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VA Long Beach Healthcare System
Status of Active Study Application
Instructions: Please complete all sections of this form. See “Submission Checklist Instructions” on the SCIRE website ( for all continuing review or closure submission requirements.
PRINCIPAL INVESTIGATOR (Last, First, M.I., Degree) / PROJECT NUMBER (MIRB) / DATE
PROJECT TITLE
1. Status of project Continuing Completed (Closure) Terminated
(If the project is continuing, then complete Sections b. through i. Otherwise, skip to Section 2.)
a. Is subject enrollment continuing? Yes No
If no, complete the following:
Is the research permanently closed to the enrollment of new subjects? Yes No
Have all subjects completed all research-related interventions? Yes No
Does the research remain active only for long-term follow-up of subjects? Yes No
Are the remaining research activities limited to data analysis?Yes No
b. Are subjects being seen for follow-up? Yes No N/A
c. Based on study results, has the risk/benefit ratio changed for this study? Yes No
If yes, explain.
d. Has there been a change in the PI, or the PI’s role in the study?
Yes No If yes, explain:
e. Has there been a change in the PI’s duties at the VA?
Yes No If yes, explain:
f. Have the physical or financial resources that are available to the study decreased since the last review? Yes No If yes, explain:
g. Has there been any change in research staff since the last review? Yes No
If yes, please list here:
h. Do you wish to make any changes in research staff at this Continuing Review? Yes No
If any personnel changes have been requested, or are being requested at this continuing review, please summarize the changes:
NOTE: If an individual obtains informed consent independently of an investigator, they must have completed an approved training program, and documentation of this kept on file by the investigator
2. Status of subjects:
a) Number of subjects (or charts/patient material reviewed if applicable)enrolled in study since last report? Since study began
b) Number of subjects approved to enrollat this site?
2.B: Minority, Female, and Vulnerable Subjects:
a) Number of female subjects since last report
b) Number of minority subjects since last report
c) Number of subjects considered part of a vulnerable population since last report
i) Indicate the reason subjects were considered part of a vulnerable population
ii) If a vulnerable population is being recruited:
iii) How do you continue to protect the vulnerable population?
2.C: Withdrawn/Screen Failure Subjects:
a) Number of subjects who signed consents but were dropped from study since last report (“screen failures”)
b) Total number of patients who withdrew or were withdrawn from the study since last report
Summarize the reasons for withdrawal
c) Total number of patients who withdrew or were withdrawn since the study began?
2.D: Non-Veteran Subjects:
a)Number of Non-Veterans enrolled
i)Have you created a CPRS record for the non-VA subject? No Yes
ii) Are you using clinical resources on the non-VA subjects? No Yes
(Such as: Radiology, cardiology, clinical laboratory & pharmacy)
iii)Have the subjects been admitted as in-patients? No Yes
2.E: Miscellaneous:
a) Did all research subjects give written informed consent since last report? Yes No N/A
If no, provide explanation:
b)If no subjects have been enrolled in this study, have any additional risks been identified?
Yes NoN/A
2.F: Subject Master List:
a) I certify that the “subject master-list” is updated and compliant. Yes No
If no, please complete the following section:
i)Is this a chart review? Yes No
ii)Is PHI collected? Yes No
iii)Have you requested an ICF Waiver? Yes No
3. Study Closure: If this is not a study closure, skip section:
a) Have all termination notes been completed for all enrolled subjects: (to un-flag their participation in CPRS): Yes No
If no, explain:
b) Confirm that you are aware that all original records are the property of the VA and may not be destroyed without proper authorization: Contact the R&D office for information regarding proper authorization.
c) If sponsored, does the sponsor require that the records remain on-site Yes No
If yes, for how long?
Note: If the sponsor does not require that the records remain on site, or if the project is unsponsored, then the closed records should be transferred to the Research Office for storage at Iron Mountain. The records will be maintained and disposed according to the VHA Record Control Schedule. Essentially, this means that the records will be eligible for destruction after 7 years from the study closure date. If you will need to have the records retained for a longer period of time, then you should contact the Research Office in order to make arrangements. More details about the retention of records are provided in the R&D SOP.
4. Serious Adverse Events and Unexpected Adverse Events
a)Have there been any complications, untoward side effects, serious adverse events, or unexpected adverse eventsat this site since the last report? Yes No
i)If yes, have all events been reported? Yes No
ii) Summarize all adverse events which occurred since the last IRB review:
b) Have any complications or untoward side effects been reported at other sites (SAE or IND Safety Reports) since last report? Yes No N/A
i) If yes, have all non-local events been reported? Yes No
ii) Summarize all unanticipated problems involving risks to participants or other since the last IRB review:
I certify that all serious or unexpected adverse events have been reported as required since the last IRB review.
5.Have any modificationsto the study (including sponsor amendments) been approved since the last review? Yes No
a) If yes, summarize the nature and purpose of all protocol modifications made since the time of last review:
6. Are you submitting any modifications to the study (including sponsor amendments) with this Continuing Review? Yes No
a) If yes, please summarize and include “Request for Modification of Approved Project” with this submission
b) Consent Form or Protocol changes must include: 1) old version (ICF stamped), 2) new version, and3) New version with changes clearly underlined. (no tracked changes.)
7. Have unanticipated risks or significant new findings been discovered since the last reviewthat might affect the subject’s willingness to continue participation?
Yes No. N/a (For chart review studies)
If yes, complete the following:
a) Explain the risks or findings in detail
b) Do these risks or findings require modification of the informed consent form? Yes No.
If yes, have the modifications been submitted to the IRB? Yes No.
c) Were subjects notified of these risks or findings? Yes No.
d) Were subjects reconsented? Yes No
8. Did any protocol deviations (including errors and accidents) occur since the last review?
Yes No If yes, summarize all protocol deviations:
I certify that all deviations have been reported, as required, since the last IRB review.
9. Advertising / Recruitment
a) Were there any changes to the planned advertising or recruitment methods described in the original protocol since the last review? Yes No N/A
b) If yes, summarize all changes that occurred:
10. Provide a summary description of study progress:Note: This section is required to be completed in order to receive IRB approval. Please complete this section in complete and full sentences. Please include global and local results.
Total numberof subjects enrolled:
Subject experiences:
Research results obtained thus far:
Any subject complaints about research:
Summary of subject benefits:
Any new scientific findings (or relevant recent literature available):
Any new information since the IRB's last review:
Please add any relevant multi-center trial reports (if applicable). Please attach summary of the DSMB or data monitoring committee meetings (if applicable) or findings based on the information collected by the data and safety monitoring plan submitted in the original protocol.
11. Provide the original IRB approval date for this project:
12. Clinical Trials.gov confirmation:
  1. Is there a sponsor to this study? Yes No
  2. Does the study involve a drug or device? Yes No
  3. Is an experimental group compared to a control group? Yes No
  4. If you have answered “yes” to any of the previous questions, please confirm the following:
  5. Include the required language in the ICF re: clinical trials. [refer to page 4 of ICF Template]
  6. I have verified that this study has registered with Clinical Trials.gov

