DEMO | Europe (EMA)

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 info...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in the EU/EEA in relation to Decentralized Clinical Trials (“DCT”)  through the  European Medicines Agency (“EMA”) and the Clinical Trials ...

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 E...

3.1 Documents Needed for EC/IRB Review and Approval 3.2 Turn-around Time for EC/IRB Review and Approval Process 3.3 Availability of Fast-track or Expedited Review Process 3.4 Requirement for Registration and/or Accreditation/Approval by R...

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 Investigator...

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 Local Requi...

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 7.6 HHC – Ho...

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 but i...

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

10.1 Roadmap of Clinical Trial with Investigational Medicinal Product 10.2 Road map of Clinical trial with Paediatric Investigation Plan 10.3 Clinical Study (Interventional or Observational)