2. General Questions

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 submission

2.6 Import Permit/License Requirement before Investigational Product/Study Product is Shipped

2.8 Permission for Clinical Studies of GMOs

2.9 In-country Sponsor Presence Requirement

2.10 Local PI Requirement

2.11 Local Chief or Coordinating Investigator

2.12 Requirement for Authorization or Transfer of Obligations from the Sponsor

2.13 Registering Clinical Trials on a Local Registry or Database

2.14 Local Requirement on Clinical Study Documents Archival (Timelines & Format)

2.15 Requirements for Periodic Safety Reporting and Timelines

2.16 Requirements for Periodic Clinical Study Updates, Specific Templates, & their Frequency

2.17 Country Regulations for Decentralized Clinical Trial (DCT) Model

2.18 Presence of Fully Virtual DCTs in the Country

2.19 Non-regulatory DCT Initiatives in the Country

2.20 Notification Requirements on “Serious Breaches”

2.21 Insurance and Indemnity Coverage