SUSAR/USADE Line Listing Report

Throughout a research project, the Coordinating Principal Investigator (CPI) must submit six-monthly listings of all Suspected Unexpected Serious Adverse Reactions (SUSARs) or Unanticipated Serious Adverse Device Effects (USADEs) to the reviewing HREC. An Annual Safety Report or updated safety reference document must also be submitted to the reviewing HREC. For information on safety reporting, refer to the NHMRC Australian Health Ethics Committee (AHEC) Position Statement (2009).

The CPI must submit this SUSAR/USADE Line Listing Report, attached to the relevant safety information, to the reviewing HREC. The CPI should provide a copy to the Principal Investigator (PI) at each site and the Research Governance Officer (RGO) at their own site.
Responses must be typed into the form; do not write responses by hand (except signature).
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Также: https://www.google.ru/search?q=SUSAR LL line listing&newwind...

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Note added at 23 мин (2021-09-28 10:40:23 GMT)
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Sorry for the typo: Line Listing

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Note added at 42 мин (2021-09-28 10:58:29 GMT)
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