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Protocol Information Office
An office within NCI which provides administrative support for clinical trial development and tracking by abstraction of key elements into a web-based relational database, monitoring trial timelines and activity from trial proposal to close-out, supporting document review and agent meetings, and developing metrics for program evaluation. (NCI Thesaurus)
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The description and the values of the components comprising Case Report forms.
Protocols, with Case Report Forms included, stipulate the execution of Clinical Trials.
Other important events that occur during a trial but are not driven by protocol requirements.
An image of reduced quality resulting from the use of incorrect or incomplete instructions.
The group of incidents that occur during a clinical trial and describe whether a subject completed the study epoch or the reason…
A clinical study protocol review status designating the protocol that was denied the approval.
