Clinical Trials Resources
Clinical Trial Standard Operating Procedures (SOPs)
- SOP – Abbreviations and Terms v3.0 SOP 01 Standard Operating Procedure Creation, Implementa v3.1
- SOP 02 Investigator Responsibilitie v3.0
- SOP 03 Site Staff Qualifications, Training Records and v3.1
- SOP 04 Protocol and Investigational Brochure (IB) Requir v3.0
- SOP 05 Communication with Human Research Ethics Committe v3.0
- SOP 06 Site Initiation v3.0
- SOP 07 The Study Master File v3.1
- SOP 08 Case Report Forms and Source Documents v3.0
- SOP 09 Participant Informed Consent Process & Documenta v3.0
- SOP 10 Handling and Shipping of Biological Substances v3.0
- SOP 11 Management of Investigational Product v3.0
- SOP 12 Safety Data Monitoring and Reporting Requirement v3.0
- SOP 13 Site Close Out and Archiving v3.0
- Clinical Trial Standard Operating Procedure 14 Hosting a Regulatory Inspection, Sponsor or HREC v1.0
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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