Modules

Core Module Information
Module title: Clinical Research - Legislation and regulation
SCQF level: 11:
SCQF credit value: 20.00
ECTS credit value: 10
Module code: NMS11159
Module leader: Janyne Afseth
School School of Health & Social Care
Subject area group: Nursing
Prerequisites

There are no pre-requisites for this module to be added
Description of module content:

Good Clinical Practice; EU Clinical Trials Directive; Research Governance; Regulatory Authorities; Independant Ethics Committees/Institutional Review Boards; Local Approval and Inspections/Audits
Learning Outcomes for module:

LO1: Conceptualise the different regulations and legislation that influence clinical research
LO2: Critically evaluate the impact of regulation/legislation on clinical research practice
LO3: Critically reflect upon the processes that encourage or impede the adoption of these
LO4: Critically evaluate how Regulations/legislation has impacted on the design of clinical research
Full Details of Teaching and Assessment

Indicative References and Reading List - URL:
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