Act 2 · Understand
Feedback digest
What ethics committees, monitors and investigators said, grouped by theme. Every comment opens its source.
Sample values. Synthetic study, not real patients.
Method: keyword_lexicon_v1. Themes from a bilingual keyword lexicon; a person reviews each theme. A model-based themer will run behind the gateway once one is chosen.
Consent · Đồng ý tham gia
| Comment | From | Date | Source | |
|---|---|---|---|---|
| The consent form should explain secondary use of the data in plain language. | ethics committee | 2022-10-31 | ethics_letter_national.en.md#C-EN-02 | review |
| Đề nghị nghiên cứu viên cập nhật mẫu phiếu đồng ý tham gia cho phù hợp với phiên bản đề cương mới. | ethics committee | 2022-09-05 | ethics_letter_site.vi.md#C-ES-01 | review |
| Two participants signed an outdated consent version. | monitor | 2023-09-18 | monitoring_report_1.en.md#C-MR-03 | review |
Safety reporting · Báo cáo an toàn
| Comment | From | Date | Source | |
|---|---|---|---|---|
| Hypoglycaemia was rare and mild. | investigator | debrief_notes.en.md#C-DB-05 | review | |
| Hypoglycaemia monitoring and the stopping rule for safety should be described. | ethics committee | 2022-10-31 | ethics_letter_national.en.md#C-EN-03 | |
| Cần bổ sung quy trình báo cáo biến cố bất lợi nghiêm trọng trong vòng 24 giờ. | ethics committee | 2022-09-05 | ethics_letter_site.vi.md#C-ES-03 | review |
Visit schedule · Lịch thăm khám
| Comment | From | Date | Source | |
|---|---|---|---|---|
| Patients from rural districts missed interim visits during the harvest season. | investigator | debrief_notes.en.md#C-DB-03 | ||
| Lịch thăm khám dày đặc có thể gây khó khăn cho bệnh nhân ở xa; đề nghị xem xét cửa sổ thăm khám. | ethics committee | 2022-09-05 | ethics_letter_site.vi.md#C-ES-04 | |
| Several week 13 visits fell outside the visit window. | monitor | 2023-09-18 | monitoring_report_1.en.md#C-MR-02 | review |
Data entry and queries · Nhập liệu và truy vấn
| Comment | From | Date | Source | |
|---|---|---|---|---|
| Coordinators entered data in batches at the end of each month. | investigator | debrief_notes.en.md#C-DB-04 | review | |
| Data entry at S03 lags the visit by more than two weeks on average. | monitor | 2023-09-18 | monitoring_report_1.en.md#C-MR-01 | review |
| Open queries at S03 are not being closed within the agreed time. | monitor | 2023-09-18 | monitoring_report_1.en.md#C-MR-04 | review |
Recruitment · Tuyển chọn
| Comment | From | Date | Source | |
|---|---|---|---|---|
| Enrolment was slower than planned because many referred patients had HbA1c below the eligibility range. | investigator | debrief_notes.en.md#C-DB-01 | ||
| Please describe how participants will be recruited at the provincial site. | ethics committee | 2022-10-31 | ethics_letter_national.en.md#C-EN-04 | review |
| Screening at S03 is slower than planned; referral from district clinics is limited. | monitor | 2023-09-18 | monitoring_report_1.en.md#C-MR-05 |
Eligibility criteria · Tiêu chí lựa chọn
| Comment | From | Date | Source | |
|---|---|---|---|---|
| The HbA1c criterion excluded more patients than we expected. | investigator | debrief_notes.en.md#C-DB-02 | ||
| Tiêu chí loại trừ về chức năng thận (eGFR) cần nêu rõ ngưỡng và phương pháp đo. | ethics committee | 2022-09-05 | ethics_letter_site.vi.md#C-ES-02 |
Usual care and other medicine · Chăm sóc thường quy và thuốc khác
| Comment | From | Date | Source | |
|---|---|---|---|---|
| About a third of patients also used traditional medicine. | investigator | debrief_notes.en.md#C-DB-06 | review | |
| Nhiều bệnh nhân dùng thêm thuốc y học cổ truyền song song. | investigator | debrief_notes.en.md#C-DB-07 | review |
Sample size · Cỡ mẫu
| Comment | From | Date | Source | |
|---|---|---|---|---|
| The sample size justification should state the assumed standard deviation and its source. | ethics committee | 2022-10-31 | ethics_letter_national.en.md#C-EN-01 |