Instructions for Completion of Study Re

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STUDY RE-APPROVAL FORM
Guidelines for Completing the Form
The information provided on this form is used by the Research Ethics Board to ensure that, as
a study continues over time, regulatory, ethical, and local obligations are adhered to, progress
of the study is monitored, and safety of the study for participants is maintained. GCP and
regulatory bodies require, as a minimum, annual review and re-approval for ongoing research
involving humans.
Regulatory authorities and Horizon Health Network policy requires annual re-approval for any
study that will remain active (e.g. participant recruitment, participant follow-up, data collection,
data analysis) beyond one year from the original final approval date or last re-approval date.
One year is the maximum time period permitted by the current Horizon Health Network,
national, and international guidelines and regulations. The Research Ethics Board may, at its
discretion, require more frequent re-approval for certain studies.
The Study Re-Approval Form must be submitted 2 months prior to the anniversary of
the last study re-approval. If this is the first study re-approval: Submit 2 months prior to
the anniversary of the INITIAL REB meeting date for the study (REB meeting date
indicated on the Conditional Approval Letter).Ongoing approval from the REB will be
effective for one year from the day of the last approval or re-approval, unless otherwise
specified in a letter from the REB.
It is the responsibility of the Local Principal Investigator to ensure that study re-approval is
sought for each of their studies, and that the information contained in the Study Re-Approval
Form is accurate and complete. Study reminders are sent out by Ethics Services as a
courtesy, however, it is the Principal Investigator’s responsibility to ensure the re-approval is
submitted as required.
The Study Re-Approval 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 Re-Approval 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.
Expedited Review: Studies originally approved using the ‘Minimal Risk’ review procedure of
the REB are eligible for expedited review. In some circumstances a regulatory authority,
Version Date: September 2011
© Horizon Health Network - Ethics Services
Internal Working Document
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sponsor, or the REB may permit expedited review of a study originally approved by ‘Full REB
Review’ (e.g. some studies in which participants are only being ‘followed-up’). The Primary
Reviewer may not “disapprove” a study re-approval. If the Primary Reviewer identifies any
issues of significant concern, they are required to forward the study re-approval request to the
full REB for review at the next meeting.
Full Board Review. For study re-approvals that cannot be processed by expedited review, the
Study Re-Approval Form and attachments will be submitted to the REB for full board review at
the next regular meeting.
Please submit the following:
1 original completed Study Re-Approval Form
1 copy of the latest Data Safety monitoring Report (DSMB)
Please keep documents that will require an REB signature separate from other documents
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 the 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 that 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 “Study Re-Approval”.
If your project has a Research Coordinator (RC) or Research Assistant (RA), Ethics Services
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will contact them with any questions that arise unless otherwise instructed. Please enter the PI
telephone number only.
Last Re-Approval Date or Initial REB Meeting Date (1st re-approval only)
Enter the date the REB last granted re-approval for the study. (For Full Board Review Studies;
this is the “Meeting Date” under Research Ethics Board Review on the last Study Re-Approval
Form. For Expedited Review Studies; this is the “Signature Date” under Research Ethics
Board Review on the last Study Re-Approval Form.
If this is the 1st Study Re-Approval Form being submitted for this project; enter the INITIAL
REB meeting date for the study (REB meeting date indicated on the Conditional Approval
Letter).
Horizon Health Network (HHN) File Number
Enter the File Number assigned by Ethics Services or Research Services to your study.
Note: This is a unique identifier for your study and MUST be entered on any documentation
submitted in relation to the study. This will ensure more efficient processing of the Study ReApproval Form.
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 Re-Approval 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. Recruitment Update:
This section provides the Research Ethics Board with a summary of how your study is
progressing.
2.1) Recruitment Ceased?
Check the boxes to answer each of the questions, “At present, has recruitment ceased at this
site (permanently or temporarily)?”
