STUDY CHANGE-IN-STATUS
Guidelines for Completing the Form
This brief guide will assist you to complete the Study Change-in-Status Form.
The information provided on this form is used by the Ethics Services, Research Services, the
Research Ethics Board, and individual Departments involved in the study to monitor their
involvement in your study, and to monitor any changes in the safety of the study for
participants.
A Study Change-in-Status form must be completed and forwarded to Ethics Services within
10 working days of the change. Changes that may occur are: closure to recruitment, closure
of the study, discontinuation of the study, suspension of recruitment, re-initiation of recruitment,
suspension of the study and re-initiation of the study.
It is the responsibility of the Local Principal Investigator to ensure that the Study Change in
Status Form is submitted and that the information contained in the Study Change in Status
Form is accurate and complete. At the time of submission of the original Change in Status
Form to Ethics Services, a copy of the form must be sent (by the Principal Investigator)
to Research Services and any departments involved in the study. Nursing units
involved in the study should be advised of the change in status of the study, however
they probably do not need to have a copy of the form. It is necessary to advise all parties
involved in the study to ensure that they are up to date on the status of the study. The
information regarding the change impacts each area differently depending on the working
relationship that has been established with the department, nursing unit or office. (For
departments providing a “service”, it impacts the workload requirements for services provided,
for nursing units it may impact recruitment or participant care, and for Research Services it
impacts billing/invoicing).
The Study Change in Status Form and any accompanying documents will be reviewed by a
Primary Reviewer, and the form signed to document the primary review.
The Primary Reviewer may contact the Principal Investigator or their designate if clarification is
required or if areas of the form are incomplete. The Primary Reviewer may enter data where it
is missing or make corrections to data (on the Study Change in Status Form) based on
information in the REB file or the research database. These entries will conform to the
standard GCP requirements (GCP 4.9.3). After the primary review is complete, the re-approval
submission will proceed to the REB meeting.
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Please submit the following:
1 original completed Study Change in Status Form (to Ethics Services)
1 copy completed Study Change in Status Form (to Research Services, and any department
involved in the study). Please advise any nursing unit involved in the study (they may not need
a copy of the form).
Please keep documents that will require an REB signature separate from other documents that
you may have enclosed with your submission. (Do NOT staple documents requiring an REB
signature to the other enclosed documents).
INSTRUCTIONS FOR COMPLETING THE FORM
Please note that unless an item is ‘not applicable’ for your study (which must be clearly
indicated) ALL sections must be completed.
When completing the form, please use the “tab” key when moving between data fields. If
this is not done the formatting of the document will be altered and some information will
become lost/hidden in the form. If you require assistance or have any questions, please
contact Ethics Services.
1. Research Study / Protocol Information :
Study / Protocol Title (Full Title)
Enter the full title. Regulatory and administrative agencies and GCP require that the full title (as
it appears on the sponsor’s protocol or your study proposal) be used to reference each study.
Protocol Number
Enter the Protocol Number (if applicable). Original research (investigator initiated) and student
research may not have a study or protocol number, in which case indicate N/A (not applicable).
Current REB Approved Protocol Version/Date
Enter the Version Number (if applicable) and the Version Date of the protocol that is currently
approved by the REB. All protocols should be identified by at least a version date so they can
be distinguished from previous versions.
Principal Investigator
Enter the name of the Local Principal Investigator.
Telephone number
Enter the telephone number where the Local Principal Investigator (PI) can be reached. This
facilitates access to the Investigator should questions arise regarding the “Change in Status”. If
your project has a Research Coordinator (RC) or Research Assistant (RA), Ethics Services will
contact them with any questions that arise unless otherwise instructed. Please enter the PI
telephone number only.
Horizon Health Network (HHN) File Number
Enter the File Number assigned by Ethics Services or Research Services to your study.
Note be entered on any documentation submitted in relation to the study. This will ensure more
efficient processing of the Change in Status Form.
