Research process resources: Management
“Important note: All documents can be found on the METIS Database. You can search using the document code or key words in title.”
Study record management and essential documents
Clinical Research Development Office (CRDO) resources
Filing guidance
Trial Master File (TMF)
The collection of essential documents used by the Sponsor-Investigator/CPI for the management of the trial.
Guidance | Trial Master File (TMF) filing (PDF)
Trial Master File (TMF) Table of Contents (downloadable word doc)- Trial Master File (TMF) paper binder section dividers (downloadable word doc)
Site Information File (SIF)
A subsection of the TMF contains duplicates of site-specific essential documents required for the management of the trial. These are also held in the Investigator Site File (ISF) for and by the Principal Investigator.
- Guidance | Site Information File (SIF) filing (PDF)
- Site Information File (SIF) Table of Contents (downloadable word doc)
- Site Information File (SIF) paper binder section dividers (downloadable word doc)
Investigator Site File (ISF)
The collection of essential documents used by the Principal Investigator for the management of the trial at the site.
- Guidance | Investigator Site File (ISF) filing (PDF)
- Investigator Site File (ISF) Table of Contents (downloadable word doc)
- Investigator Site File (ISF) paper binder section dividers (downloadable word doc)
The filing structures detailed in these guidance documents are available on request. Please email
show email address to request these.
Please note: Storing the TMF, SIF and/or ISF on a computer drive is not GDPR or GCP compliant, and is not appropriate for Clinical Trials.
Florence eBinders
CRDO recommends using Florence eBinders, a fully validated FDA 21 CFR Part 11, HIPAA, ICH-GCP and GDPR-compliant service. The system has audit trails, is backed up 3 times a day, and is a validated and compliance-tested program.
Florence eBinders also offers a range of project management tools. The electronic format allows for forwarding correspondence directly into eBinders via email, eSignatures, redacting/de-identifying and annotating source documents, and setting expiration dates on documents to improve efficiency and reduce duplication. Customisable Roles and Permissions allow for greater oversight of document management.
- Florence eBinders
- Compare Florence eBinders to other document solutions (PDF)
- Workflow | eLog Management and Troubleshooting (PDF)
- Workflow | Emails in Florence (PDF)
Please submit the eBinders request form (external link) to sign your trial up to Florence.
Other filing resources
- Standard Operating Procedure (SOP) |Document Management and Version Control (PDF)
- Guidance | Electronic File Naming Conventions (PDF)
- Guidance | Copying and Certifying Essential Documents (PDF)
- Template | Note to file (downloadable word doc)
All international clinical trials sponsored by MCRI must use Florence eBinders to ensure that they are fully 21 CFR Part 11 and GDPR compliant.
Melbourne Children’s resources
- Murdoch Children's Archiving Service Desk (Internal staff only)
- Policy | The Royal Children's Hospital | Research Documents and Records
Privacy and data protection
Clinical Research Development Office (CRDO) resources
- Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context: A Guideline for Researchers (PDF)
- Cheat sheet for Researchers | General Data Protection Regulation (GDPR) (PDF)
- Checklist | Data protection (downloadable word doc)
External resources
Study management
The templates below provide an abbreviated guide to the tasks involved in setting up, conducting and completing a study.
Clinical Research Development Office (CRDO) resources
Standard Operating Procedure (SOP)
- SOP | Study start-up for clinical trials (PDF)
- Checklist | Study feasibility (downloadable word doc)
Timeline | Study Tasks (downloadable excel document) - Template | Study start-up checklist (downloadable word doc)
- Template | Site Activation Letter (downloadable word doc)
- SOP | Site Initiation (PDF)
- Summary | Site Initiation (PDF)
- Template | Site Initiating Booking Letter (downloadable word doc)
- Template | Site Initiation Agenda (downloadable word doc)
- Template | Site Initiation Attendance Log (downloadable word doc)
- Template | Essential Document Request Letter (downloadable word doc)
- Template | Site Initiation Follow-Up Letter (downloadable word doc)
- Template | Site Initiation Follow-Up Report (downloadable word doc)
- SOP | Regulatory Green Light Approval for Clinical Trial Site Activation (PDF)
- Template | Regulatory Green Light Approval form (downloadable word doc)
- Guidance | Creation of New Standard Operating Procedures (PDF)
- Checklist | Study closure (downloadable word doc)
- Workshop | Good Clinical Practice (GCP) in Research
Melbourne Children's resources
- Research Integrity (internal staff only)
Other resources
- Australian Code for the Responsible Conduct of Research and its supporting guidance documents
- National/International Guidance and Policies
Study team management
All members of the study team must be appropriately trained and qualified to perform the research procedures they undertake. The Principal Investigator must document the tasks they delegate to study team members. Keeping records of the team and their activities is essential for evaluating the conduct of the study.
Clinical Research Development Office (CRDO) resources
- Documenting Trial Personnel Responsibilities, Qualifications and Training for Investigator-Initiated Trials (IITs) (downloadable word doc)
- Template | Study team training log (downloadable word doc)
- Guidance & template | Delegation & Signature Log (downloadable word doc)
- Template | Investigator short CV (Clinical Trials) (downloadable word doc)
- Template | Wet Ink Signature Log (downloadable word doc)
Melbourne Children’s resources
- Policy | Murdoch Children's Human Resources (internal staff only)
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