What to file in Trial Status Reports (01.01.12)

[Kristine Donaty]

Hi
What types of reports do people typically file in Trial Status Reports (01.01.12)? And how do those reports relate (or not) to Site Monitoring?

Section 01.01.12 is defined as “Routine trial status progress report generated by the sponsor or 3rd Party and distributed to trial stakeholders” and refers to ICH guidance from section 5.18.4 (g) which is about Monitor’s responsibilities to ensure ‘that the investigator and the investigator’s trial staff are adequately informed about the trial.’
I work for an entity that is akin to a CRO, yet we don’t contract with site monitors to perform their work (it’s another entities responsibility), but we produce reports on enrollment, retention and disposition – as well as MANY others. So because of how the section is defined and what ICH guidance is used, we’re conflicted as to whether we should or should not file.

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