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If your study was submitted and approved by a Research Ethics Board other than Zone 2/Saint
John (prior to the convening of the Horizon Health Network REB on October 21, 2009) you will
not have an AHSC or Horizon Health Network File Number. You will have a File Number that
was assigned to the study by the REB that served your zone. This File Number will be
maintained for the complete duration of the study (closing and archiving). If this describes the
situation at your study site, please leave this field on the form blank. Your File Number will be
captured elsewhere on the Study Change in Status Form.
(Non HHN) Local File# / REB Zone City
This data field applies to those studies outside Zone-2, Saint John that were underway prior to
the operation of the Horizon Health Network REB (October 21, 2009).
Enter the File Number assigned to the study and the REB Zone City of record. (Moncton or
Fredericton)
2. Status:
Premature, Early or Unplanned Change in Status
Provide a brief explanation why there is a premature, early, or unplanned change in the status
of the study. Attach any correspondence from the sponsor that describes what actions have or
will be taken to maintain participant safety and to inform current participants. Please do not
write “See attached”.
2.1 – 2.8) Study status change details
Check the box that describes the change that has occurred with the study and insert the date
of the change.
Closed to recruitment: Sponsor has closed recruitment. This is typically when global
recruitment is attained.
Study closed: This occurs when the study is closed locally. It may be due to the fact that all
local study participants have completed their study related visits, activities, or procedures. It
may also be a closure initiated by the sponsor due to the fact that the study site has not met
the recruitment goals set out by the contract.
Study close-out visit: The close-out visit takes place at the study site.
Study discontinued: The study is ending (terminating) prematurely. Closure is earlier than set
out in the study plan of the sponsor. The study may be discontinued by the sponsor or a
regulatory authority.
Study FINAL completion: This will not be applicable to most studies. All study participants
have completed participation in the study (visits, activities and procedures), AND completed
the observation period following the study. The observation period is the period of time that a
participant is followed from their point of completion of study visits to the point of reaching a
specified outcome. (For example, Oncology studies may follow participants to end of life.
When the final participant of the study has reached this outcome, the study has reached final
completion.
Study suspended: The study may be temporarily stopped for a period of time by either the
sponsor, or a regulatory authority. This is more than just a suspension of recruitment and
potentially has greater impact for participants who are already enrolled in the study and taking
part in study related activities. If this is the situation with your study, please provide detailed
information on what actions have or will be taken to maintain participant safety and to inform
current participants. This is a significant change that will require detailed reporting to the
REB.
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Study re-initiated: A study that has been suspended is now being re-initiated. Please provide
details on how this process will occur, particularly what actions have or will be taken to advise
participants who were taking part at the time of study suspension. This is a significant
change that will require detailed reporting to the REB.
Recruitment suspension: This most often occurs when there is an amendment to the protocol
by the sponsor that necessitates recruitment of potential participants be put on hold until the
amendment is approved. Ongoing study participants continue in the study as usual.
Recruitment re-initiated: Recruitment activities are reinstituted. This most often occurs after an
Amendment of a protocol has been approved by the REB.
3. Recruitment Update:
Please enter data for your site since the beginning of the study ONLY (since final approval
was given by the REB to start the study). The source of recruitment information may be the
recruitment log, contract, or application form.
Plan to recruit: is the number of participants to be recruited for the duration of the study (as
negotiated with the sponsor).
Actually recruited: is the number of participant(s) who have signed consent. If a
guardian/parent signs a consent and a child signs an assent, it counts as 1 participant.
Presently active: is the number of participants still taking part in study related visits, activities,
or procedures regardless of whether they are receiving intervention (drug or device) or not. For
example, if a participant is no longer receiving the study treatment but they continue to come to
the visits and complete the questionnaires, or examinations – they are still considered active.
Completed: is the number of participants who have signed the consent (or assent if
applicable) and completed all the study related visits, procedures and activities.
