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ASR (Annual Safety Report)


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Clinical Development

Term used to describe the cross-functional and cross-departmental activities that are required to bring an investigational product from Phase I through Phase IV.
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Inspection

An inspection is conducted by a regulatory authority(ies) whereas an audit is conducted by the sponsor's auditor.

According to ICH-GCP, an inspection is an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial (under scrutiny) and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies) - see ICH GCP §1.29.

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Suspected Serious Adverse ...


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Site Management Organization

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BDRM (Blind Data Review ...


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Small and Medium Size ...


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Statistical Analysis Plan ...


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Mutual Recognition


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Marketing Authorization ...


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Drug Master File

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Data Standards Manager (DSM)


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Marketing Authorization


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MAA

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medically qualified personnel

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Serious Adverse Event (SAE)


An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:

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Good Manufacturing Practice ...


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Investigational Medicinal ...


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Service Level Agreement


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Marketing Authorization Holder


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