| Id |
Subject |
Object |
Predicate |
Lexical cue |
| T39 |
0-46 |
Sentence |
denotes |
Alternatives to on‐site regulatory inspections |
| T40 |
47-175 |
Sentence |
denotes |
The idea of a virtual regulatory inspection seemed reserved for the next generation of regulatory professionals, until COVID‐19. |
| T41 |
176-333 |
Sentence |
denotes |
Our experience with remote Good Clinical Practice and pharmacovigilance inspections by regulators during the pandemic has been both positive and encouraging. |
| T42 |
334-474 |
Sentence |
denotes |
The challenges of COVID‐19 underscore the importance of achieving process efficiency while at the same time ensuring high‐quality standards. |
| T43 |
475-681 |
Sentence |
denotes |
To date, the remote inspections have demonstrated efficiencies for regulators and sponsors by eliminating travel, enhancing document management systems, and fostering disciplined and focused communications. |
| T44 |
682-1013 |
Sentence |
denotes |
We recognize the broader practice of virtual inspections is untested, but it’s an area worth exploring, where regulatory inspections of investigator sites and sponsors are digitally enabled (e.g., secure video conferencing), allowing inspectors to interview personnel, review procedures, and validate data against source documents. |
