KUMC INSTITUTIONAL REVIEW BOARD
CONTINUING REVIEW SUPPLEMENT
Directions: Download this form to your desktop/files. Complete it and upload this form in the eIRB Continuing Review tab, as a Supporting Document on question #5.
I. Study Information
Principal Investigator:Protocol Title:
IRB#
Date of report:
II. Type of Study (check one)
Retrospective Chart Review (Please skip to sections VIII - XI)
All other studies (Proceed with section III below)
III. Enrollment status (check one)
Still enrolling (new consent form(s) will be issued)
Closed to enrollment (no consent forms are needed)
Closed to enrollment (re-issued consent forms are needed)
Specify the reason for requesting consent forms
IV. Data and Safety Monitoring
A.What type of data and safety monitoring was approved for this project?
Data and Safety Monitoring Board (DSMB)
Data Monitoring Committee (DMC)
Other central monitoring entity; Specify
Medical Monitor designated by the sponsor (for multi-center trials)
Medical Monitor designated at the local level
Name:
Affiliation:
KUMC study team members only
B.For clinical trials: Have you uploaded the CRIS Adverse Event report or similar listing of serious adverse events or unanticipated problems on item #5 on the eIRB Continuing Review page?
Yes
No; provide explanation
C.For studies overseen by a DSMB or DMC: Have you uploaded reports from all DSMB/DMC meetings that have occurred since your last Continuing Review submission (see item #5 on the eIRB Continuing Review smart form page)?
Yes
No; provide explanation
V. Study Conduct
A.Does the KUMC PI hold the IND or IDE for this study? Yes No
(An IND/IDE is special permission from FDA to conduct a study
with an investigational product)
B.Is the KUMC PI responsible for study conduct at non-KUMC sites? Yes No
If yes, provide a summary of the PI’s activities, since the last IRB review, to ensure protocol adherence, obtain informed consent, monitor adverse events, and communicate with other IRBs and generally oversee the conduct of the study at all sites.
C.List the dates of monitoring visits by the pharmaceutical sponsor, CRO or independent
monitor, since the last IRB review.
Investigators are reminded to promptly submit a Report of New Information for any monitoring reports for which the sponsor determined the findings could affect the safety of participants or influence the conduct of the study. Additional information is available at:
VI. Recruitment and Enrollment under the kumc principal investigator
NOTE: The questions in this section relate to recruitment for all sites that are being overseen by the
KUMC IRB (i.e., sites that are relying on our IRB review):
“Enrolled” below means the number of subjects who participated in the study as a subject or control or the number of subjects whose data was collected for the study (for example, in the case of a registry).
- How many subjects have been enrolled since the last continuing review was submitted (i.e., in the past 12 months or past 6 months, as applicable)? (This number should be the same as the Subjects Enrolled “Since Last Approval” in item 1 on the Continuing Review form in the eIRB system.)
- Since the study started, how many total subjects have been enrolled at all sites that are being overseen by the KUMC IRB? (This number should be the same as the Subjects Enrolled “Total” in item 1 on the Continuing Review form in the eIRB system.)
- Since the study started, how many subjects signed a consent form but were later determined either not to be eligible (i.e., screen failures) or who never participated in the study?
- Since the study started, how many subjects have been withdrawn or removed from the study?
- What were the reasons for the withdrawals? (e.g., voluntary withdrawal, safety withdrawal, study-related death, non-related death).
VII. Informed Consent
A. Was informed consent obtained from all enrolled subjects?
N/A (No subjects have been enrolled)
N/A (For waivers of consent)
Yes
No If no, provide explanation.
B. For pediatric studies, have any current subjects turned 18 years old since thelast review and
thus need to be re-consented as adults?
N/A (Not a pediatric study)
Yes
No
If yes, how many subjects turned 18 since the last review?
C. Were any non-English speaking subjects enrolled since the last review?
No
Yes Number enrolled
If yes, how was consent obtained?
Short form in native language
Full consent form in native language
Other: Specify
VIII.Retrospective Chart Reviews Only (other users skip to section ix)
A. Study Status
Still obtaining or analyzing identifiable data
Analysis is limited to only data without any HIPAA identifiers
(You may refer to the IRB website on how to close your study)
B. Have there been any changes in:
Purpose of the study
No
Yes Specify:
Data elements to be collected
No
Yes Specify:
Data storage location
No
Yes Specify:
Data recipients
No
Yes Specify:
IX.Conflict of Interest for All Study Team Members
Prior to approval, a current COI disclosure form must be on file for all KUMC study personnel. The following questions relate to the study named in this application.
NOTE: Principal Investigators are responsible for addressing these questions on behalf of the entire study team.
*Immediate family is defined as spouse, dependent children and personal household.
(a) Yes NoWith regard to publicly traded entities, do any of the investigators
or their immediate family have financial interests in the aggregate
of at least $5,000 which are related to the sponsoring entity or in an
entity whose products or services are being evaluated?
Financial interests include:
- Honoraria,
- Income for consulting and speaker’s bureaus,
- stock/stock options , and
- sponsored travel
that have been received or acquired within the past year or are expected to be received or acquired during the course of the project.
(b) Yes NoWith regard to private entities, which could be the sponsoring
entity or an entity whose products or services are being evaluated:
-Do any investigators or their immediate family have anyequity interests (i.e., regardless if value) which may include:
- ownership interests, or
- stock holdings or options ?
-Have any investigators or their immediate family received remuneration in the amount of at least $5000? Remuneration includes, but is not limited to:
- consulting or speaker fees,
- management fees
received during the past year or are expected to be received or acquired during the course of the project.
(c) Yes NoIs any investigator, or their immediate family:
- a paid or unpaid member of an advisory or executive board, or
- have a paid or unpaid executive relationship
with the sponsoring entity or in an entity whose products or services are being evaluated ?
(d) Yes NoDo any investigators or their immediate family receive:
- gift funds
- educational grants, or
- subsidies or other financial support for professional activities
from the sponsoring entity or an entity whose products or services are being evaluated?
(e) Yes NoAre any investigators or their immediate family an inventor of, or
have an ownership or royalty interest in, any intellectual property
utilized in this protocol?
(f) Yes NoDoes KUMC or the KUMC Research Institute have an ownership
or royalty interest in any intellectual property utilized in this
protocol?
(g) Yes NoFor drug/device studies only: is the sponsor of the study a
different party than the manufacturer of the drug or device?
(h)If you answered “Yes” to any of the above, please describe in detail. Affirmative answers will be forwarded to the KUMC Conflict of Interest Committee.
X.Additional Information
You may use this comment box to provide the IRB with additional information or clarifications.
IX.Additional documents
As applicable, upload these additional items asSupporting Documents on question #5 in the eIRB system.
Device Accountability logs
FDA progress reports (for IND/IDE holders)
FDA correspondence about this study (if not previously submitted)
Protocol Deviation Summary Log (for FDA-regulated studies)
Thank you for your submission.
If you have any questions, please contact the HRPP – Wichita Office
at (316) 293-2610 or .
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RevisedJanuary 2018