Protocol Deviation Functionality In Siebel Clinical (CTMS) (Doc ID 2173948.1)

Last updated on JUNE 23, 2017

Applies to:

Siebel CRM - Version 8.1.1.10 [23021] and later
Information in this document applies to any platform.

Goal

Is capturing & tracking Protocol Deviation  part of the core functionalities of Siebel CTMS ?

Protocol Deviation: Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff. A deviation may be due to the research subject’s non-adherence, or an unintentional change to or non-compliance with the research protocol on the part of a researcher.

Since Protocol Deviations are very closely related to CTMS entities, it usually fits as a core CTMS functionlity and can easily be tracked within the CTMS product.

Siebel Clinical guide does not say anything about it.
Does Siebel CTMS has any Protocol Deviation functionality? Also is there  any future plan to include the same in future versions of Siebel CTMS?
 

Solution

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