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Document Templates

​​​​​​​​​​​​​​​​​​​​​​​​​​​The following document templates and legal agreements are available for use in a research project. They should be completed externally and then uploaded into the RGS and submitted with your application as a  supporting document​

Monitoring Forms cannot currently be submitted via RGS but are located at the following ethics​ and governance links.

Investigator Response Letter Templates

  1. Investigator Response Letter to an Ethics Committee
  2. Investigator Response Letter to a Research Governance Office​​.

Research Protocol Templates 
  1. WA Health Research Protocol Template for Clinical Trials
  2. WA Health Research Protocol Template for Non-Clinical Trials​​.
 

Participant Information & Consent Forms (PICF)
  1. National Health and Medical research Council PICF templates
  2. WA Health Standard PICF template​.

 

Student Research and Confidentiality Declaration
  1. WA Health Student Research and Confidentiality Declaration
 

​Confidentiality ​Disclosure Agreement

  1. WA Health Confidentiality Disclosure Agreement​​​

Clinical Trial and Clinical Investigation Research Agreements
  1. WA Health - MA Clinical Trial Research Agreement – Standard (Form A)
  2. WA Health - MA Clinical Trial Research Agreement – Collaborative or Cooperative Research Group (CRG) Studies (Form C)
  3. WA Health - MA Clinical Trial Research Agreement – Contract Research Organisation acting as Local Sponsor (Form D)
  4. WA Health - MA Clinical Trial Research Agreement – Phase IV Clinical Trial (Form E)
  5. WA Health - MA Clinical Trial Research Agreement - Phase IV Clinical Trial Contract Research Organisation acting as Local Sponsor (Form F)
  6. WA Health - MTAA Clinical In​vestigation Research Agreement - Standard (CIRA)

Note: The documents download quicker using Chrome.

    ​

Research Agreements   
  1. Material Transfer Agreement (Word 72KB)
  2. Funding Agreement (Word 108KB)
  3. Service Agreement – WA Health providing the service (Word 91KB)
  4. Service Agreement – WA Health receivi​ng the service (Word 79KB)
      

​ ​Indemnity Forms   
  1. Medicines Australia Standard Form of Indemnity for Clinical Trials 
  2. Medicines Australia HREC Review Only Form of Indemnity for Clinical Trials
  3. Medicines Australia Compensation Guidelines for Clinical Trials
  4. Medical Technology Association of Australia Standard Indemnity Form for a Clinical Investigation


More Information

Investigator Response Letter Templates

These templates are provided for use by investigators who are required to provide additional information, to either an ethics committee (subcommittee or Human Research Ethics Committee) or a Research Governance Office, regarding a research project application. They can be uploaded in the RGS as  a supporting document when re-submitting forms or documents.


WA Health Research Protocol Templates

These templates are provided as a guide for investig​ators who do not already have a protocol for their research project. It is a requirement of WA Health that a pr​otocol is submitted with the ethics application.

These templates are based on the Therapeutic Goods Administration Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) 2000 and the World Health Organisation Recommended format for a Research Protocol. To meet Good Clinical Practice Guidelines the Protocol should contain, but not be restricted to, the information contained within these templates.​​


 

Participant Information Consent Forms (PICFs)

WA Health investigators are encouraged to utilise the National Health and Medical Research Council's standard PICFs. These documents provide guidance in the formulation of consent forms for both single-centre and multi-centre research projects.

The templates should be used as a minimum starting point prior to the ​addition of jurisdictional and project specific information. Sections that are not applicable to the research project may be removed.

The 12 forms include three participant categories as identified by the National Statement:

  • Individual participant
  • Child participant
  • Participants unable to provide consent.  Read the requirement on the WA Specific Module on WA Legislation regarding consent.
Within each category of participant, three specific research type templates are available:
  • Genetic Studies
  • Health and Social Science Studies
  • Interventional Studies
  • Non-Interventional Studies. ​

 

Declaration

External research personnel who will be either conducting a research project within WA Health or accessing WA Health participants, their tissue or data for a research project will have to complete one or both of the following confidentiality declarations:

  • The WA Health Declaration of Confidentiality must be completed in the RGS by all research personnel who are non-WA Health employees accessing a project. This includes research personnel with joint appointments, when the WA Health employee is conducting a project in their non-WA Health employee capacity.

  • The Student Research and Confidentiality Declaration must be completed by all student research personnel (irrespective of whether they are WA Health employees).  In the RGS the Student Research and Confidentiality Declaration should be attached as a supporting document to the governance application.
 

Confidentiality Disclosure Agreement

WA Health has established a standard Confidentiality Disclosure Agreement (CDA) which is recommended for use in clinical trial research and data registries, which can be negotiated with the external party in line with WA Government legal and legislative policy and guidelines.​


 

Clinical Trial and Clinical Investigation Research Agreements

A standard, system-wide approach to the agreements and indemnities applying to research projects conducted in WA Health is in place. For further information regarding the governance of research projects within WA Health refer to the WA Health Research Governance Framework.

Consistent with other jurisdictions, WA Health uses the Medicines Australia (MA) and Medical Technology Association of Australia (MTAA) template agreements.  Each of these agreements provides for amendments to be made to the terms presented in the body of the agreement. WA Health has specified a number of amendments to be included in the relevant schedule to the agreement, in line with WA Government legal and legislative policy and guidelines.​ These agreements were updated in March - May 2017.


 

Research Agreements

A standard, system-wide approach to the agreements and indemnities applying to research projects conducted in WA Health is in place. For further information regarding the governance of research projects within WA Health refer to the WA Health Research Governance Framework. WA Health has research agreements available for research projects not involving clinical trials, clinical investigations or registries.​


 

Indemnity Forms

For commercial clinical trials, sponsors (or the contract research organisation) are required to provide the relevant Medicines Australia Form of Indemnity for Clinical Trials. These forms reference the 'Guidelines for Compensation for Injury Resulting From Participation in a Company-sponsored Clinical Trial' which the sponsor agrees to adhere to if injury is suffered by a participant while participating in the Study (project). Investigators must make it clear to the participants that the project is being conducted subject to those Guidelines.

For commercial clinical investigations, sponsors (or the contract research organisation) are required to provide the relevant Medical Technology Association of Australia Standard Indemnity Form for a Clinical Investigation.​​


 

         

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