Portola was in the national media spotlight in 1996â1997 when a conflict occurred between the local community and the Department of Fish and Game over how to deal with an invasive species of Northern Pike in Lake Davis. The lake was chemically treated in 1997 to eradicate the fish, but they reappeared in 1999.
EXHIBIT 7A. PRINCIPLES OF DOCUMENTATION. NOTE: Principles of Documentation are merely guidance for surveyors and do not. impose obligations on either providers or surveyors for the suggestions contained in. them. Table of Contents. Introduction. Definitions. Legal Aspects of the Statement of Deficiencies. Overview.
2 Under 21 CFR 312.62(b), reference is made to records that are part of case histories as âsupporting dataâ; the ICH E6 Good Clinical Practice consolidated guidance uses the term âsource documents.â For the purpose of this guidance, these terms describe the same information and have been used interchangeably.. INTRODUCTION This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations.