FORM: Continuing Review Application
Document No.:
Edition No.:
DOC-501 CR
1. Contact Information
Protocol Title:
IRB ID (if known):
Principal Investigator (PI)
PI E-mail:
PI College:
PI’s Point of Contact (POC)
(if other than PI):
POC E-mail:
For students Faculty Sponsor’s Name:
Faculty Sponsor’s E-mail:
001
Effective Date:
7 February 2016
Page:
Page 1 of 2
PI Phone:
PI Dept:
POC Phone:
Faculty Sponsor’s Phone:
2. Purpose of submission
(select appropriate request)
Request for closure?
Request for extension of approval period?
3. Current Study Status (indicate YES or NO for activities involving this research at this institution/site)
3.1 Subjects have been enrolled (consented). Note: A subject is enrolled if the subject or their representative gave consent
to participate in the research. For studies not requiring signed consent, a subject is enrolled if they were or are participating in the study
3.2 The research is permanently closed to enrollment of new subjects
(If YES, answer 3.3 through 3.7) (If NO, SKIP to Item 4)
3.3 All subjects have completed all research-related interventions1 and interactions2, including those related to
long-term follow-up
3.4 All collection of information about the subjects that is both private3 and identifiable4 is complete
3.5 All analyses of information that is both private3 and identifiable4 are complete (Can be checked if another
organization will do the analysis)
3.6 The remaining activities are limited to analysis of private3 and identifiable4 information
3.7 The remaining activities are limited to long-term follow-up of subjects
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
1Interaction
means communication or interpersonal contact between investigator and subject
means physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are
performed for research purposes
3Private means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is
taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not
be made public
4Identifiable means the identity of the subject is or may readily be ascertained by the investigator or readily associated with the information by the
investigator
2Intervention
4. Accrual of Subjects
4.1 How many participants/subjects have been enrolled?
4.2 How many participants/subjects have completed all research procedures?
4.3 How many participants/subjects left the study (withdrew) before they completed all research procedures?
Brief Summary of reasons for subjects’ leaving the study (if applicable):
4.4 Total number of participants/subjects enrolled (consented) in the study.
MSWord Document version (by UTSA IRB office) revised 10/02/15
Created by WIRB Copernicus Group, Inc. for University of Texas San Antonio
Number
FORM: Continuing Review Application
Document No.:
DOC-501 CR
Edition No.:
001
Effective Date:
7 February 2016
Page:
Page 2 of 2
5. Current Consent document
List the approval dates of the currently used consent
documents/scripts
6. Relative to all sited involved in the study, Since the last IRB continuing review:
6.1 Is there any new risk or benefit information related to this study, not previously reported to the IRB
6.2 Are you aware of any scientific publications, safety monitoring reports, interim findings, multi-center trial
reports, or any similar reports relevant to the risks or potential benefits of this study
6.3 Have you received any subject complaints about the study
6.4 Have there been any unanticipated problems involving risks to subjects or others not previously reported to
this IRB
6.5 Have there been any changes to the protocol, consent, or materials seen by subjects not previously
reported to this IRB
6.6 Have there been any problems listed in "INVESTIGATOR GUIDANCE: Prompt Reporting Requirements (HRP801)" not yet reported to this IRB
6.7 Do any personnel involved in the design, conduct, or reporting of the research have a "Related Financial
Interest"
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
“Immediate Family” means spouse, domestic partner, and dependent children.
“Related Financial Interest” means any of the following interests in the sponsor, or product or service being tested held by the individual or the individual’s
immediate family:
• Ownership interest of any value including, but not limited to stocks and options, exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation of any amount in the preceding 12 month including, but not limited to honoraria, consultant fees, royalties, or other income.
• Proprietary interest of any value including, but not limited to patents, trademarks, copyrights, and licensing agreements.
• Board or executive relationship, regardless of compensation.
• Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research
institute, academic teaching hospital, or medical center.
7. Brief substantive summary of the progress of the research [SUMMARY REQUIRED]
Enter summary here:
Submission Requirements
Provide the following documents with this application:
 Current "FORM: Research Personnel (HRP-201)" for this study.
 The following documents when they exist or are applicable:
o Sponsor’s progress report or annual report
o Investigator's annual report to FDA
Investigator attestation
By submitting this form, the investigator attests to compliance with "INVESTIGATOR GUIDANCE: Investigator Obligations (HRP-800)"
MSWord Document version (by UTSA IRB office) revised 10/02/15
Created by WIRB Copernicus Group, Inc. for University of Texas San Antonio