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protocol implementation; ensuring adherence to protocol requirements, Standard Operating
Procedures (SOPs) and Good Clinical Practice (GCP) principles.
1. Provide guidance to the study teams as regards protocol implementation.
process improvement, SOP development, and tracking and trending audit findings.
specimen collection and other study documents
Areports as may be applicable.
the protocol, policies, and to determine the accuracy of research records.
source documents, and Case Repot Forms (CRFs) to assess compliance, agreement, and
the source documents and CRFs in accordance with the requirements of the protocol.
for all the study sites
Skills & Competencies: