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.

Explains the policy expectations related to clinical incident management and responsibilities of local managers, Clinical Program Directors and CGU. Where to find additional information to clinical incident management as stated by NSW Health policy.

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.

The purpose of this procedure is to ensure that bio specimens for clinical research are collected in compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Bio specimens for clinical research are collected and processed in a safe and compliant manner by appropriately qualified and trained personnel to whom the Investigator has delegated responsibility; * The integrity of bio specimens for clinical research is preserved by ensuring that the bio specimens are maintained under suitable conditions during collection and processing; and * Appropriate records detailing the chain of custody for the bio specimens are maintained in compliance with the SCHN Procedure - Record Keeping [DRAFT]

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 ensure that close-out and archiving is performed in accordance with NSW Health, SCHN and regulatory and protocol requirements.

To provide clear guidance on what is required when obtaining consent to participate in human research conducted across SCHN.

The purpose is to outline the procedure for the creation of certified copies of original records for clinical research, in compliance with NSW Health, SCHN and regulatory requirements.

The purpose of this procedure is to ensure that deliveries of equipment and/or supplies (excluding IMP) for clinical research are received, processed, evaluated and stored in compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Investigators or Delegates receiving deliveries promptly identify that the delivery contains equipment/supplies for clinical research purposes; * Deliveries of equipment and/or supplies are promptly processed, evaluated and stored by the Investigator or Delegate.

The purpose of this procedure is to ensure that equipment/supplies for clinical research are appropriately maintained and calibrated (if applicable) in accordance with NSW Health, SCHN, regulatory, Protocol requirements and manufacturers guidelines. It is acknowledged that there may be some variations in the procedure for the maintenance and calibration of equipment/supplies depending upon the protocol-specific arrangements dictated by the Sponsor or Delegate. Adherence to this procedure will ensure that: * Responsibilities for the maintenance, calibration (if applicable) and inventory management are clearly defined and enacted; and * Equipment and supplies for clinical research are in good working order and available for use by Investigators or Delegates for their intended purpose;

The purpose of this procedure is to ensure the appropriate financial management of clinical research, in compliance with NSW Health, SCHN, regulatory and Protocol requirements. 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 and the Supporting Departments involved in the delivery of the research are reimbursed for costs incurred; * 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.

The purpose of this procedure is to ensure consistency in the performance of accountability tasks for IMP for clinical research, in compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Detailed records for IMP for clinical research are maintained providing details of all occasions of receipt, dispensing, transit/transfer, quarantine, return and/or destruction; and * IMP for clinical research is managed in accordance with the protocol-specific instructions of the Sponsor or Delegate and only used in accordance with, and for the purposes of the approved clinical research for which it has been provided.

The purpose of this procedure is to ensure that unused or unfit IMP that are authorised for disposal by the Sponsor or Delegate are processed in accordance with NSW Health, SCHN and regulatory and Protocol requirements.

The purpose of this procedure is to ensure that unused or unfit IMP identified by the manufacturer, Investigator, Sponsor or Delegate(s), as requiring quarantine is managed in compliance with NSW Health, SCHN, regulatory and Protocol requirements.

The purpose of this procedure is to ensure that deliveries of IMP for clinical research are appropriately received, processed and stored in compliance with NSW Health, SCHN, regulatory and Protocol requirements. It is acknowledged that there may be some variations in the procedure for the receipt and storage of IMP depending upon the protocol-specific requirements dictated by the Sponsor or Delegate, and in accordance with risk-assessments made by Pharmacy, as applicable. Adherence to this procedure will ensure that: * Pharmacy personnel receiving deliveries promptly identify that the delivery contains IMP for clinical research; * IMP deliveries are promptly acknowledged, processed and appropriately stored by the Senior Clinical Trials Pharmacist or Delegate.

The purpose of this procedure is to ensure that the quality and integrity of IMP is maintained in compliance with NSW Health, SCHN, regulatory and Protocol requirements through the monitoring of temperature in locations used for the storage IMP for clinical research. Adherence to this procedure will ensure that: * A valid, continuous record of temperature is available for all locations used for the storage of IMP for clinical research; and * Temperature deviations are promptly identified, escalated and acted upon, as appropriate, in consultation with the Sponsor or Delegate.

The purpose is to outline the procedure for the reimbursement of out of pocket or other expenses incurred by clinical research participants during their involvement in clinical research.

