A significant number of research groups at the University of Wisconsin-Madison serve as analysis centers for multi-site studies. Analysis centers provide core or central image reading or analysis, specimen analysis, or statistical data analysis for multi-site studies but are otherwise not involved in the conduct of the research. Research groups that provide such support for multi-site research studies may be considered to be engaged in human subjects research and thus IRB oversight of their activities by a University of Wisconsin-Madison IRB is required.

1. See HRP-311 to determine whether the institution is engaged. In some cases, the institution may not be engaged, and the study could be provided with a not engaged letter in ARROW.
2. If the project is Federally funded, it may be worth asking if we could cede IRB review to the coordinating site, given the single IRB (sIRB) mandate. But due to the limited nature of our institution’s involvement, in the past some coordinating sites have hesitated to want to have us cede.
3. Consult with RELIANT if there are questions about SDAC engagement and/or possible sIRB review.

1. The SDAC application includes a General Application Information (GAI) section with similar pages to other initial review application types (note that some GAI pages, such as study team roles, scientific review other than PRMC, and clinicaltrials.gov status, will be hidden, as these are not applicable to SDACs). 
2. The SDAC section includes two pages, with questions that fall into two main categories:
   1. A description of the overall study.
      1. This includes documents related to their IRB approval, such as a coordinating center, IRB approval notice, model consent form, and studywide protocol. The studywide protocol may or may not describe the specific role of UW-Madison.
      2. The study purpose and population are also described on this page, along with UW-Madison’s role in the study.
   2. A description of the data/image/specimen transmission between the other study site(s) and UW-Madison as well as local storage, access, and retention.

1. Use HRP-311 to determine whether UW-Madison will be engaged in human subjects research.
   1. If the institution is not engaged, send the study team a Not Engaged letter in ARROW.
   2. If the institution will be engaged, review the rest of the application.
2. For the main study procedures, the protocol and consent form can be used to determine whether FDA regulations may apply to the parent study. If so, the SDAC will require 12-month continuing review.
3. Parent study procedures do not need to be reviewed by the UW-Madison IRB, because that study will have already received IRB review.
   1. The protocol and consent form should be reviewed for consistency with the description of data sharing and analysis activities that will be conducted at UW-Madison.
   2. The IRB reviewing the parent study will make relevant determinations relating to FDA regulations, overall study risk level, and special populations.
4. All SDAC applications will be Minimal Risk because the UW-Madison IRB determination will only apply to local analysis activities.
5. The questions about receiving/returning data/images/specimens are similar to the Sharing of Data page found in other Initial Review applications and should be reviewed in a similar manner (for example, the study team should specify any HIPAA identifiers that will be transmitted with data or specimens). Consistent with HRP-309, the Ancillary Review Matrix, study teams are responsible for determining whether data or materials transfer and use agreements are necessary.

1. The Pre-Review Checklist HRP-401 can be prepared with information relevant to local determinations.
   1. Note the parent study purpose, FDA status, special populations, and HIPAA implications.
   2. Direct IRB members to review the UW-Madison activities only and note that the UW-Madison activities will constitute minimal risk.
   3. Note whether continuing review will be required.
   4. Check relevant boxes for Regulatory Oversight, special populations, and HIPAA.
2. Additional Checklists that would apply to the parent study (waivers or alterations of informed consent or HIPAA authorization, special populations) do not need to be completed.

1. Complete the Minutes regarding the local determinations made by the UW-Madison IRB. Where applicable, state that the parent study’s IRB is responsible for making the relevant determinations (e.g. regulatory findings for children).
   1. See the Full vs. Expedited Review guidance within the Continuing Reviews section of the Staff Manual for more information about continuing reviews for SDACs.
2. Post-Approval
   1. See the Investigator Manual for information about what changes should be submitted for analysis center studies.