Withdrawn/Discontinued: is the number of participants who have signed the consent (or
assent if applicable), and at some point in time:
- the participant withdrew consent to continue their participation in the study. This could be due
to for example, a participant is not able to make it to study visits, study not what they thought
it would be, experiencing an intolerable adverse event, or they are moving. Ultimately, the
participant made the decision to withdraw.
- the Sponsor or the Principal Investigator (PI) discontinued the participant from the study. This
could be due to for example, the participant is a screen failure due to exclusionary screening
lab results, non-compliance, intolerable adverse event in which the participant may have
wanted to continue the study but the PI decided the participant needs to be withdrawn.
Ultimately the sponsor or the PI made the decision to discontinue the participant.
Follow-Up: is the number of participants who have completed the study and all related visits,
activities, or procedures and are still being observed (for the sponsor) by the Investigator to a
specified outcome (For example, Oncology studies may follow participants to end of life. The
participant will be considered in follow up until the outcome is reached.
4. Study Closed, Discontinued, Study Suspended, or Study Re-Initiated:
This section only needs to be completed when a study is ‘closed’, ‘discontinued’,
‘suspended’ or ‘re-initiated’.
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It is necessary to advise all parties involved in the study of changes in order to ensure that they
are up to date on the status of the study. The information regarding the change impacts each
area differently depending on the working relationship that has been established with the
department, nursing unit or office. (For departments providing a “service” it impacts workload
requirements for services provided, for nursing units it may impact recruitment or participant
care, and for Research Services it impacts billing/invoicing).
Depending on the Zone in which your study is being conducted, you may have different
reporting procedures with respect to the Research Services Office (RSO). Please contact your
RSO to determine what the procedure is when there is a change in the status of your study.
For Zone2: please forward any outstanding flow sheets within 10 working days of study
closure/discontinuation to Research Services.
For All Horizon Health Network
4.1) Departments and Units involved in the study
Please check the boxes on the form to indicate the departments and nursing units involved in
the study.
Send a copy of the completed Study Change in Status Form (to Research Services, and
any department involved in the study). Please advise nursing units involved in the study
of the change (they may not necessarily need a copy of the form).
4.2) At Study Closure
- Within 90 days of study closure: send a final report of your local activity for the study.
- Please remember to send to the Research Ethics Board a copy of any abstract or publication
that results from this study, even if it is after final closure of the study by the sponsor.
5. Identification:
Signature
The Local Principal Investigator must review the Study Change in Status Form, print their
name, sign, and date the form in the identified spaces before submission to Ethics Services.
Once the Study Change in Status Form has been reviewed the original Study Change in
Status Form will be returned to the Principal Investigator or their Research
Coordinator/Assistant.
The last section of the form (shaded area) provides information relating to the REB review of
the Study Change in Status Form.
Shaded Areas (Investigator Research Coordinator/Assistant) Please Read
For use by the Research Ethics Board only.
This area of the form will be utilized by Ethics Services and the Research Ethics Board. The
Study Change-in-Status Form will be reviewed and signed by a Primary Reviewer.
Recruitment suspended, re-initiated, ceased or study closed: The original Study Changein-Status Form signed by the Primary Reviewer will be returned to the Principal Investigator. If
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the Chairperson (or delegate) of the REB wishes to make a comment it will be written here.
The information from the Study Change-in-Status Form will be reported to the REB at the next
regular meeting. A copy will be retained for the study file.
Study prematurely discontinued, suspended or re-initiated: The original Study Change-inStatus Form signed by the Primary Reviewer will be returned to the Principal Investigator. If
the Chairperson (or delegate) of the REB wishes to make a comment it will be written here. A
copy of the Study Change-in-Status Form and supporting documentation will be submitted to
the next regular meeting of the Research Ethics Board for review and acknowledgement.
Thereafter, a letter from the REB Chairperson will be forwarded as acknowledgement of
review. Any additional action required by the REB will be described in the letter.
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