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Research resources

For more detailed information,  head to the Launching Pad

The Launching Pad enables you to access all documents on this page, and will also guide you through each of the major stages of a research project, connect you to the key supporting departments across Melbourne Children's Campus, and provide links to campus and national research regulations, guidelines and procedures.  

To enrol in CRDO workshops click here.

Trial Phase

Document name

Type

Release Date

Study Development

Feasibility Checklist

Template

 

Study Development

Risk assessment and management

Template

20/10/2020

Study Development

Study task timeline (abbreviated)

Template

17/01/2018

Trial Protocol

Developing, amending, and adhering to research protocols

Guidance

13/10/2017

Trial Protocol

Clinical Trial (not Drug/Device) Protocol, annotated

Template

09/02/2019

Trial Protocol

Clinical Trial (Drug/Device) Protocol, annotated

Template

29/11/2019

Trial Protocol

Observational study Protocol

Template

06/04/2019

Trial Protocol

Investigator’s Brochure Content, Design, Amendments, Filing & Distribution

SOP

10/10/2017

Contracts, Indemnities & CTNs

Request for MCTC eCTN Submission Form

Form

21/07/2020

Contracts, Indemnities & CTNs

Clinical Trial Contracts, Indemnities and CTN Process Map

Process Map

19/12/2017

Contracts, Indemnities & CTNs

Clinical Trial Registration of Investigator Initiated Trials (IITs) 

SOP

14/02/2020

Budgeting

Budget Guidance: Setting up a research budget

Guidance

11/10/2016

Budgeting

Budget template

Template

18/05/2016

Sponsorship Process

Institutional Sponsorship Application and Approval for
ponsor-Investigator Initiated Trials

SOP

13/01/2020

Sponsorship process

Sponsorship Application Form and Risk Matrix

Template

13/01/2020

Sponsorship Process

Certificate of Sponsorship and Investigator Responsibilities

Template

24/03/2020

Ethics and Governance

REG Approvals for STANDALONE SITES

Process Map

10/10/2017

Ethics and Governance

REG Approvals for ACCEPTING SITES

Process Map

10/11/2017

Essential Documents

Trial Master File (TMF) Filing

Guidance

22/12/2020

Essential Documents

TMF Table of Contents

Template

18/01/2021

Essential Documents

TMF paper binder section dividers

Template

18/01/2021

Essential Documents

Site Information File (SIF) Filing

Guidance

22/12/2020

Essential Documents

SIF Table of Contents

Template

18/01/2021

Essential Documents

SIF paper binder section dividers

Template

18/01/2021

Essential Documents

Investigator Site File (ISF) Filing

Guidance

22/12/2020

Essential Documents

ISF  T able of Contents

Template

18/01/2021

Essential Documents

ISF paper binder section dividers

Template

18/01/2021

Essential Documents

Documenting Trial Personnel Responsibilities, Qualifications and Training for
Investigator-Initiated Trials (IITs)

Guidance

19/08/2020

Staff Management

Wet Ink Signature Log

Template

17/11/2020

Staff Management

Signature Log & Delegation of Duties

Template

27/04/2020

Staff Management

Clinical trial Investigator - Short CV

Template

21/03/2017

Staff Management

Training Log

Template

30/03/2020

Staff Management

Key Personnel in IITs

Note

19/08/2020

Getting Started

Study Start Up for Clinical Trials

SOP

02/03/2020

Getting Started

Study Start Checklist

Template

23/01/2019

Getting Started

S ite Activation Letter

Template

05/01/2021

Information Management

Principles of the General Data Protection Regulation (GDPR) & Data Protection

in a Research Context: A Guideline for Researchers

Guidance

19/04/2021

Information Management

GDPR Cheat Sheet for Researchers 

Note

19/04/2021

Information Management

Data Protection Checklist

Checklist

19/04/2021

Information Management

Data collection for research: source documents and the Case Report Form (CRF)

Guidance

01/02/2012

Information Management

Note to File

Template

19/06/2020

Information Management

Copying and certifying essential documents

SOP

17/05/2018

Information Management

Sample Collection Handling and Transport

SOP

05/12/2018

Information Management

Setting up a document for Digital Signing

Note

19/08/2020

Information Management

Source Document Template

Template

26/03/2020

Data Sharing

Data sharing and access procedure for the release of data
from MCRI sponsored Investigator Initiated clinical trials

SOP

22/10/2020

Data Sharing

Data Access Application

Form

22/10/2020

Data Sharing

Transfer of Data

Form

22/10/2020

Data Sharing

Data Sharing Plan

Form

22/10/2020

Data Sharing

Data Request Review

Form

22/10/2020

Recruiting

Pre-screening Log (pre-consent)

Template

23/01/2019

Recruiting

Consent, Screening & Enrolment Log

Template

23/01/2019

Recruiting

Recruitment, screening, and enrolment of research participants

Guidance

03/07/2019

Safety Monitoring & Reporting

Safety Monitoring and Reporting Procedure for
MCRI-sponsored investigator-Initiated

Trials of Medicines/Medical Devices

SOP

03/07/2019

Safety Monitoring & Reporting

Site PI Safety Reporting (IIT)

Process Map

18/03/2020

Safety Monitoring & Reporting

Sponsor Safety Reporting (IIT)

Process Map

18/03/2020

Safety Monitoring & Reporting

Expedited Safety Report Form

Template

18/03/2020

Safety Monitoring & Reporting

Safety Reporting Timelines for IMPs

Timeline

19/03/2020

Safety Monitoring & Reporting

Safety Reporting Timelines for IMDs

Timeline

19/03/2020

Quality Assurance

Clinical Monitoring Plan

Template

05/01/2018

Quality Assurance

Data and Safety Monitoring Boards

Guidance

28/11/2018

Quality Assurance

DSMB Charter

Template

30/11/2018

Quality Assurance

DSMB Meeting Agenda

Template

30/11/2018

Quality Assurance

DSMB Open Report

Template

30/11/2018

Quality Assurance

Continuous improvement: a corrective and preventive action (CAPA) plan

SOP

03/07/2019

Quality Assurance

CAPA  Plan 

Template

07/03/2019

Quality Assurance

CAPA  Tracking Log

Template

07/03/2019

Quality Assurance

Monitoring Visit Activities

SOP

05/01/2018

Quality Assurance

Monitoring visit report

Template

19/03/2020

Quality Assurance

Participant Level Monitoring Form

Template

08/11/2018

Quality Assurance

SOP creation, implementation, and revision

SOP

13/07/2017

Quality Assurance

Trial Steering Committee Charter

Template

22/09/2020

Study Closure

Study Closure checklist

Template

20/03/2017