) if the written report is complete (e.chiliad., activity limited to information analysis).  The SCR procedure volition directly the PI (or Faculty Advisor for studies where a student serves every bit the PI) to complete a Termination Written report in eRRM to close the project

"No Standing Review" Almanac Touchpoint

For studies that qualify for no continuing review ("No CR"), reporting the project status helps the IRB to monitor the study'southward progress.  To facilitate this, anAlmanac Touchpoint email is sent to the study team on the anniversary of the qualifying study's approval date.
This organization electronic mail acts equally an annual reminder for study teams to accept action, as needed, to update the condition of their written report through the amendment, incident reporting, or termination processes. The U-One thousand IRB Offices review the Almanac Status Report responses and IRB staff may contact investigators if boosted information or activity by the study squad is needed.

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Source: https://research-compliance.umich.edu/continuing-review-process

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