What’s New in the BIMO Manual? Outsourced Services

In our previous posts in this series , we took a high-level view at the changes in the updated BIMO Compliance Program Manual for Sponsors and CROs and took a deep dive into the changes in the Selection and Monitoring of Clinical Investigators section. Today, we’ll look at a new section:  Outsourced Services. This section pulls some content from the Organization and Personnel section of the previous version of the manual, but adds a significant amount of new detail.

Inspectors are now directed to review sponsor procedures for vendor evaluation and selection and to verify that sponsors have selected vendors “based on their ability to comply with FDA regulations and follow GCP standards.”  This version also asks the inspector to review any preferred or prequalified vendor list that the sponsor maintains and to evaluate the criteria for inclusion on that list.

Whereas the prior version directed the inspector to review written agreements transferring responsibilities to a CRO, the update asks inspectors to obtain copies of all versions of written agreements, including master service agreements, statements of work, quality agreements, and service-level agreements for critical services, providing the following examples: “Site monitoring, drug management, data handling (e.g., EDC systems, Interactive Response Technology (IRT) systems), ePRO, registries used to capture clinical trial data, and other clinical outcome assessments (COAs), electronic system vendors, data management, statistical analysis, central laboratories, and safety management.”

Inspectors are asked to determine whether written agreements specify responsibilities for complying with FDA regulations and “who has the ultimate responsibility for approving final decisions related to each of the individual trial-related activities outlined in these written agreements.” This requirement is likely to present concerns, as not all contracts specify decision-making authority for individual contracted tasks.

Inspectors are also required to determine whether CRO employees are appropriately qualified and whether they were appropriately trained on protocol-specific topics. Although study-specific training is getting more attention in study teams these days, this level of definition and tracking remains a challenge for many teams.

Inspectors are asked to review audit SOPs, communication plans, escalation plans, and contingency plans, focusing on oversight as well as whose SOPs were followed and which processes were followed to address deviations.

Although BIMO inspections have typically covered many of these topics, the previous version of the manual had little of this detail. Sponsors and CROs will want to ensure that these topics are addressed explicitly in their storyboards.