Research Status Report Form

Research Status Report Form

(Sponsor/CRO – Multicenter/Registry Study)

SECTION 1: GENERAL SITE / STUDY INFORMATION / Due date:
Sponsor: / Protocol Number:
Protocol Title:
Report Type: / Study Continuation – Subjects are still being seen
Closed to Enrollment – Subjects are being seen, but no new subjects are being enrolled
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 or since the last reporting period?
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. Census numbers should not decrease from the last reporting period.
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c. / Number of sites that have withdrawn or been discontinued from the study*: / +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
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)
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
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:
Email: / @

APPENDIX A

Protocol Amendments & Addenda

None

Amendment/Addendum Number / Date / 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

APPENDIX B

Site Withdrawals & Discontinuations

(attach separate sheet if necessary)

NONE

PI Name / City, State / Date of Withdrawal
Or Discontinuation / Reason for Withdrawal or Discontinuation

APPENDIX C

(Section 7, Research Status Report Form Checklist)

DOCUMENT TITLE / DATE OF CURRENT DOCUMENT

Aspire IRB, Inc.

11491 Woodside Avenue

Santee, CA 92071

619.469.0108 (phone)

Version Date: February 15, 2017 619.469.4108 (fax) Page 6 of 6