DEMO | Australia

RegAsk has designed DCT Guidebooks for 27 territorie s ; which provide vital and validated current information on the regulatory framework around the Clinical Trial applications with a deep dive into DCT elements and their nuances. The in...

This workbook provides an overview of the current and proposed regulatory landscape applicable in Australia in relation to Decentralized Clinical Trials (“DCTs”). Australia abides by the regulations set forth by the Therapeutic Goods Administra...

2.1 Name of Regulatory Authority 2.2 Name of Ethics Committee (EC/REC/HEC/IRB) 2.3 Clinical Trial Application Language 2.4 Regulatory Approval for Regulatory Authorities and/or EC 2.5 Simultaneous Regulatory Authority and EC ...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. Applications to the HREC should be made electronically via the attached link: https://hrea.go...

4.1 Documents and Format Required for RA/CA Review and Approval 4.2 Timeline for RA/CA Review and Approval Process 4.3 Permission for Electronic Submission 4.4 Requirement for Applicant to be Principal Investigator (PI)/Chief In...

5.1 PI/CI Approval/Registration by Regulatory Authority as per Local Regulation 5.2 Documents Required if PI/CI is based Outside the Trial Country 5.3 Electronic ICF Administration Including Electronic Signatures Allowance 5.4 L...

6.1 Documents Needed for Export Permit of Biological Specimen Shipment 6.2 Requirement for Separate Consent for Biological Specimen Collection, Storage, and Future Research 6.3 Documents Needed for Biological Specimen Customs Clearance...

7.1 eConsent/Remote Consent  7.2 eSignature (Including Any Requirement for a Countersignature (e.g., of PI, Witness, etc.) 7.3 Remote Assessment 7.4 Electronic Patient Reported Outcome (ePro) 7.5 HHC – Home Nursing ...

8.1 Data Privacy and/or Technology Regulations in the Country of Trial 8.2 Data Locality Rules within each Jurisdiction 8.3 Verification and Validation Requirements of the CRO System (i.e., a software platform that runs clinical trials...

9.1 Governing Regulation Around Digital Advertisements (Including on Social Media) for Clinical Trial Subject Recruitment 9.2 Vulnerable Subjects 9.3 Pediatrics Subjects & Consent Regulation   9.4 Financial Disclosures&nbs...

10.1 Roadmap of Clinical Trial with Investigational Medicinal Product 10.2 Roadmap of Clinical Trial with Pediatric Investigation Plan 10.3 Clinical Study (Interventional or Observational)