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SCHN Policies
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The purpose of this document is to outline the Network’s policy and processes in relation to cash and cash equivalents received by the Network. Adherence to this document is expected to ensure that cash and cash equivalents received by the Network are deposited and recorded in a timely manner and easily tracked while keeping both, the funds and personnel handling the funds, secure and also guard against possible fraudulent activities. Sets out the policy and procedures for petty cash claims submitted by all SCHN employees. This document details the procedure for requesting and returning of cash float.
Overview of Child Safe Standards, from the Office of the Children's Guardian. The Royal Commission into Institutional Responses to Child Sexual Abuse recommended 10 child safe standards, drawing on its findings, research and consultation about what makes organisations child safe. this document will out line the 10 child safe standards and provide information for staff on how SCHN meet these standards with links to other documents and webpages. A child safe culture is a set of values and practices that guide the attitudes and behavior of all staff.
To provide guidance in relation to the Clinical Manual Handling Program and provide responsibilities and practical assistance to staff, i.e. Mentors, Managers etc
The purpose of this procedure is to describe the process by which access to the electronic medical record for the purposes of inspection for clinical research is managed at SCHN.
Establish guidelines and procedures for ensuring the authenticity, integrity, and legal compliance of certified copies of clinical trial documents and the use of electronic signatures. It ensures that electronic signatures are properly applied and that certified copies are acceptable for regulatory submissions, audits, and trial documentation, maintaining compliance with industry standards and regulatory requirements.
The purpose is to outline the procedure for accessing user support, notification of planned and unplanned downtime and obtaining access to electronic documents stored in the SCHN Clinical Trial Management System (CTMS) in the event of unplanned downtime.
The purpose of this procedure is to outline the activities, processes and documentation required during start up and initiation of a clinical trial conducted within the Sydney Children’s Health Network (SCHN).
• The purpose of this procedure is to ensure that close-out and archiving is performed in accordance with NSW Health, Sydney Children’s Hospital Network (SCHN), National Clinical Trials Governance Framework (NCTGF), International Council for on Harmonisation (ICH) Good Clinical Practice (GCP), regulatory and protocol requirements and best practice recommendations.
To provide clear guidance on what is required when obtaining consent to participate in human research conducted across SCHN.
The purpose of this procedure is to ensure the appropriate financial management of Clinical Research, in compliance with NSW Health, Sydney Children’s Hospital Network (SCHN), National Clinical Trials Governance Framework (NCTGF), International Council for on Harmonisation (ICH) Good Clinical Practice (GCP) and regulatory and best practice recommendations. Adherence to this procedure will ensure that: • Financial and operational risk to SCHN is reduced by ensuring that resources and funds are adequate, to conduct the Clinical Research to a high standard of quality and safety. In addition, the Supporting Departments involved in the delivery of the research are reimbursed for costs incurred; • Those departments conducting Clinical Research are meeting their financial obligations including completion of timely invoicing, receipting of invoices and reimbursements to Supporting Departments; • That there are appropriate Agreements in place to ensure those departments involved in conducting or participating in Clinical Research are remunerated as per the Agreement; • There is appropriate stewardship of public and other resources whereby funding is used ‘for purpose’ and the receipt, investment and expenditure of funds complies with NSW Accounts and Audit Determinations for Public Health Organisations; and • A high quality, efficient, sustainable and competitive service, delivered by experienced clinical and research personnel, is available to Investigators and Sponsors (or Delegates), now and in the future. • Reimbursement of out of pocket or other expenses incurred by clinical research participants during their involvement in clinical research is completed. The procedure must be followed by all personnel involved in the financial management of Clinical Research.
To cover roles and responsibilities, medical results review and training requirements for clinical trials/research
To outline the procedures for identifying, reporting, and managing instances where a clinical trial protocol is not followed or when serious breaches occur, ensuring participant safety and data integrity. It helps ensure compliance with regulatory requirements, facilitates corrective actions, and maintains transparency and accountability throughout the trial.
The purpose is to outline is to ensure that statistical analysis for clinical research sponsored by SCHN are developed, performed and reported, as applicable, in compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure the accuracy, validity and integrity of results drawn from the analysis of data for clinical research through use of appropriate statistical methodology and practices.
The purpose is to outline the procedure for the maintenance of essential documents as part of the TMF for clinical research, in compliance with NSW Health, SCHN and regulatory requirements
Governance of nursing clinical skill standards of assessment throughout SCHN
The purpose of this procedure is to describe the procedures related to use of a protocol, an Investigator Brochure (IB), and amendments to these documents for clinical trials used or developed by SCHN Investigators to ensure compliance with NSW Health, Sydney Children’s Hospital Network (SCHN), National Clinical Trials Governance Framework (NCTGF)2, International Council for on Harmonisation (ICH) Good Clinical Practice (GCP)15 and regulatory and best practice recommendations.
This policy outlines the application and review process for SCHN staff who wish to have SCHN take on Clinical Trial Sponsorship responsibilities.
Provides safety reporting process for all staff conducting research at SCHN.
To provide a guideline for hospital staff wishing to access data involving neonatal patients in Grace Centre for Newborn Care
This document provides background information regarding the processes required to develop a new Committee (and any associated working or project groups). The document clarifies the approval processes for the development of new committees and information on the administration of all committees within the Network. The document provides staff with templates to be used for all committee proposals, terms of reference, agenda and minutes.
Policy and procedures for visiting Company Representatives at CHW
The Sydney Children’s Hospitals Network (the Network) compliance management framework ensures the Network’s operations are conducted in accordance with legislative requirements and NSW Health Policy Directives.
To put in place a procedure for repairs to natural compressed air lines for plant & equipment for the maintenance department.
To promote promote personal health and well being by minimising the risk associated with alcohol consumption during events and functions and to provide information to staff on their responsibilities regarding the service of alcohol and related procedures.
To protect the integrity of the public health system and its staff, this policy and procedures define NSW Health's position in relation to conflicts of interest and gifts and benefits.
This document outlines the process for consumer feedback (complaints, compliments, suggestions or observation) management at SCHN. The procedure specifically provides strategies for dealing with complaints at the first point of contact, assessing the severity of complaints, investigating complaints and resolving complaints. The procedure also outlines the process for management of compliments, suggestions and observations.
The purpose of the Corporate Records Management policy is to ensure that full and accurate records of appropriate activities and decisions of the Sydney Children's Hospitals Network are created, managed and disposed of in accordance with the State Records Act 1998.
• Maintain the safety and quality of care that patients receive from Health Practitioners and employees. • Support best practice, ensure compliance with professional standards and meet accreditation requirements. • Sustain the confidence of the public and the professions. • Ensure the qualifications, experience, skills and other relevant attributes to fulfil the Scope of Practice are accurately described in the selection criteria of position descriptions. • Ensure credentialing and defining the Scope of Practice occurs at the point of consideration for employment and on an ongoing basis via the appraisal/performance review process or as required.