13. Since last reported, has there been any change in the financial interests of the PrincipalInvestigator, any Co-investigator or their spouse or dependent child(ren) with respect to thesponsor or other entity external to the VA whose business interests are related to the data orresults of this study? Yes No N/A (unfunded) If “yes”, describe in detail the change infinancial interest. Use the space here or attach a separate sheet.
14. Has the Principal Investigator been an author or co-author on any published or submitted articles pertaining to this study since the last continuing review of this project?
Yes No If “yes”, include copies of all submitted/published work with this continuing review packet.
15. Since last reported, has there been any change in the use of pharmacy, laboratory or radiology resources of the facility for procedures or tests that are not clinically indicated?
Yes No N/A If yes, you must complete revised Impact Estimation Worksheets.
16. Since last report, have there been any changes to privacy and confidentiality or to how information is stored or transferred?
Yes No If yes, please explain in detail:
If Yes, does all VA sensitive research information continue to be used and stored within the VA?
Yes No If no, you will need to submit a revised ”Research Data Inventory Tool” and a revised "Data Use and Security Plan" with all necessary signatures.
17. Have you had any external study monitor visits since the last review? Yes No
a. If yes, were there any serious findings or concerns identified by the monitor? Yes No
If yes, please explain:
b. If yes, please attach all Study Monitor Reports and Follow-up Memos with this Continuing Review submission
18. CERTIFICATION: By signing this document, I attest that all the information I have provided is accurate to the best of my knowledge. I certify that the rights and welfare of human subjects participating in this research project will be protected at all times and that the benefits to be gained from this study are commensurate with the risks involved. An approved informed consent will be properly executed in every case and documented in the medical record. I have reported all serious adverse events and unexpected adverse experiences as required. I will immediately report any complications arising from this study to the Institutional Review Board (IRB). I certify that all investigators and all research staff who perform the informed consent procedure independently of an investigator have completed an approved educational program.
Principal Investigator / Date

VALBHS Cont. Review App Version Date: 9/1/2016

Replaces Version Date: 8/1/2015