Table 4.
Ranking of themes based on primary focus (N = 572 inquiries)
| Rank | Primary focus theme | # Inquiries | Percentage (%) |
|---|---|---|---|
| #1 | COVID-19-related study/research/treatment proposals | 120 | 21 |
| #2 | Informed Consent process/content/documentation | 47 | 8 |
| #3 | Electronic signature/record/system compliance | 47 | 8 |
| #4 | Remote data monitoring/wearables/mobile data health handling | 46 | 8 |
| #5 | Informing/interacting with FDA | 45 | 8 |
| #6 | Study eligibility/screening procedures/COVID-19 study participation | 38 | 7 |
| #7 | IP distribution/supply/suspension | 34 | 6 |
| #8 | Study/protocol amendment/change/deviation handling | 27 | 5 |
| #9 | IRB/IEC organization/operation | 21 | 4 |
| #10 | New/alternative clinical site/investigator | 20 | 4 |
| #11 | Issuance of COVID-19-related regulatory guidelines/resources | 20 | 4 |
| #12 | AE handling /safety reporting | 19 | 3 |
| #13 | Study delay/suspension/premature termination/resumption after pause | 18 | 3 |
| #14 | Study design/regulatory approval and process including digital tools | 16 | 3 |
| #15 | Virtual site visits/telehealth | 16 | 3 |
| #16 | Clinical data/statistical analysis /end of study database lock | 10 | 2 |
| #17 | FDA inspection during pandemic | 8 | 1 |
| #18 | cGMP/labelling compliance | 7 | 1 |
| #19 | Altered efficacy endpoint/primary outcome assessment | 5 | 1 |
| #20 | Bioequivalence/bioavailability assessment | 4 | 1 |
| #21 | Human specimen handling | 3 | 1 |
| #22 | User fee review activities | 1 | 0.2 |