Managing an FIU IRB Approved Project

The following guidelines are provided to assist investigators with managing FIU IRB approved protocols. All investigators are required to adhere to the Investigator Responsibilities outlined below.

Special Note: Studies involving a clinical trial and/or FDA-regulated drugs or significant risk devices are managed through Western IRB (WIRB) and therefore do not follow the same guidelines outlined below. Separate instructions for managing WIRB approved protocols are available on our Western IRB web page.

Investigator Responsibilities

Principal Investigators are required to:

  1. Ensure that no human subject be enlisted without prior informed consent.
  2. Keep signed consent forms for a minimum of three years after the completion of the study.
  3. Take all necessary safeguards to minimize risks and to protect the interests of vulnerable populations.
  4. Maintain the confidentiality of human subject data.
  5. Submit IRB annual renewals for active research involving human subjects (or human subject data).
  6. Submit IRB amendments to make changes to an approved protocol.
  7. Promptly report any injuries or other unanticipated problems.
  8. Assure the adequate training of their personnel.
  9. Adhere to high ethical standards.
  10. Comply with the Affirmation of Compliance on the applicable IRB Application Form.
Submitting Annual Renewals

Federal policy requires all studies approved in an Expedited category or by Full Board review be renewed at minimum annually (even if the investigator has not commenced recruitment of subjects). Annual renewal shall occur until all the data has been analyzed and all activity related to the project has ceased.

Renewal submissions are submitted via the “IRB Renewal Form” within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on “Create Renewal Protocol” to access the IRB Renewal Form in the TOPAZ system.

Investigators are responsible for ensuring that their protocols are renewed prior to their expiration dates. Investigators are not permitted to conduct research with human subjects once the IRB approval has expired.

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Submitting Amendments

Any additions or changes in the procedures involving human subjects must be submitted to the IRB for review and approval. Minor changes to an approved project that do not increase the risks to subjects will typically undergo an Expedited review. More than minor changes (or changes that increase the risks to subjects) will be reviewed by the Full Board.

Amendments are submitted via the “IRB Amendment Form” within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on “Create Amendment Protocol” to access the IRB Amendment Form in the TOPAZ system.

Alternatively, investigators can request amendments as part of their annual renewal (via the “IRB Renewal Form”) if the proposed changes are not needed until that renewal time frame. The renewal form will ask if there are any changes being requested and the investigator can then incorporate the proposed changes directly into the renewal form.

The IRB must approve the additions or changes PRIOR to them being implemented in the study.

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Reporting Adverse Events or Problems

The PI is responsible for reporting serious unanticipated events within 5 days, and non-serious events within 10 days of the occurrence. All key personnel need to be familiarized with AE procedures and aware of the appropriate contact persons in case of an event. The Adverse Event Table (AE Table) must be used with projects required to have a Data Safety Monitoring Plan.

Adverse Events are submitted via the “IRB Event Report Form” within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on “Create Interim Review Protocol” to access the IRB Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IRB Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IRB Coordinator via email. The IRB Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Reporting Adverse Events
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Reporting Protocol Deviations

The PI is responsible for reporting all instances that involve a deviation from the IRB approved protocol. A protocol deviation occurs when there is a variance in a research study between what is described in the protocol (reviewed and approved by the IRB) and the actual activities performed by the research team.

Protocol Deviations are submitted via the “IRB Event Report Form” within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on “Create Interim Review Protocol” to access the IRB Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Protocol Deviation, it is advised to first contact the IRB Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IRB Coordinator via email. The IRB Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Reporting Protocol Deviations
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Submitting Project Completions

The PI is required to submit a completion report when the study is no longer recruiting subjects, all the data has been analyzed, and all activity related to this project has ceased.

Studies completed prior to the end of the approval term need to submit their completion reports via the “IRB Project Completion Form” within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on “Create Interim Review Protocol” to access the IRB Project Completion Form in the TOPAZ system.

Log into the TOPAZ System
Learn about the TOPAZ System