Clinical Trials Resources
Clinical Trial Standard Operating Procedures (SOPs)
- SOP 01 Standard Operating Procedure Creation, Implementation and Revision
- SOP 02 Investigator Responsibilities
- SOP 03 Site Staff Qualifications, Training Records
- SOP 04 Protocol and Investigational Brochure (IB) Requir
- SOP 05 Communication with Human Research Ethics Committe
- SOP 06 Site Initiation
- SOP 07 The Study Master File
- SOP 08 Case Report Forms and Source Documents
- SOP 09 Participant Informed Consent Process & Documenta
- SOP 10 Handling and Shipping of Biological Substances (Cat B) and Dangerous Goods
- SOP 11 Management of Investigational Product
- SOP 12 Safety Data Monitoring and Reporting Requirement
- SOP 13 Site Close Out and Archiving
- Standard Operating Procedure (SOP) Abbreviations and Terms
Consumer guide to clinical trials
Download the Australian Clinical Trials and Consumer Health Forum of Australia Consumer Guide to Clinical Trials Fact Sheet.
Australian Clinical Trial Handbook
Australian Charter of Healthcare Rights
The Australian Charter of Healthcare Rights describes what consumers, or someone they care for, can expect when receiving health care, this includes clinical trials. Learn more on their website.
Australian Charter of Healthcare Rights
Culturally and Linguistically Diverse Ethics Resources (CALDER)
This Melbourne Academic Centre for Health (MACH) has funded and developed videos in several languages to provide patients and their families with some key information about participating in clinical trial research:
- Clinical Trials and You (English)
- Clinical Trials and You (Italian)
- Clinical Trials and You (Vietnamese)
- Clinical Trials and You (Mandarin)
For more information about CALDER is available via Melbourne Academic Centre for Health.
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