In the Post-Review state for a study being closed, the study closure letter template is presented instead of the approval template. The letter, along with the closure e-mail notification that is sent, inform the PI of the study closure. Combined and Separate Modifications and Continuing Reviews Modifications and continuing reviews can be created either separately or combined into a single submission. Combining them often makes sense. For example, suppose the study team wants to submit a consent form change about the same time that a continuing review is due. Both can be submitted and reviewed together, reducing the overhead for the study team, IRB staff, and reviewers. Caution for separate modifications and CRs: In one situation, separate modification and CR submissions that are open concurrently can both affect the attached documents. This creates potential contention over the finalization and stamping of documents. Contention can occur when a CR (or a combined modification / CR submission) is open concurrently with a separate modification that includes other parts of the study (not limited to study team membership). To handle potential conflicts in these situations, we recommend this approach: Approve the modification first before approving the CR (completing it through the Send Letter activity). This prevents contention. If you must approve the CR first, be aware that the modification will later overwrite the stamping of documents done by the CR. To correct this, make sure you finalize again in the modification all documents you finalized in the CR. Pre-Review for Modifications and Continuing Reviews Pre-review information is read-only for continuing review submissions and for modification submissions that are limited to study team membership changes. These types of submissions should not affect the pre-review information, so only the final question on the Submit Pre-Review form requires an answer. For modifications and modification / CRs that include other parts of the study, the Submit Pre-Review form is fully editable, and the answers update the study's pre-review information when the modification is approved. RNI Process Overview The basic process for reportable new information (RNI) is shown in the following diagram. The exploded view shows what occurs during the IRB review process. The legend indicates who can take major actions during each state within the process. Keep in mind that the diagram does not show all possible paths that a submission may take. The diagram shows the most likely path through the review process with common options identified. Unlike all other submission types, an RNI submission: Does not include ancillary review.
In the Post-Review state for a study being closed, the study closure letter template is presented instead of the approval template. The letter, along with the closure e-mail notification that is sent, inform the PI of the study closure. Combined and Separate Modifications and Continuing Reviews Modifications and continuing reviews can be created either separately or combined into a single submission. Combining them often makes sense. For example, suppose the study team wants to submit a consent form change about the same time that a continuing review is due. Both can be submitted and reviewed together, reducing the overhead for the study team, IRB staff, and reviewers. Caution for separate modifications and CRs: In one situation, separate modification and CR submissions that are open concurrently can both affect the attached documents. This creates potential contention over the finalization and stamping of documents. Contention can occur when a CR (or a combined modification / CR submission) is open concurrently with a separate modification that includes other parts of the study (not limited to study team membership). To handle potential conflicts in these situations, we recommend this approach: Approve the modification first before approving the CR (completing it through the Send Letter activity). This prevents contention. If you must approve the CR first, be aware that the modification will later overwrite the stamping of documents done by the CR. To correct this, make sure you finalize again in the modification all documents you finalized in the CR. Pre-Review for Modifications and Continuing Reviews Pre-review information is read-only for continuing review submissions and for modification submissions that are limited to study team membership changes. These types of submissions should not affect the pre-review information, so only the final question on the Submit Pre-Review form requires an answer. For modifications and modification / CRs that include other parts of the study, the Submit Pre-Review form is fully editable, and the answers update the study's pre-review information when the modification is approved. RNI Process Overview The basic process for reportable new information (RNI) is shown in the following diagram. The exploded view shows what occurs during the IRB review process. The legend indicates who can take major actions during each state within the process. Keep in mind that the diagram does not show all possible paths that a submission may take. The diagram shows the most likely path through the review process with common options identified. Unlike all other submission types, an RNI submission: Does not include ancillary review.
IRB%20Staff%20Administration%20Guide_7.6.1.docx