Download Research Collaboration Agreement

Quick Reference Table
Key points
Agreements should be established for commercially sponsored research, research with collective or
collaborative groups and research involving collaboration between institutions (locally and
internationally).
There may also be a need for an indemnity statement and insurance certificate. Guidelines exist for
research agreements and research indemnity and insurance. The quick reference table outlines the
agreement, indemnity and insurance arrangements by type of research.
Pharmaceutical templates and compensation guidelines are issued by Medicines Australia.
Device templates and compensation guidelines are issued by MTAA.
Research involving a device, medicine or biological not listed on the Therapeutic Goods
Administration's ARTG (i.e. an "unapproved therapeutic good") or an approved device, medicine or
biological but used outside of its marketing approval, requires a clinical trials notification (CTN).
The name of the parties should be consistent across all documents, for example, the name of the
local commercial sponsor should be the same on the CTN, agreement, indemnity and insurance.
All legal and regulatory documents are to be submitted to the Office of Ethics and Research
Governance for signing. Researchers cannot sign on behalf of Alfred Health.
Clinical Trial Preparation Agreement ("Pre-Nup")
This can be used to cover the start-up fee and should be signed before or during the ethics review,
before the main agreement is executed.
Research Agreements
(Number of original required = minimum 2; 1 for each party)
Medicines Australia Standard Form (Commercially Sponsored Pharmaceutical Studies)
CTRA - Medicines Australia Standard Form
Medical Technology Association of Australia Standard Form (Commercially Sponsored Device
Studies)
Clinical Investigation Research Agreement (CIRA)
Medicines Australia CTRA: Contract Research Organisations (CROs) acting as the Local Sponsor
CTRA - Contract Research Organisation acting as the Local Sponsor
Medicines Australia Collaborative or Co-operative Research Group (CRG) Studies
CTRA - Collaborative or Cooperative Research Group (CRG) Studies
Medicines Australia Phase IV Clinical Trials (Medicines)
CTRA - Phase IV Clinical Trials (Medicines)
Investigator-Initiated clinical trial (suitable for multi-site studies)
VMIA template
Alfred Health Investigator-Initiated, Company Supported Studies
CTRA for investigator initiated studies - Alfred Health
Research Collaboration Agreement (suitable for non-clinical trials)
Research Collaboration Agreement template - Alfred Health
Material Transfer Agreements (MTA)
(Number of originals required = 2)
A MTA governs the exchange of materials between two organisations, usually for research purposes
and should be used for the transfer of tissue and other material. There are two types of MTAs:
incoming and outgoing. An outgoing MTA is used when Alfred Health is providing materials to an
external organisation.
Alfred Health Materials Transfer Agreement - outgoing
An incoming MTA is provided by the relevant institution to an Alfred Health researcher requesting
materials from an external source.
Standard form of indemnity for clinical trials
(Number of originals required = 2)
Medicines Australia Standard form of Indemnity for Pharmaceutical Trials
MTAA Standard Indemnity Form for a Clinical Device Investigation
HREC review only Indemnity
(Number of original required = 2)
Medicines Australia HREC review only Indemnity for Pharmaceutical Trials
MTAA Standard Indemnity Form for a Clinical Investigation HREC Review Only
Injury compensation guidelines
(as referenced in participant information and consent forms)
Medicines Australia - Guidelines for Compensation
MTAA Compensation Guidelines
Checklists for agreements and indemnities
Checklists have been developed for researchers to check the agreement and indemnity, if applicable,
before they are submitted to the Office of Ethics and Research Governance. If the checklist highlights
any of the details as incorrect, please arrange corrections prior to submission of the documents.
Checklist for non-investigator-initiated trials
Checklist for research collaboration agreement
Checklist for amendments or addenda
Clinical Trial Notification (CTN) Scheme Form
Information for researchers
CTN details form (for Alfred Health investigator initiated studies)
Alfred Health and Alfred Hospital Ethics Committee CTN details (can be provided to external sponsor)
CTN Additional Site Details Form (for collecting site details for an Alfred Health investigator initiated
study)
CTN payment
Amendments or Addenda to Agreements
(Number of originals required = minimum 2; 1 for each party)
Once the Agreement has been signed, any revisions to the Agreement are done via Amendment or
Addendum to the Agreement. Many Sponsors have their own template. Alfred Health has created a
template which can be used if the Sponsor does not have a template.
Alfred Health Amendment to Agreement for Commercially Sponsored Studies
Alfred Health Amendment to Agreement for Investigator-Initiated Studies
Alfred Health Amendment to Agreement for Research Collaboration Agreement
This page was last modified on 9/03/2016