Intranet - The University of Sydney

Storage of scheduled drugs

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All drugs must be stored consistently with the manufacturer’s instructions, including instructions about temperature control and expiry dates. 

Researchers in possession of high risk drugs, Schedule 4D, Schedule 8 or Schedule 9 drugs (including dilutions), must keep the drugs stored:

• In a safe or other receptacle securely attached to part of the premises;
• Kept securely locked when not in immediate use;
• Only used to store drugs and no other goods, except for related documents; and
• Within a secure laboratory or animal facility.

Only authorised users listed on the NSW Authority to Possess or Supply Schedule 8 or Schedule 9 substances are permitted to have access to the storage for the drugs listed on the Authority.

Access to S4D drugs must only be given to authorised team members.

A drug register should be kept at the storage location of high risk drugs.

For any queries in relation to scheduled drug processes and procedures, please contact: scheduled.drugs@sydney.edu.au 

Research Funding Approval (RFA) – Introduction to the Pre-Award Approval Form

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This article provides a detailed guide on how to use the Pre-Award Approval Form to obtain institutional approval to apply for competitive research grants. It is intended to give users of the webform an overview of some key questions in the form, as well as the online workflow which automates requests for approvals from local areas across the university. This form replaces the previous requirement for USYD researchers to submit an Authority to Submit (ATS) PDF form to the Research Portfolio's Pre-Award and Pipeline team.

Please note that the Pre-Award Approval Form does not replace the requirement for researchers to submit a General Research Enquiry if they want to receive grant application assistance including funder compliance, eligibility and submission support from the Pre-Award submissions team.

You should use this form if:

• You are a USYD researcher who intends to affiliate themselves with the University of Sydney on a competitive grant submission, which can either be led by the University of Sydney or another organisation.

What is the difference between a Pre-Award Approval Form and the Research Funding Approval (RFA) service?

The Pre-Award Approval Form is the most common way for researchers to commence using the RFA service, since it is initiated at the beginning of the research grant lifecycle, during the application phase. The RFA service also contains a number of other internal university forms which may or may not follow automatically from a completed Pre-Award Approval Form, depending on the status of the full grant application with the funder. Both the Pre-Award Approval Form and the rest of the forms in the RFA s

Overview: Creating IRMA Academic Staff Profiles and TRO / NTRO Publication Capture

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Expiration and beyond use dates in scheduled drugs

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Drugs have three critical cease administration factors to manage when conducting research:

• Beyond use date (BUD)
• Broach date
• Expiry date (also known as product shelf life)

Drug use in animals or experiments must not violate any of these factors. Using drugs beyond these end dates can pose issues with both animal welfare, ethics and research integrity. For example, changes in drug solutions due to degradation or lack of sterility can impact the pain or discomfort an animal may feel, the effectiveness of an antibiotic or the duration of a procedure due to slower acting time of a sedative. Beyond animal welfare concerns, using a drug or dilution that may not be stable, has changed concentration, preservatives/additives have degraded or is contaminated with bacteria or fungi also has implications for the reliability and replicability of results in a study. Accordingly, a standard condition of all Animal Research Authorities (ARA) and a clause of the Management of drugs in laboratory and animal-based research procedures 2024 (section 11(2)) is that out of date or expired drugs must not be used on animals.

Summary:

Beyond use date – any drug dilution or solution must not be used beyond 1 month after creation*.

Broach date – best practice is to follow the stated broach date on bottles.

Expiry date – applies to unopened bottles stored appropriately following the manufacturer’s instructions.

*Exceptions for some drugs - please check detail in the guide below.

Principles of Research Data Management

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The value of research data increases when it is ability to be accessed, shared and stored is optimised. Maximise the value of your research data through meeting the principles of research data management.

What Core Research Facilities are available to researchers and how do I access them?

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The University’s world-class and openly accessible Core Research Facilities (CRFs) are geared to provide our researchers and partners with the infrastructure, tools and technical support to pursue research excellence. This article outlines the eight CRFs that are available and the steps you need to take to access relevant CRF. 

IRMA-ORCID Integration - Frequently asked questions

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This article aims to provide answers to some commonly asked questions about the IRMA-ORCID Integration.

• IRMA-ORCID integration processes

• Managing your ORCID profile

Project information and support ORCID identifier: Enhancing your global presence

The University implementation is scheduled for roll-out in June 2022. 
Support documentation will be updated as the functionality is fully implemented.

Guidelines on attribution of generative AI use for research students

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This work is licensed under CC BY-NC-SA 4.0

Attribution: Shannon Taylor, Research Data Consultant, Research Integrity and Ethics Administration, University of Sydney

Applying for a NSW Authority to Possess or Supply Schedule 8 or Schedule 9 substances

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This article outlines the procedures for applying for a NSW Authority to Possess or Supply Schedule 8 or Schedule 9 substances, Prohibited Drugs/Plants for the Purpose of Research, Instruction, Analysis or Treatment of Animals.

You must hold an authority or be listed as an authorised user on an authority issued through NSW Health Pharmaceutical Services to work with Schedule 8 or 9 drugs.

