Facilities and Capabilities

Facilities

Dedicated 4 bed Clinical Trial day unit

·        Secure storage for study-related documents and materials

·        Mini Lab for PK/PD/PGx processing

·        Rooms available for on-site monitoring and audits

Remote Monitoring

·        Electronic Medical Record (EPIC)

·        Electronic Investigator Site File (Florence)

GMO Therapy

·        Experienced in the handling and administration of GMO products.

Patient Care

·        Overnight in-patient admissions

·        Paediatric Intensive Care Unit

·        Emergency Department

Cardiology

·        ECG

·        ECHO

Medical Imaging

·        CT

·        MRI

·        X-ray

·        Ultrasound

·        Bone densitometry

·        Fluoroscopy

Nuclear Medicine

·        Bone scan (DEXA)

·        Thyroid scan

·        Thallium cardiac stress test

Other Services

·        Ophthalmology, Audiology, Dentistry, Neuropsychology, Physiotherapy, Dietetics.

·        Translation

·        Other services available as required.

Equipment

12-lead ECG

Stadiometer and digital weigh scales

PC-2 BioSafety Cabinet

Freezers: -80C and -20C (continuous temperature monitoring and alarm system)

Refrigerator

(continuous temperature monitoring and alarm system)

Centrifuges (refrigerated)

Vital signs monitors: Heart Rate; Blood Pressure; Pulse Oximeter

Tympanic thermometers

All equipment listed above undergo routine calibration and maintenance by The Royal Children’s Hospital Biomedical Engineering Department (BME).  Records of calibration and maintenance records are maintained by BME and are available to review on request.

Clinical Trials Pharmacy Facilities and Equipment

-20C and -80C Freezer for IP Storage (continuous temperature monitoring and alarm system)

Refrigerated and ambient IP storage (continuous temperature monitoring and alarm system)

Back-up power system

Extemporaneous Preparation

Vertical lamina flow hood

Horizontal lamina flow hood

Blinded and unblinded pharmacy services

SOPs LIST (available on request)

Space for monitoring

Standard Operating Procedures and Guidance Documents

Number

Name

Type

MCTC101

Florence eBinders Management

SOP

MCTC103

eISF Workflows and eSignature Reference Guide for Commercially Sponsored Trials

Guidance

MCTC214

Change of Investigator for Commercially Sponsored Trials

Work Instruction

MCTC164

Management of Temperature Controlled Storage

SOP

MCTC054

Handling, Processing, Storage and Transport of Biospecimens in Human Research

SOP

MCTC166

Management of Investigational Product

SOP

MCTC065

Study Start up for Clinical Trials

SOP

MCTC170

Archiving Clinical Trial Investigator Site Files

SOP

MCTC073

Access Parkville Connect for Trial Monitoring

Factsheet

RCH02225521.1

Informed Consent in Research

Procedure

RCH02228851.1

Parkville EMR - Appropriate Use for Research

Procedure

MCTCRCH01

RCH Pharmacy Destruction of Clinical Trial Materials

SOP

MCTCRCH02

RCH Pharmacy Dispensing Clinical Trial Materials

SOP

MCTCRCH03

RCH Pharmacy Receipt of Clinical Trial Shipments – NON GMO needing Ultra cold storage

SOP

MCTCRCH04

RCH Pharmacy Receipt of Clinical Trial Shipments – NON GMO – NON Ultra cold storage

SOP

MCTCRCH05

RCH Pharmacy Storage of Clinical Trial Drugs

SOP