USMA CONTINUING REVIEW REPORT
(Human Use Protocol)
Report Date:
Protocol Title:
Protocol Number:
Initial
IRB Approval Date:
Last Continuing Review Date:
Name of Principal Investigator/Local PI:
Department/MTF: Physical Therapy Sports Medicine Residency Program
Please answer all questions. If a question does not apply to the protocol, please put “not
applicable.” If continuing review is not completed and approved by the protocol expiration date,
your protocol will be suspended and all research activities must cease. If suspended, you may
not continue your study until the required information is received and approved by the IRB. You
must submit a copy of the current protocol, both the stamped and unstamped informed consent
form (as applicable), HIPAA Authorization form (if applicable), and any other required
documents, if applicable, as identified in this report.
1. Provide a concise overview of the protocol:
2. Describe the results/progress of the study since the last IRB review and approval:
3. Current status of study: (Check the appropriate statement)
a. No subjects have been enrolled. Explain why:
b. Research is active (Check the appropriate statement):
Research is still open to enrollment/specimen collection.
Research is closed to subject enrollment, but study remains active for subjects
receiving study interventions.
Research remains active for long-term follow-up of subjects.
Research remains active for data analysis only.
c. Request closure of protocol. Explain why (e.g., research and data analysis
complete, study never initiated, sponsor request). Be sure to explain the final deposition
of any data already obtained.___________________
d. Other (Describe, e.g., study suspended, on clinical hold):
4. Study Subjects (Complete each statement)
a. Total number of subjects (or specimens) approved for the study at USMA/MTF:
b. Total number of subjects (or specimens) approved study-wide (if multi-site):
c. Total number of subjects enrolled at USMA/MTF to date:
d. Number of subjects enrolled since last IRB approval:
USMA Version 1 dated: 10/2015
1
5. Protocol Amendments: Provide a summary of amendments occurring during this reporting
period.
6. Subject Withdrawals and Complaints (Check Yes or No)
a. Has any subject withdrawn or been withdrawn for any reason?
If Yes, describe the reason for withdrawal:
b. Has any subject complained about any aspect of the study?
If Yes, describe the complaint(s):
Y
N
Y
N
7. Were there any protocol deviations that occurred during this reporting period?
Y
N If yes, provide a list of all protocol deviations and the plans implemented to
prevent their recurrence.
8. Current Risk Benefit Assessment
Have you become aware of any relevant information or change that could affect the
risk/benefit status of the protocol?
Y
N If yes, please explain:
9. Confidentiality
Have there been any changes in measures used to protect participant privacy and ensure
confidentiality of data?
Y
N If yes, please explain:
10. Unanticipated Problems and Adverse Events (Check Yes or No to each statement)
a. Unanticipated problems involving risks to subjects or others (UPIRTSOs) have
occurred during this reporting period*
Y
N
b. Serious Adverse Events (SAEs) have occurred during this reporting period*
Y
c. Adverse Events (AEs) have occurred during this reporting period **
Y
N
N
*NOTE: If yes, attach a list summarizing all UPIRTSOs, SAEs, and/or deaths previously
reported to the IRB. If not reported, please explain why and submit a complete report.
**NOTE: If yes, attach an accounting of all AEs that have occurred during this reporting
period. For studies involving FDA-regulated products, summarize or attach any reports of
adverse drug reactions you received from the Sponsor of the study.
11. Study Monitoring and Trial Reports
a. Has this study been audited/monitored in the past year by any external auditors (e.g.,
AHRPO, FDA, Sponsor, USAMMDA, USAMRMC)?
Y
N
If yes, attach a copy of the audit/monitoring report with this continuation report.
b. Is this is a multi-site study?
Y
N
If yes, attach a copy of relevant multi-center trial audit/monitoring reports.
12. Recent Literature Search: Provide a summary of any recent literature that may be relevant
to this protocol. Include any new information found about risks associated with the research
(indicate if “no information is found”). Include date of most recent literature search.
13. List publications, presentations and abstracts resulting from this study. Please provide
complete citations. If there has been none, so state.
“This document is to be signed by the PI and a copy is to be retained within our records.”
______________________________________________________________________
PI Signature
Dated
USMA Version 1 dated: 10/2015
2