According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?

Upon completion of a clinical trial at a site, the investigator is required to provide the Institutional Review Board (IRB) with a final report. This report summarizes the trial's outcome, details the number of subjects enrolled, and describes any significant findings or adverse events. This submission formally notifies the IRB that the research activities are complete, allowing the IRB to close its file for the study and terminate its oversight responsibilities. This requirement is explicitly stated in the ICH GCP Guideline and is the established practice for complying with U.S. Code of Federal Regulations (CFR) regarding the conclusion of IRB oversight.

B. The monitoring close-out visit report: This is a report from the sponsor's monitor to the sponsor, documenting that site activities are complete and in order. It is not a required submission to the IRB.

C. The data safety monitoring summary: These summaries are typically provided to the IRB during the trial as part of the continuing review process to ensure subject safety, not as a separate, final submission after completion.

D. The final subject enrollment log: The IRB requires the final number of enrolled subjects, which is included in the final report. The entire log itself is a source document and is not typically submitted.

1. International Council for Harmonisation (ICH) Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), Section 4.13, "Final Report(s) by Investigator." This section states, "Upon completion of the trial, the investigator...should provide the IRB/IEC with a summary of the trial’s outcome..."

2. U.S. Food and Drug Administration (FDA), "Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Continuing Review After Study Approval" (February 2012), Section IV.B, "When Continuing Review is No Longer Necessary." This guidance clarifies that once a study is closed and all subject interaction and data analysis are complete, "...the investigator should submit a final report to the IRB."

3. Johns Hopkins University, Institute for Clinical and Translational Research, "Study Close-Out Procedures." The university's official guidance for investigators lists "Submit a Final Report/Study Closure Form to the IRB" as a mandatory step in the study close-out process, demonstrating the implementation of federal regulations in a reputable academic setting.

4. Code of Federal Regulations, Title 21, Part 56.109(f). This regulation mandates continuing IRB review of ongoing research. The universally accepted mechanism to end this requirement is the submission of a final report by the investigator, which allows the IRB to formally close the study.