Adventist HealthCare

Adventist HealthCare Institutional Review Board

Continuing Review Application

IRB Study #: Organizational Entity:

Study Name:

Principal Investigator (PI): Form Completed by:

|It is the Principal Investigator’s responsibility to ensure that continuing approval is obtained prior to the expiration date. Please contact the IRB |

|Office at (301) 315-3400 with any questions. Submit this application with associated documentation at least 45 days before the IRB approval expiration |

|date. No research activity may be conducted after the expiration date and no extensions can be granted. |

|Required Submission Documents: |

|Current AHC Site Protocol Application |

|Version Date |

|Current Sponsor Protocol N/A |

|Version Date |

|Most recently IRB approved consent/assent/authorization form(s) N/A |

|Current Investigator’s Brochure, drug inserts and/or Instructions for Use N/A |

|Version Date |

|Adverse Event Cumulative Table N/A |

|Protocol Deviation log N/A |

|All data and safety monitoring reports since the last continuing review N/A |

|Sponsor’s Annual/Interim Report if not previously submitted to the IRB N/A |

|Grant proposal, if new or revised application not previously submitted N/A |

|Related FDA communications since the last continuing review N/A |

|List of references of any publications on this topic or related to this study N/A |

|Monitoring reports/audit findings since the last continuing review N/A |

|Current Delegation of Authority Form N/A |

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|If Study Recruitment and Enrollment Continues: N/A |

|Microsoft Word copy of the most recently IRB approved consent/assent/authorization form(s) N/A |

|Questionnaires and surveys provided to subjects N/A |

|Recruitment materials N/A |

|Human Subjects Research |

|1. Status of the Research Study (choose one): |

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|Study is actively enrolling/access to data and/or specimens continues. |

|No subjects have been enrolled since the last continuing IRB review/approval. |

|Please detail why no subjects have been enrolled to date and include an action plan. |

|Study permanently closed to enrollment of new subjects, all subjects have completed all research-related interventions; and research remains active only |

|for long-term follow-up of subjects. Date closed to enrollment: |

|Study remains active only for data analysis. |

|Other. Explain: |

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|2. Enrollment Information: |

|a. Number of subjects/records/specimens approved at this site: |

|b. Enrollment Information N/A |

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|Since Last IRB Review |

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|Total |

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|Number of subjects consented and enrolled study-wide: |

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|At This Site |

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|Number of subjects consented and enrolled: |

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|Number of subjects consented, but not enrolled (i.e. screen failures ): |

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|Subjects who were removed from the study or withdrew early for the following reasons: |

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|Number due to adverse events |

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|Number due to other reason (specify: ) |

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|Number of subjects lost to follow-up |

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|Number of subjects who have completed all research activities: |

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|c. Racial and Ethnic Categories of Subjects Enrolled at this Site N/A: |

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|Please see for guidance on completing this table. |

|Racial Categories |

|Ethnic Categories |

|Total |

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|Not Hispanic or Latino |

|Hispanic or Latino |

|Unknown/ |

|Not Reported Ethnicity |

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|Female |

|Male |

|Unknown/ |

|Not Reported |

|Female |

|Male |

|Unknown/ |

|Not Reported |

|Female |

|Male |

|Unknown/ |

|Not Reported |

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|American Indian/ |

|Alaska Native |

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|Asian |

|Native Hawaiian or Other Pacific Islander |

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|Black or African American |

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|White |

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|More Than One Race |

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|Unknown or Not Reported |

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|Total |

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|d. Comments: |

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|3. Protocol and Consent: |

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|a. Have you followed the informed consent process as outlined in the AHC Site Protocol Application? |

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|Yes No If “No,” explain: |

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|b. Have all subjects signed and received a copy of the signed IRB-approved consent/assent form(s)? |

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|Yes No If “No,” explain: |

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|4. Safety and Adverse Events |

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|a. Based on your knowledge of adverse events that have occurred during the entire duration of this study, do you believe there is an increase in risks to |

|subjects? |

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|No Yes, Explain: |

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|b. Since the last IRB review, have there been any reportable events that were not reported to the IRB? |

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|No Yes, Please submit a completed Adverse Reporting Form. |

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|c. Have there been any protocol deviations that were not reviewed by the IRB? |

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|No Yes, Please submit a completed Deviation Reporting Form. |

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|d. Have there been any unanticipated problems involving risks to subjects or others? |

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|No Yes, Please submit a completed Unanticipated Problem Reporting Form. |

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|e. Have there been any complaints from subjects about the study or the conduct of any investigators, research staff, or hospital staff? |

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|No Yes, Explain: |

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|f. Has the study site been monitored/audited by a study sponsor or governmental (i.e. FDA) representative? |

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|No Yes, Explain the reason for the audit and submit a copy of the audit report and/or other relevant correspondence: |

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|g. Have any relevant interim findings, literature, reports or other information associated with research risks become available since the last IRB review?|

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|No Yes, Explain their implications for subject participation below and provide a summary or abstract of the findings. State whether a Sponsor report |

|has been submitted to the IRB since the last continuing review: |

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|h. Have there been any unanticipated benefits discovered since the last IRB review? |

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|No Yes, Explain: |

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|i. If the study has a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), has the DSMB or DMC issued any reports since the last IRB |

|continuing review? |

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|No Yes, Please include the reports with this submission. |

|Research Personnel |

|Has there been a change of principal investigator and/or have any key study personnel been added or removed from the study? |

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|No Yes, Please submit a completed Amendment Request Form. |

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|Have there been any changes in the status of board certification, licensure, or hospital privileges of any investigator on the study? |

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|No Yes, Explain: |

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|Are there any criminal charges or medical board complaints pending against any of the key study personnel on this study? |

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|No Yes, Explain: |

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|Has a Research Conflict of Interest been identified for any key study personnel on this study since the last IRB review? |

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|No Yes, Please submit a revised Research Conflict of Interest Disclosure Form. |

|Principal Investigator Certification |

|I have reviewed all the investigational data from this study, including a compilation of all adverse event, unanticipated problems and information from |

|the sponsor, including updated investigator brochures and data/safety monitoring board reports, as applicable, and conclude that: |

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|The risk/benefit ratio has not been altered; OR |

|The risk/benefit ratio has been altered. Modification of the research protocol and informed consent process are included with this submission. |

|SIGNATURE |

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|_________________________________________________ _____ |

|Signature of the Principal Investigator Date |

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