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Clinical Trial Toolkit

Supporting clinical trials at site

Dr Kara Vine-Perrow in IHMRI laboratories. Photo credit Paul Jones

clinicaltrialsNSW provide operational support for your clinical trial with centralised, standardised resources that support high quality trial conduct.

Our Clinical Trial Toolkit has the essential tools you need to establish your clinical trial in New South Wales.

Standard Operating Procedures for sites

The Office for Health and Medical Research (OHMR) have developed a suite of clinical trial (Site) Standard Operating Procedures (SOPs) for use in NSW Public Health Organisations.

They were developed to assist sites to conduct trial activities in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements.

The SOPs also help to ensure that sites meet the dual requirements of GCP:

  • to protect the rights, safety, and wellbeing of participants; and
  • to ensure the reliability of trial data.

How will these SOPs be implemented?

The SOPs can be downloaded and used at any time. All users are encouraged to provide feedback and suggestions for improvement, as well as any suggestions for additional SOPs during the current six month review period.

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Standard Operating Procedures templates

The zip files contains the following templates in PDF or Word format:

  • clinical trial training and qualification
  • hosting an audit or regulatory inspection
  • sub-contracting of external vendors
  • trial feasibility and start-up
  • delegation of duties by the principal investigator
  • informed consent
  • managing and reporting safety events
  • reporting non-compliance and suspected breaches of GCP or the protocol
  • investigational medicinal product management and emergency unblinding
  • source data and case report form completion
  • handling and transporting biological specimens
  • investigator site file and essential documents
  • close-out at a trial site
  • clinical trial archiving
  • work instruction site templates (customisable Word document for use by sites to document site-specific activities/procedures).
  • Standard Operating Procedures templates volume 1

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 2

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 3

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 4

    ZIP - 367 KB

Contact us on how to use the SOPs

GCP, safety and compliance guidance

Protocol

The Protocol is the document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organisation of a clinical research project.

Investigator’s brochure

The investigator’s brochure is a compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects:

Finance, contracts and intellectual property

Patient information

Provides information about a clinical trial to prospective participants and a mechanism for obtaining their written consent to participate.

Updated 2 weeks ago