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How MMS approaches New Investigator Updates To methodically move forward, MMS recommends considering these five checklist items: Discuss a monthly process for reviewing changes in site information, so that Appendix 16.1.4 can be properly updated Discuss with the transparency team what information should be updated on the ClinicalTrials.gov PRS and who is responsible for completing the updates Discuss the interest in having regular Transfer of Obligations updates To aid with this process, an intermediary record known as a Protocol Site Listing can be used to help to keep track of site modifications from the 1572 documents to Appendix 16.1.4 Determination applicable waivers and how to classify ex-US sites should be discussed It is recommended that the above aspects are discussed early on, preferably during the kick-off-meeting alongside other intricacies of the process including source documents, deliverables, timelines, and document signatories

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