Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
► HANDWRITTEN FORMS WILL NOT BE ACCEPTED ◄
THIS FORM IS FOR CONTINUING REVIEW ONLY.
IF THE STUDY HAS BEEN COMPLETED OR TERMINATED COMPLETE THE FINAL REPORT – MULTICENTER/REGISTRY
To be completed by the Sponsor/CRO or their designee at the time designated by Aspire IRB for continuing review
of the protocol (normally one year after initial review, but may be sooner).
Sponsor:
Protocol #:
Due Date:
Protocol
Title:
SECTION 1: REPORT TYPE
Report Type:
Due date:
Study Continuation – Subjects are still being seen
Closed to Enrollment – Subjects are still in follow-up or data collection is continuing
Study has not begun – note reason below
Study Cancelled or Terminated
Study is on hold
First subject not yet enrolled
Other (explain):
SECTION 2: PROTOCOL AMENDMENTS
Have there been any amendments / modifications to the protocol since the approval of the study?
Yes*
No
* Complete Appendix A and provide a summary of amendments / modifications
SECTION 3: SITE INFORMATION
All numbers should be cumulative totals, since the study began.
Please enter responses for each item below by providing information for sites approved by Aspire IRB only
Please be sure to enter a number for a, b, c and d and that a+b+c=d
a.
Number of sites actively participating in the study:
b.
Number of sites that have completed the study:
+
c.
Number of sites that have withdrawn or been discontinued from the study*:
+
*Complete Appendix B.
d.
TOTAL NUMBER OF SITES THAT HAVE PARTICIPATED IN THIS STUDY:
e.
Do you anticipate adding additional sites to the study?
No
=
Yes – if yes, how many?
SECTION 4: SITE MONITORING INFORMATION
Version Date: 04/01/2014
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Page 1 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
Please enter responses for each item below by providing information for sites approved by Aspire IRB only.
a.
Please describe how sites have been monitored for this study:
b.
Have any deficiencies/non-compliance been found that might represent an increased risk to study subjects?
No
Yes Has Aspire been notified of these additional identified risks?
No – attach an explanation
Yes
c.
Have any general informational or alert letters been sent to the sites about frequently occurring GCP/non-compliance deficiencies
identified through the monitoring process?
No
Yes – please attach copies of this / these item(s).
SECTION 5: SUBJECT INFORMATION
Please enter responses for each item below by providing information for sites approved by Aspire IRB only
a.
What is the subject enrollment goal for the study/protocol?
b.
What is the anticipated date of last subject enrolled?
c.
What is the anticipated date of last subject completed?
d.
Have there been any subject complaints about the research since the last IRB review?
No
Yes – please attach a summary.
Please attach a summary of the reasons for subject withdrawals / discontinuations since the study began.
SECTION 6: SAFETY MONITORING INFORMATION
Please enter responses for each item below by providing information for sites approved by Aspire IRB only.
Please attach a summary of unanticipated problems involving risks to subjects or others since the last IRB review.
a.
Has the Sponsor acquired any information that materially changes the potential benefits of the study as described in the original
protocol and consent form?
No
Yes – please explain (attach separate sheet).
b.
Is there a DSMB for this study?
No
Yes Please provide all DSMB meeting dates since the last IRB review
Have copies of DSMB reports been provided to Aspire IRB?
No – please provide copies for all dates reported above
Yes
c.
Have Safety Reports been submitted to the FDA for the study drug?
No
N/A
Yes – please provide a listing of all Safety Reports submitted to FDA, including dates
Version Date: 04/01/2014
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Page 2 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
d.
Has the Sponsor noted any trends or patterns in relation to AEs, Safety Reports or DSMB findings to date that suggest any
increased risks to subjects in the study?
No
Yes- Has this information been provided to study sites?
No
Yes - please attach copies of the information provided to the sites that has not been previously provided to Aspire IRB
e.
Has the Sponsor conducted timely information searches (including literature searches) regarding the test article?
No
Yes Has this information been provided to study sites?
No – please explain why not
Yes Have the results of the information search suggested an increased risk to subjects enrolled in this study?
No
Yes – please attach a summary
f.
Has any new information regarding study risks been communicated to study subjects in any form other than the Informed
Consent Document?
No
Yes - please attach copies of communication(s) provided to subjects and not previously provided to Aspire IRB
g.
Has there been a change to the Sponsor’s assessment of the risk/benefit ratio based on study results?
No
Yes – please explain
SECTION 7: RESEARCH STATUS REPORT CHECKLIST
The following information must be completed in Appendix C with your Research Status Report Form by the submission deadline in
order to be guaranteed placement on the agenda:
Date of Current Protocol
Date of Current Investigator’s Brochure OR
Date of Current Package Insert
Date(s) of Current Multicenter Informed Consent Document(s)
Additional information that you feel may be useful to the Board in considering continuing approval for this protocol
N/A
Included – described below
As a representative of the Sponsor/CRO of this study, I certify that the information contained above is correct
to the best of my knowledge, as of
(insert date).
Sponsor/CRO Representative Name:
Title/Company:
Phone Number:
Fax Number:
Version Date: 04/01/2014
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Page 3 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
Email:
@
Signature of Sponsor/CRO Representative
Version Date: 04/01/2014
Date
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Page 4 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
APPENDIX A
Protocol Amendments & Addenda
None
Amendment/Addendum Number
Version Date: 04/01/2014
Date
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Consent Changes Made?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Page 5 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
APPENDIX B
Site Withdrawals & Discontinuations
(attach separate sheet if necessary)
NONE
PI Name
Version Date: 04/01/2014
City, State
Date of Withdrawal
Or Discontinuation
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Reason for Withdrawal or
Discontinuation
Page 6 of 7
Research Status Report Form
(Sponsor/CRO – Multicenter/Registry Study)
APPENDIX C
(Section 7, Research Status Report Form Checklist)
DOCUMENT TITLE
Version Date: 04/01/2014
Aspire IRB, LLC
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
DATE OF CURRENT
DOCUMENT
Page 7 of 7