Useful Links
Welcome to our Useful Links page. Here, you will find a curated selection of resources to assist you in your clinical research endeavors. Access participant information consent sheets, free GCP courses, NHMRC guidelines, the Clinical Trials Handbook, and more. These links are designed to provide you with the essential tools and information needed to support your work and ensure compliance with industry standards.
GCP courses (free and fee-applicable)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. It ensures the safety, rights, and well-being of trial participants, and the credibility of trial data. Compliance with GCP is essential for conducting reliable and ethical research.
Below are a few links of where you can find free and fee applicable GCP courses online.
NIDA Clinical Trials Network (Free)
The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.
NHMRC Guidelines
The NHMRC guidelines in Australia provide ethical and scientific standards for health and medical research. They ensure research integrity, safety, and quality, covering areas like human research ethics, clinical trials, and public health. These guidelines are crucial for maintaining ethical practices and high standards in Australian research.
Clinical Trials Handbook
The Clinical Trials Handbook in Australia offers comprehensive guidance on conducting clinical trials, covering regulatory requirements, ethical considerations, and best practices. It ensures trials are conducted safely, ethically, and in compliance with national standards, providing essential information for researchers and stakeholders in the clinical research field.
Australian Clinical Trial Handbook
This handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.
Participant Information Sheet/Consent Form (PISCF) Templates
In Australia, the participant information sheet and consent form, as per NHMRC guidelines, provide essential details about a clinical trial to potential participants. They ensure participants understand the study's purpose, procedures, risks, and benefits, enabling informed consent and safeguarding participants' rights and well-being in research.
Participant Information and Consent forms
Patient Information Consent Forms (PICFs) require Local Sponsors and any person or organisation, to whom a trial participant's personal information is transferred, to comply with Australian privacy laws, the Health Records Act 2001 (Vic) and where applicable the Victorian Privacy and Data Protection Act 2014 (Vic).