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Will a Protocol / Study Number Format Change To 12 Characters have any Adverse Effects in AERS ? (Doc ID 1279058.1)

Last updated on JANUARY 14, 2011

Applies to:

Adverse Event Reporting System - Version: 4.5.2 and later   [Release: 4.5 and later ]
Information in this document applies to any platform.


The protocol number format (Study ID) is being changed at customer site from 6 characters to 12 characters.

The new format will now consists of a compound # and a trial ID e.g 01308-012.

Need to know if this format change in the protocol number have any adverse effect on the out of box reports or any procedure for AERS.

Impact assessment is required before the change is made.


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