Information on Importing or Exporting scheduled drugs is included below.

Schedule 8 and 9 Drugs being used in Clinical Trials require different forms and governance processes, please contact clinical-trials.research@sydney.edu.au for advice.

For any queries in relation to schedule drug processes and procedures, including work occurring outside NSW, please contact: scheduled.drugs@sydney.edu.au

The expectations for working with scheduled drugs at the University can be found in the Management of drugs in laboratory and animal-based research procedures 2024.

Planning for publication of a Non-Traditional Research Output (NTRO)

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To ensure your NTRO will be eligible for inclusion in the annual Sydney Research Collection and in the University’s ERA submission, as well as counting towards your annual academic performance, it pays to plan ahead for the publication of your NTRO.

What is a Research Data Management Plan (RDMP)?

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A Research Data Management Plan (RDMP) is a document in which a researcher outlines how their research data is to be managed both during a project and after it is completed.

Project Budget Tool: A Front-to-Back guide to creating a project budget.

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This article provides a high-level step-by-step guide to creating a project budget with the Project Budgeting Tool (PBT). Each drop-down addresses a different section of the PBT, such as the Dashboard, Project Summary, Budget Detail, Budget Summary and Year-by-Year sections. If you are looking for scheme-specific details, such as DECRA salary shortfalls, or NHMRC PSP levels, please email us at research-budget.support@sydney.edu.au

Generative-AI: guidelines for researchers

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The recent and rapid emergence of Generative-AI (Gen-AI) tools presents many opportunities for research. The benefit these tools may bring to research and contribute to the public good is being explored by researchers across all disciplines. While 'the sky is the limit' in what these new tools may offer, there are identified risks that must be managed so that Gen-AI tools can be used safely in research.

These guidelines provide a simple set of considerations that all researchers need to take into account before using Gen-AI tools in research.

Transport of scheduled drugs

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This article outlines the procedures for transporting high risk scheduled drugs: Schedule 4D (S4D), Schedule 8 (S8) and Schedule 9 (S9).

If S4D, S8 or S9 drugs are stolen or lost (including spills and breakages), the reporting process must immediately be followed.

All drugs and medicines need to be managed to prevent access to non authorised users.

Transport of any drug/medication should follow the principles of this guide.

For any queries in relation to schedule drug processes and procedures, please contact: scheduled.drugs@sydney.edu.au

Record keeping of high risk scheduled drugs

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Researchers in possession of high risk drugs: Schedule 4D, Schedule 8 or Schedule 9 drugs, must maintain a drug register at each storage location.

All other drugs must be recorded in an appropriate and permanent manner, e.g. laboratory record or animal monitoring sheets.

If drugs or drug registers are lost or stolen, the reporting process must be immediately followed. Loss includes spills and breakages.

For any queries in relation to scheduled drug processes and procedures, please contact: scheduled.drugs@sydney.edu.au

myResearch Ethics glossary

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GenAI Publishing considerations

https://sydneyuni.service-now.com/sm?id=kb_article_view&sysparm_article=KB0034973

This work is licensed under CC BY-NC-SA 4.0

Attribution: Shannon Taylor, Research Data Consultant, Research Integrity and Ethics Administration, University of Sydney

How can I answer the research data management section of my HREA Project Description?

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The questions in the project description document and the human research ethics application relate to how you will protect participants’ privacy and the confidentiality of their information in your research project. Doing so requires you to:

• Follow best practice in managing your research data
• Use University-supported platforms
• Understand data classifications and handling requirements, particularly around controlling access to protect sensitive data
• Keep your Research Data Management Plan (RDMP) up-to-date

Here, we provide guidance on how to achieve this and to accurately answer these questions.

The example phrases provided can be used in your application, if you follow the procedures stated. They represent best practice and we suggest you follow them where-ever possible. You are free to modify them and use other procedures if required.

We recommend that you use the same information in your RDMP in DashR.

Ordering scheduled drugs from MyLab

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For Schedule 2, 3 and 4 drugs, please follow the appropriate guide below. Type In orders for these drugs can be processed at the same time as Type In orders for high risk drugs.

High risk scheduled drugs: Schedule 4D, Schedule 8 and Schedule 9, require extra documents and approvals.

For an S4D, S8 or S9 order to be processed the Authority Holder/Responsible Drugs Overseer will need an entry in the High Risk Drug Databank, which provides High Risk Approvers and the MyLab team access to your:

• NSW Authority to Possess S8 or S9 drugs
• High Risk and Restricted Chemicals Risk Assessment & Approval (HIRAC) form
• Safe Work Procedure (SWP)
• Authorised user list

Refer to the scheduled drugs management intranet page for the steps to complete prior to placing an order and links to templates (e.g. HIRAC and SWP) and guides.

Ensure you have organised a drug register, secure storage and a restricted virtual space in MyLab for your high risk items prior to placing any orders. Drugs must be safely transported to their storage location when you collect your order.

Drugs that are acquired for zero cost must be