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GCP Standard Operating Procedures - Health Innovation, Investment and Research Office

 

Queensland Health GCP Standard Operating Procedures

Queensland Health, with the agreement of the Victoria Managed Insurance Agency (VMIA) has produced this set of Good Clinical Practice (GCP) based Standard Operating Procedures (SOPs) for use during the conduct of clinical research. These SOPs are intended to complement institutional and sponsor SOPs and should be used to guide clinical practice.

In instances where other regulatory SOPs compete with these, whichever SOPs offer the highest standards of safety and practice should be applied.

SOP 1  Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records 
Appendix 1 Template for Signature and Delegation Log (word doc) 
Appendix 2 Example Training Record Form (word doc)
 
SOP 2 The Study Site Master File and Essential Documents
 
SOP 3 Communication with HREC, Trial Sponsor and Insurer (Sponsored Clinical Trials Only) 
 
SOP 4 Protocol and Investigational Brochure Content, Design, Amendments & Compliance 
Appendix 1 ICH standard protocol template (word doc)
Appendix 2 ICH standard investigational brochure template (word doc)
 
SOP 5 Receipt and Handling of Investigational Product 
Appendix 1 Example IP accountability log (word doc)
 
SOP 6 Informed Consent Procedures and Writing Participant Informed Consent Forms 
 
SOP 7 Case Report Forms, Source Documents, Record Keeping and Archiving 
 
SOP 8 Site Initiation and Close Out (Sponsored Clinical Trials) 
 
SOP 9 TGA Notification and SAE Reporting Requirements 
 
SOP 10 Investigator Responsibilities 
 
SOP 11 Sponsor Responsibilities In Investigator Initiated Studies
 
SOP 12 Handling and Shipping of Biological Substances, Category B and/or Dangerous Good for Clinical Trials
 
SOP 13 Standard Operating Procedure (SOP) Creation, Implementation and Revision
Appendix 2 Standard SOP Template (word doc)
Appendix 3 Document review form (word doc)
Appendix 4 Document tracking form (word doc)

 

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Last updated: 21 July 2016