PROTOCOL CHANGE IN STATUS FORM INSTRUCTIONS AND INFORMATION

protocol change in status form instructions and information: * if you are requesting a change in the status of your study

PROTOCOL CHANGE IN STATUS FORM
INSTRUCTIONS AND INFORMATION:
*
If you are requesting a change in the status of your study, and
you are not submitting the change in status in conjunction with a
modification or a Continuation Status Report form, you are
required to complete this form. Email form to
[email protected]. Attach a completed IRB-HSR
Routing Form to the email. A receipt of acknowledgement for the
change in status will be returned to the contact person listed on
the routing form.
*
If you are PERMANENTLY closing the study, submit a Study Closure
Form. DO NOT submit this Change of Status Form. The Study Closure
form should be sent when all participants have completed the
required procedures and follow-up phases of the study and analysis
are completed to the point that participants' medical records will
no longer be needed.
*
DO NOT COMPLETE this form if you are relying on a Non UVA IRB; the
UVA IRB HSR only requires an email notification from the study
team when the study (overseen by a non UVA IRB) is PERMANENTLY
closed to enrollment.
IRB-HSR or UVA Study Tracking:  
PI Name:  
Protocol Title:  
At your site: Check one of the following:
Open to Enrollment.
*
If a Certificate of Confidentiality was required for this
protocol, the certificate must be current and not expired to
re-open this protocol to enrollment.
Closed to enrollment-subjects being treated. Total # of subjects
enrolled *:  
*
Check this option if you continue to perform interventions with
the subject (e.g. performing physical procedures such as x-ray,
ultrasound, use of an investigational drug/device/biologic).
*
If a Certificate of Confidentiality was required for this
protocol, the certificate must be current and not expired to
change the status to subjects being treated.
*
See information below regarding posting the consent form
Closed to enrollment-subjects in long term follow up**. Total # of
subjects enrolled*:  
**Long term follow up includes ONLY
*
research interactions that involve no more than minimal risk to
subject (e.g. quality of life surveys, survival status)
*
collection of follow-up data from procedures or interventions that
would be done as part of routine clinical care .
**Long term follow up does NOT include:
*
Any intervention that would be performed for research purposes
even if it is minimal risk (e.g. blood draw, MRI).
*
If a Certificate of Confidentiality was required for this
protocol, the certificate must be current and not expired to
change the status to subjects in follow up.
*
See information below regarding posting the consent form
Closed to enrollment-no subjects enrolled
*
Do not check this box if any subjects have signed a consent form.
*
See information below regarding posting the consent form
Performing Data Analysis. Total # of subjects enrolled*:  
*
See information below regarding posting the consent form
Temporarily Closed to Enrollment. Total # of subjects enrolled*:  
Indicate reason:
Temporarily closed by sponsor pending interim analysis
Temporarily closed by study team because  
Other:  
*
*If this study requires a signed consent, enter # of subjects who
have signed a consent form
*
*If this study is approved for waiver of consent, enter # of
subjects for which you have obtained data.
*
*If this study only collects specimens and has a waiver of
consent/ waiver of documentation of consent, enter the number of
specimens obtained.
Study Hold by PI
*
Examples of when a PI may place a study on hold:
*
PI going on extended absence and the study will not continue
during their absence under a new PI,
*
Lack of funding/ personnel for an extended period of time,
*
If this item is checked submit an attachment to this form which
includes the following information:
*
Notification that the study is being put on hold by the PI
*
A description of the research activities that will be
stopped
*
Proposed actions to be taken to protect current participants
*
Actions that will be taken prior to IRB approval of proposed
changes in order to eliminate apparent immediate risk of
harm
Posting of Consent Form
*
For each clinical trial* regulated under the 2018 Common Rule and
conducted or supported by a Federal department or agency, one IRB
approved informed consent form used to enroll subjects must be
posted to Clinicaltrials.gov or regulations.gov after the clinical
trial is closed to recruitment, and no later than 60 days after
the last study visit by any subject, as required by the protocol
45CFR46.116(h).
*Clinical trial means a research study in which one or more human
subjects are prospectively assigned to one or more interventions
(which may include placebo or other control) to evaluate the effects
of the interventions on biomedical or behavioral health-related
outcomes.
TIPS:
*
A consent must be posted for any study regulated by the 2018
Common Rule that is federally funded or FDA regulated.
*
Posting the consent form is usually done by the sponsor or overall
PI.
Comments:  
Do you confirm the PI is aware of this change? Yes No
Submitted by:   Date:  
IRB-HSR Staff reminder: If this study required full board review AND
is reopening to enrollment, verify that a full board continuation
review occurred within the past year. If not, then a full board
continuation review must take place before the study can be reopened.
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: May 28, 2019
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