Quality analysis and improvement in Ethics committee

[Guest guest]

Good

morning members,

Now

I will discuss the reporting of Serious Adverse Events

Reporting of SAE:

As per institutional policies

· Differences in reporting rules

-

Ex.

All SAEs for foreign cases are reported, but may not be reviewed.

§ Are noted and filed.

§ No reports needed-

All

SAEs deviations and violations must be reported and discussed in the full board

meet of EC.

· Create a format for reporting SAE

usually all follow CIOMs format.

RegardsDr Sanjay Yallappa ChoudhariJR2,Dept of PharmacologyGMC, Nagpur

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