If yes, enter the date recruitment ceased and check the box that describes the reason
recruitment has ceased. If recruitment has been suspended please ensure that a “Change in
Status” form has been submitted. The sponsor may suspend a study until the approval of an
amendment, however, the finalized amendment may not be received by the site for a period of
time due to it being under development by the sponsor. Therefore, it is important to advise the
REB that recruitment has been suspended.
2.2) Participants to be recruited overall (globally – all sites) for the duration of the study
-Enter the total number of participants to be recruited for all sites (globally) for the complete
duration of study. This information is found in the protocol and application form.
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Recruited means that the potential participant has signed the consent (or assent if applicable).
If a guardian/parent signs a consent and a child signs an assent, it counts as 1 participant.
2.3) Participants to be recruited at the site for the full duration of the study
-Enter total number of participants to be recruited for ONLY your site for the complete duration
of study. This information is found in the application form, and contract.
2.4) Participants that have been screened at the site since the last re-approval/approval
-Enter the number of participants screened at the site since the last study re-approval or if this
is the 1st re-approval submission, since the initial approval.
Screened means that you have discussed the study with the potential participant or you have
reviewed their chart/information for inclusion/exclusion (if you are within their “circle of care”) or
you have been given permission to do so by the potential participant.
2.5) Participants that have been recruited at the site since the last re-approval/approval
-Enter the number of participants recruited at the site since the last study re-approval or if this
is the 1st re-approval submission, since the initial approval.
2.6) Participants that have been withdrawn/discontinued at the site since the last reapproval/approval
-Enter the number of participants who have withdrawn/or were discontinued at the site since
the last study re-approval or if this is the 1st re-approval submission, since the initial approval
Withdrawn/Discontinued means that the potential participant has signed the consent (or assent
if applicable), and at some point in time either:
- 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.
2.7) Participants who have completed the study at the site since the last reapproval/approval
-Enter the number of participants who have completed all the study related visits set out in the
protocol at the site since the last study re-approval or if this is the 1st re-approval submission,
since the initial approval
Completed means that the participant has signed the consent (or assent if applicable) and
completed all the study related visits, procedures and activities.
2.8) Participants who are currently “Active” or in “Follow-Up” at the site.
-Enter the number of participants who are active at the site.
Active means the participant is 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
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participant is no longer receiving the study treatment but they continue to come to the visits
and complete the questionnaires, or have examinations – they are still considered active.
-Enter the number of participants who are in follow-up.
Follow-Up means the participant has completed the study and all study related visits, activities,
or procedures, however they 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. When
the participant reaches this outcome they are no longer in follow-up).
2.9) Anticipated Closure Date (globally).
Enter the date that is anticipated for the closure of the study by the sponsor. This date is found
on the Research Application Form.
3. Risk and Benefit Analysis:
3.1) New Information that affects the risk/benefit ratio of the study
Indicate if new information has become available, from any source (e.g. the literature, other
clinical studies), since the last study re-approval or if this is the 1st re-approval submission,
since the initial approval that impacts the risk/benefit ratio of the study.
It is possible that other studies could provide satisfactory evidence of the value, or lack of
value, of a medication, device, or treatment. Under such circumstances, it might become
unethical to continue with another study examining the same medication, device, or treatment.
The research team may become aware of such information more quickly, and the Local
Principal Investigator is obligated to make such information known to the Research Ethics
Board.
Where such new information is known, provide a succinct description in the Summary
Report section (Section 6). Continue on a separate sheet, if necessary, and attach it to the
Study Re-Approval form when submitted to Ethics Services.
3.2) New Information that ADVERSELY affects the risk/benefit ratio for study
participants.
Indicate if the new information that has become available, in the opinion of the Local
Principal Investigator, adversely affects the risk / benefit ratio for study participants,
since the last study re-approval or if this is the 1st re-approval submission, since the initial
approval.
