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Module 1: Lesson 1
Reports to IRB/IEC and sponsor
Master the investigator's reporting obligations throughout the trial lifecycle, including progress reports, safety reports, and final reports to both the IRB/IEC and sponsor.
Reports to IRB/IEC and sponsor
The documentation that fills regulatory binders represents more than compliance. It represents accountability. Every report an investigator submits tells a story about what happened at the site, how participants fared, and whether the trial is proceeding as planned. These reports are not bureaucratic exercises. They are the mechanism through which oversight bodies maintain visibility into trial conduct.
I have reviewed thousands of trial master files over the years, and I can tell you that the quality of reporting often predicts the quality of the trial itself. Sites that submit reports late, incomplete, or only when prodded tend to have other problems. Sites that maintain regular, accurate reporting rhythms tend to have their other documentation in order as well. This is not coincidence. Reporting discipline reflects operational discipline.
Section 2.13 of ICH E6(R3) Annex 1 addresses the investigator's reporting obligations. Where Section 2.4, which you studied in Module 6, established the framework for IRB/IEC communication, Section 2.13 addresses the investigator's obligations upon trial completion — specifically, informing the institution, providing the IRB/IEC with a summary of the trial's outcome, and submitting any required reports to regulatory authorities. This lesson also examines the broader reporting landscape, drawing on Section 2.4.5 for ongoing IRB/IEC status summaries and Section 2.7.2 for safety reporting, to give you a complete picture of the investigator's reporting responsibilities.
What you will learn
By the end of this lesson, you will be able to:
Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles