Research Forms and Templates

Ethics Forms and Templates   (Governance forms below)

Checklist

• Ethics Submission Checklist -  REQUIRED for every submission

Payment form (required for externally sponsored clinical trials only)

• Method of Payment Form - for new submissions and amendments

Cover letter

• Cover letter - New submission

Protocol Templates

• Protocol Template - Non-Clinical Trials
• Protocol Template - Clinical Trials
• Alternate Protocol Template

PISCF and other participant document templates

• PISCF - Clinical Trials/Clinical Research
• PISCF - Research Involving Genetic Testing/Tissue Collection 
• PISCF - Low/Negligible risk (LNR) study
• NHMRC Standardised Participant Information Sheet and Consent Forms
• Participant Invitation Letter
• Participant Withdrawal Form
• Style Guide for Participant Information

Consumer involvement

• SESLHD Consumer Engagement Plan template

Governance Forms and Templates

Checklist (REQUIRED with every submission)

• Research Governance Checklist

Payment form (REQUIRED for externally sponsored clinical trials only)

• Method of Payment Form - for new submissions and amendments

Data Custodian Request (Required when SESLHD data is being transferred outside of the LHD)

• Template - Data Custodian Request
  • Guide to SESLHD Data Custodian request

Budget template

• SESLHD Research Project Budget Template

Access Request

• Access Request Form

Indemnity - Medicines Australia Forms 

• https://www.medicinesaustralia.com.au/policy/clinical-trials/indemnity-compensation-guidelines/

CTRAs / Medicines Australia Research Agreements

• Medicines Australia Clinical Research Agreement Templates
  • CTRA Guide - Guide to Medicines Australia Clinical Research Agreement Templates

Other agreements (not clinical trials)

• https://www.australianclinicaltrials.gov.au/resources/collaborative-research-agreement-template-projects-not-involving-clinical-trials

Other

• Significant Safety Issue (SSI) Notification Form 
• SUSAR/USADE/URSAE Notification Form
•  

All Research related SESLHD policies and guidelines can be located here.

The inclusion of links to external websites does not imply any endorsement or support by South Eastern Sydney Local Health District or Ministry of Health or the State of New South Wales. See our Disclaimer for more information.