Guidelines

Submissions Guidelines
Amendments Guide
Guidelines for Clinical Drugs Trials at SCGH
Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Trial

Forms

Application Form – Section 1
Application Form – Section 2a
Application Form – Section 2b
Covenant of Confidentiality
Indemnity Form
Medicines Australia Form of Indemnity for Clinical Trials
Site Authorisation Form
Annual Report Form

Clinical Trial Agreement Forms

Templates

Genetics PICF Template
PICF Guide & Template

Other

Meeting and Submission Schedule 2010
Next of Kin Research
Quality Improvement versus Research
Sample and Power Sizes
Low Risk Review Criteria

Serious Adverse Event Reporting

NHMRC Australian Health Ethics Committee (AHEC) Position Statement
SAE Cover Sheet
SAEs Alert