The purpose of this procedure is to ensure that the qualifications and training of clinical research personnel are documented and maintained to ensure compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Accurate records are maintained of the qualifications and training of clinical research personnel delegated to perform duties or tasks by the Investigator, under their supervision.

The purpose of this procedure is to ensure that a consistent approach is taken by SCHN Investigators with regards to the appropriate delegation of tasks and duties for clinical research, in compliance with NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this procedure will ensure that: * Investigators or Delegates appropriately assign duties or tasks to qualified and trained clinical research personnel operating under their supervision; * The delegation of duties or tasks by the Investigator is appropriately documented through completion and maintenance of a Signature and Delegation Log.

The purpose is to outline the procedure for the creation and management of records used as part of clinical research.

The purpose of this procedure is to ensure that all medical tests conducted for clinical research purposes are reviewed by the Investigator to ensure the safety of clinical research participants, adherence with the protocol and compliance with applicable NSW Health, SCHN and regulatory regulations. This procedure applies to all clinical research conducted within SCHN where the Investigator is responsible for reviewing medical test results to ensure clinical research participant safety and care, as per the protocol. This procedure applies regardless of whether such tests are performed at SCHN or by external agencies, such as central laboratories. Adherence to this procedure will ensure that: * Investigators promptly receive and review medical test results for clinical research participants under their care; * Investigators promptly act to review, escalate, respond and document any decisions made or actions taken, as a result of the review of medical tests to ensure the safety of clinical research participant under their care (as appropriate); and * Investigators respond in compliance with the requirements of the protocol (as applicable) and regulatory approvals, except when necessary to eliminate immediate hazards to the participant as per ICH GCP Section 3.3.7.

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 of this procedure is to outline requirements for the safe storage of chemicals, including flammable and/or corrosive agents for clinical research. It is acknowledged that there may be some variations in the procedure depending upon the recommendations and/or specifications for handling a specific chemical agent, with consideration of requirements as stated in its SDS, and in accordance with risk-assessments made by the responsible laboratory facility Head or Delegate.

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

The purpose of this procedure is to ensure the standardised and safe use of BSCs by clinical research personnel.

The purpose of this procedure is to ensure the standardised and safe use centrifuges by clinical research personnel.

The purpose of this procedure is to ensure the safe use of dry ice by clinical research personnel.

The purpose is to outline the procedure for the use of electronic signatures on records for clinical research, in compliance with NSW Health, SCHN and regulatory requirements. Adherence to this procedure will ensure: * Quality control systems and procedures are enacted to ensure the appropriate use of electronic signatures; * Improved consistency and efficiencies in workflow processes for clinical research personnel; and * Appropriate records detailing the chain of custody for original documents involving electronic signatures are maintained at all times;

The purpose of this procedure is to ensure the standardised and safe use of fridges and freezers by clinical research personnel.

The purpose of this procedure is to ensure the standardised and safe use of Fume Hoods by clinical research personnel.

The purpose of this procedure is to enable equitable access to, and effective communication with, people who require the use of interpreter services in order to consider and/or participate in clinical research. Adherence to this procedure will ensure that: * An inclusive and equitable approach to the opportunity for involvement in clinical research is taken; * Effective communication and/or support is provided to individuals prior to, and during, participation in clinical research; and * Appropriate records of the use of interpreter services are maintained in compliance with the SCHN Procedure - Record Keeping

The purpose of this policy is to ensure that laboratory facilities for clinical research are used in compliance with best practice guidelines as well as NSW Health, SCHN, regulatory and Protocol requirements. Adherence to this policy will ensure that: * Investigators or Delegates use laboratory facilities that are fit for purpose with consideration of protocol-specific requirements dictated by the Sponsor or Delegate, and in accordance with risk-assessments; * Laboratory facilities and equipment are used in a safe, equitable and compliant manner; and * Any data garnered from the performance of laboratory tasks is reliable and credible for analysis.

The purpose of this procedure is to ensure the safe handling of liquid nitrogen by clinical research personnel.

Governance of nursing clinical skill standards of assessment throughout SCHN

The purpose of this procedure is to ensure that Investigator’s Brochures (IB) developed or used by SCHN Investigators for clinical trials comply with NSW Health, SCHN and regulatory requirements.

The purpose of this procedure is to ensure that protocols being developed by SCHN Investigators comply with NSW Health, SCHN and regulatory as well as 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.