Where such new information in the opinion of the Principal Investigator adversely
affects the risk/benefit ratio for study participants, provide a succinct description of the
adverse affects and describe any action that was taken to inform participants in the
Summary Report section (Section 6). Continue on a separate sheet, if necessary, and
attach it to the Study Re-Approval Form when submitted to Ethics Services.
3.3) Latest report from the Data Safety Monitoring Board (DSMB)
Attach a copy of the latest DSMB report. As part of the ongoing study safety analysis, the REB
would like to receive all DSMB safety reports.
4. Amendments:
4.1) Changes to the Protocol.
Check the box that indicates whether or not you have had a change to the protocol since the
last study re-approval or if this is the 1st re-approval submission, since the initial approval
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If you checked “Yes”, please provide the version number/date for the protocol that you are
currently using.
4.2) Changes to the Consent Form(s)
Check the box that indicates whether or not you have had a change to the main consent form
since the last study re-approval or if this is the 1st re-approval submission, since the initial
approval.
If you checked “Yes”, please provide the version number/date for the main consent form that
you are currently using.
5. Total Adverse Events:
Include only INITIAL REPORTS for Serious and Unexpected Adverse Events (termed
SUAE’s) that have occurred since the last study re-approval or if this is the 1st reapproval submission, since the initial approval.
5.1) Number of LOCAL SUAEs
Enter the number of local events (SUAEs). (Initial Reports only)
Note: A ‘local’ event is one that involves a patient recruited to the study at your study site.
Local refers to the study site and not the site where the SUAE occurs. For example, if the
participant experiences an SUAE while out of town or at another hospital, it is considered a
‘local’ event and needs to be reported.
5.2) Non-Local SUAEs
Indicate whether the Non-Local SUAE Reports have been submitted to the REB
Note: for multi-centered or sponsored research SUAE Reports (CIOMS, MEDWATCH, etc…)
are issued by the sponsor.
6. Summary Report:
DO NOT leave this section blank.
Use this area to provide a succinct description of progress and research activity for the study
(beyond the numbers provided elsewhere) since the last study re-approval or if this is the 1st
re-approval submission, since the initial approval, and to indicate your plans for the anticipated
re-approval period.
Include in the Summary Report:
- any changes to the protocol or the consent,
- a description of any new information that adversely affects the risk / benefit ratio for study
participants,
- details on any suspension of the study, how it impacts recruitment and how this impacts
current participants in the study,
- the plan for re-initiation of the study if applicable,
- plans for the next approval period.
This is an opportunity for the site to convey to the Research Ethics Board the ongoing success
and value of the study, and to address any potential concerns that may be anticipated.
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7. Identification:
Signature
The Local Principal Investigator must review the Study Re-Approval Form, print their name,
sign, and date the form in the identified spaces before submission to Ethics Services.
Once the Study Re-Approval request has been reviewed the original Study Re-Approval 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 Re-Approval 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. It will
indicate the type of review that was conducted for the study re-approval.
Expedited Review: The original Study Re-Approval Form signed by the Primary Reviewer and
co-signed by the Chairperson (or delegate) of the Research Ethics Board will be returned to
the Principal Investigator. The REB disposition will be indicated along with any REB comments
made. If applicable, the form will indicate a letter is included with the returned original Study
Re-Approval Form. Approval will be effective from the date the form is signed by the
Chairperson (or delegate) of the Research Ethics Board. A copy will be retained for the REB
file.
Full Board Review: The original Study Re-Approval Form signed by the Primary Reviewer
and co-signed by the Chairperson (or delegate) of the Research Ethics Board will be returned
to the Principal Investigator after the REB meeting that reviewed the Study Re-approval
request. The REB disposition will be indicated along with any REB comments made. If
applicable, the form will indicate a letter is included with the returned original Study ReApproval Form. Approval will be effective from the ‘Meeting Date’ shown. A copy will be
retained for the REB file.
If the Study re-approval request was denied, a letter will be attached to the original Study ReApproval Form describing the reasons for the disapproval and the steps to be taken to permit
re-approval.
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Instructions for Completion of Study Re

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