Initial Submission of New Protocol
The PI is responsible for submitting a new study application to the IRB and to receive IRB approval before human subject research can begin. This responsibility is often delegated to the CRC or regulatory coordinator. A new study application is completed through the eIRB. This requires completion of the eIRB submission forms and uploading study specific documents. Study specific documents include, but are not limited to a research summary, an Informed Consent Form, and applicable HIPAA forms. Templates of these forms are available for download from the eIRB website.
Access to the eIRB system is granted after the employee completes the required CITI training specific for Duke Medicine.
DUHS may rely on the IRB of another institution or organization to serve as a central IRB, or an independent IRB for review and approval of human research. The Duke IRB website provides the most up-to-date guidance on independent or central IRB activities.
DHHS regulations and FDA regulations require that an IRB conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year. The IRB requires a progress report and continuing review summary for all studies through the continuing review application submission. The progress report template is found on the IRB website. The IRB requires that the continuing review application be submitted at least 45 days prior to the protocol expiration date. Automated eIRB Reminder notifications are sent to the PI and CRC of an expiring protocol at 60, 45, 30 and 14 days prior to the expiration date. It is the responsibility of the PI to submit to the IRB and receive IRB approval of either a continuing review application or a final progress report.
Any study not meeting the annual review requirements will be administratively closed by the CRU.
The DUHS IRB requires that the PI promptly report to the IRB proposed changes in a previously approved research activity. An amendment submission is necessary for any change to an IRB-approved study protocol. This includes any changes to the way the study team conducts the study or changes in study personnel. Amendments may require a change in the consent form.
All adverse events that occur during a study are documented. They are classified as serious, related or unexpected.
Should a subject enrolled in a study experience a serious adverse event, the event should immediately be reviewed by the PI. All serious adverse events are required to be reported to the sponsor and IRB, and in certain situations, the adverse event(s) should also be reported to Risk Management, and the Medical Director of the CRU. Detailed information regarding determination and reporting of adverse events is located on the IRB website.
IND Safety Reports
Sponsors must report all serious, related or unexpected events to the FDA. These events are then reported to the sites of ongoing clinical trials. These IND safety reports are submitted to the IRB and further classified as reportable or non-reportable based on an evaluation of the event by the site PI.
Protocol Deviations / Violations
A deviation or violation occurs when the study protocol has not been followed. Regardless of the reason, these alterations must be submitted to the IRB for review.
End of Participation of Research Subject
Termination is defined as the time at which a research subject is no longer participating in a study. This may occur when:
- Participant has completed all study visits according to the approved protocol.
- Participant has completed all study visits that might generate a billable cost to the study. For example, subject has completed all billable study visits, but is in long-term follow-up for data collection only.
- Participant is withdrawn from the study by the PI.
- Participant withdraws consent to participate in the study.
- Participant is lost to follow-up while still participating in the study.
- Participant dies while participating in the study.
Upon a subject’s termination, the CRC or PI are required document this date in the MaestroCare system.