Care New England Institutional Review Boards (IRBs)
Request for Continuing Review or Closure of
Previously Approved Research Study
Use this form when submitting to the reviewing IRB(s) either (i) a request to renew the approval of a previously
approved study; or (ii) notification of the closure of a previously approved study. To request approval of a study
modification, please also complete and submit the Amendment / Modification Form.
Principal Investigator (PI):
Lead Coordinator:
IRBNet#:
Local Board Study Reference #:
Study Title:
Today’s Date:
Study Type: (check all that apply)
drug/biologic clinical trial
psychosocial intervention
medical device study
record review
survey/interview Procedures
specimen/tissue analysis or banking
other
Check one:
The PI hereby advises the reviewing IRB of the completion or other discontinuation of this study.
(Please complete sections I, III, and VII only)
The PI hereby requests the reviewing IRB to renew its approval of this study.
I. RESEARCH SUMMARY
a. Please indicate any preliminary results and/or interim findings.
b. Please list any manuscripts and/or publications that have arisen from this research.
c. Does this study have a data safety monitoring committee or other similar mechanism?
Yes
No
If yes, with respect to the most recent data safety monitoring report, please indicate:
(a) the date of the report: ____________________ (or “not issued” if report has yet to be issued)
(b) the date on which the report was submitted to the IRB: ____________ (if not submitted, please include with
this Request for Continuing Review)
d. Please briefly summarize any serious adverse events and/or unanticipated problems that have arisen in
this study since the last continuing review:
Revised: 12/15/2015
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II. ENROLLMENT STATUS
a) Please complete this sub-section (a.) if the study involves record review or specimen collection but no interaction or
intervention directly with subjects:
Check one:
Record selection or specimen collection is expected to continue. Estimate remaining time (in months or years): ____
Record selection or specimen collection is complete; individually identifiable information or specimens continue to
be reviewed.
Remaining research activities are limited to review or analysis of de-identified data or specimens. The IRB is
requested to allow this study to remain open because: _________________________________________________
~OR~
b) Please complete this sub-section (b.) if the study involves interaction or intervention directly with subjects:
Check one:
Enrollment is open. Estimate remaining time (in months or years) for continued enrollment:_______
Enrollment closed; subjects continue to receive/ undergo study medications/interventions/procedures or longterm follow-up assessments
Enrollment closed; remaining research activities are limited to analysis of individually identifiable data
Enrollment closed; remaining research activities are limited to analysis of de-identified data only. The IRB is
requested to allow this study to remain open because _________________________________________________
III. PARTICIPANT STATUS
Since First
Study
Approval
Number of Local Subjects1 Who …
Since Last
Continuing
Approval
Consented to participate
Enrolled
(received investigational treatments or participated in study procedures beyond screening for eligibility)
Screen failed
Are now “active”2
Have withdrawn/been withdrawn
Have completed all study activities including follow up
(Other subject count, if applicable)
(Other subject count, if applicable)
IV. CHANGES SINCE LAST CONTINUING REVIEW
(If this is the first continuing review, please report changes since initial approval)
1.
Procedural Changes: (please list all IRB-approved study modifications, including revisions to the consent
document(s), during the reporting period):
2.
Funding Changes:
3.
Changes in Potential Conflicts of Interest/Disclosures Relevant to this study:
4.
Changes in Study Personnel:
5.
Please describe all information concerning the safety or risks associated with the study that has arisen since the
last continuing review, and please indicate the actions that have been taken, or are proposed to be taken, to
communicate the information and mitigate risk.
“Local Subjects” means subjects enrolled by the investigator(s), or at the performance site(s), relying on this IRB for review and oversight of
the study.
2
For purposes of this form, “active” refers to currently enrolled patients who have not been withdrawn and who continue to receive or undergo
study-related treatments or other study-related interventions, if any.
1
Revised: 12/15/2015
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V. TRAINING AND COI DISCLOSURES
1. Have all investigators (key study personnel) undergone research ethics training?
Yes
No
2. Have all investigators (key study personnel) completed FCOI training in the past 4 years? Yes
No
3. NOTE: any investigator (or key study personnel) who has a change in his or her significant financial interests
(SFI, as defined by CNE policy) is required to send an updated version of their CNE SFI report form to the IRB
office within 30 days of the change.
VI. DOCUMENTATION AND ADVERSTISING RENEWALS
1.
Please identify by date and version the informed consent documents that need renewed approval.
2.
Please identify by date and version the advertising copy that needs renewal.
VII. FOR CLOSURES ONLY:
1.
Reason for Study Closure:
2.
Did all enrolled participants complete the planned study procedures? (do not include consideration of screen failures or
other elective participant terminations).
Yes
No: Explain below (include disposition of active participants if study closed prematurely):
VIII. ATTACHMENTS: (check all being attached)
Current ICF(s) to be renewed
Sponsor Correspondence
Signed FCOI Form (updated)
DSMB Minutes
Advertisement(s) for renewal
Other: ___________________________________________________
Revised: 12/15/2015
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