5. Investigator and Investigational Product

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 Requirement for ICF to be Administered as Audio/Visual

5.5 Requirement for Data Capture/Management (e.g., Privacy Regulations, etc.)

5.6 Home Healthcare Professional Visits (HHCP) Permission in Decentralized and/or Hybrid Studies

5.7 Regulations and Requirements around Direct to Patient (DTP) Study Product Delivery in Clinical Trials

5.8 Regulations and Requirements around Providing Products via Pharmacy/Amazon, etc.

5.9 Participant Compensation for Purchased Study Product or Prior to Product Acquisition for a Marketed Study Product/OTC & Its Impact on the Study

5.10 Participant Stipends

5.11 Specific Labeling Requirements for Clinical Study Product

5.12 Documents and Process to Import an Investigational/Study Product

5.13 Turn-around Time for Import Permit

5.14 Requirements and Regulations around the Destruction of Clinical Supplies at an Off-site Location After Study Completion