Act 1 · Ingest

Study package

What was received, what was read, what is missing.

Sample values. Synthetic study, not real patients.

What this study can teach

Counts of profile values by layer and by source label, after the hospital's export was imported.

21 of 39 data-request items found. Missing and needed (Must): Ministry correspondence, Usual-care description.

Layer	Values by source	For example
Patient	Learned 7	Tablets taken as prescribed; Monthly dropout rate, all sites; Monthly dropout rate, central hospitals; Monthly dropout rate, provincial hospitals …
Investigator and site	Learned 17	Days from visit to data entry, all sites; Days from visit to data entry, central hospitals; Days from visit to data entry, provincial hospitals; Protocol deviations per patient-month, all sites …
Clinical practice	Elicited 1	Patients also using traditional medicine
System	Elicited 1	Days for approval and ethics
Design lessons	Learned 2	Observed difference in change in HbA1c from baseline to week 52 change; SD of change in HbA1c from baseline to week 52 change

Package checklist against the data request

Item	What	Need	Status	Where
1	Protocol, all versions Đề cương, mọi phiên bản	Must	found	protocol_v2.en.docx, protocol_v2.en.md, protocol_v2.en.pdf, protocol_v2.vi.docx, protocol_v2.vi.md
2	Protocol amendments Sửa đổi đề cương	Must	found	protocol_amendment_1.en.md
3	Statistical analysis plan Kế hoạch phân tích thống kê	Must	found	sap.en.md
4	Case report forms Phiếu thu thập dữ liệu	Must	found	crf_visit.en.md
5	Data dictionary Từ điển dữ liệu	Must	found	data_dictionary.csv
6	Consent forms, all versions Phiếu đồng ý, mọi phiên bản	Must	found	consent_form.vi.md
7	Intervention description Mô tả can thiệp	Should	missing
8	Final report and publications Báo cáo tổng kết và bài báo	Must	found	final_report.en.md
9	Screening data Dữ liệu sàng lọc	Must	found	held in the hospital zone
10	Baseline data Dữ liệu ban đầu	Must	found	held in the hospital zone
11	Visit-level outcomes Kết quả theo lần thăm khám	Must	found	held in the hospital zone
12	Treatment and dosing records Hồ sơ điều trị và liều dùng	Must	found	held in the hospital zone
13	Concomitant medication Thuốc dùng kèm	Should	missing
14	Adverse events Biến cố bất lợi	Should	missing
15	Withdrawals and losses Rút khỏi nghiên cứu và mất dấu	Must	found	held in the hospital zone
16	Genomic data Dữ liệu hệ gen	Should	missing
17	Site and investigator codes Mã cơ sở và nghiên cứu viên	Must	found	held in the hospital zone
18	Site list and activation dates Danh sách cơ sở và ngày kích hoạt	Must	found	held in the hospital zone
19	Enrolment log Sổ tuyển chọn	Must	found	held in the hospital zone
20	Recruitment sources Nguồn tuyển chọn	Should	missing
21	Consent refusals Từ chối tham gia	Should	missing
22	Protocol deviation log Sổ sai lệch đề cương	Must	found	held in the hospital zone
23	Data query log Sổ truy vấn dữ liệu	Should	found	held in the hospital zone
24	Data-entry timestamps Thời điểm nhập dữ liệu	Should	found	held in the hospital zone
25	Monitoring visit reports Báo cáo giám sát	Should	found	monitoring_report_1.en.md
26	Audit or inspection findings Kết quả thanh tra, kiểm tra	Nice	missing
27	Study staff and turnover Nhân sự nghiên cứu và biến động	Nice	missing
28	Budget and actual cost Ngân sách và chi phí thực tế	Should	missing
29	Ethics submissions and letters Hồ sơ và thư của hội đồng đạo đức	Must	found	ethics_letter_national.en.md, ethics_letter_site.vi.md
30	Ministry correspondence Thư từ với Bộ Y tế	Must	missing
31	Import, contract and other permits Giấy phép nhập khẩu, hợp đồng và khác	Should	missing
32	Safety committee records Hồ sơ hội đồng an toàn	Nice	missing
33	Investigator debrief Phỏng vấn nghiên cứu viên	Must	found	debrief_elicitation.json, debrief_notes.en.md
34	Coordinator and nurse debrief Phỏng vấn điều phối viên và điều dưỡng	Should	missing
35	Participant feedback Phản hồi của người tham gia	Nice	missing
36	Lessons-learned notes Ghi chép bài học kinh nghiệm	Should	missing
37	Usual-care description Mô tả chăm sóc thường quy	Must	missing
38	Clinic volumes Lượng bệnh nhân khám	Should	missing
39	Hospital record extract Trích xuất hồ sơ bệnh viện	Nice	missing

Data quality, from the hospital zone

Counted inside the hospital and exported as cells; below ten shows as <10. Estimates leave these rows out, or place an undated visit on its planned date, and say so.

Check	Count
Attended visits	1,500
Attended visits recorded without a date	26
Data entered before the visit it records	16
Visits never entered	0
Participants without a baseline value	0

Protocol as structured data

Every field links to the passage it came from. The English and Vietnamese versions are compared; a disagreement sends the field to review.

Field	Value	Source passage	Link	Status
title	A randomised, controlled trial of Study Drug X 10 mg once daily plus metformin against placebo once daily plus metformin in adults with type 2 diabetes in Vietnam	Title: A randomised, controlled trial of Study Drug X 10 mg once daily plus metformin against placebo once daily plus metformin in adults with type 2 diabetes in Vietnam.	protocol_v2.en.docx#para-4	rule match
arms	A: Study Drug X 10 mg once daily plus metformin B: Placebo once daily plus metformin	Arm A: Study Drug X 10 mg once daily plus metformin.	protocol_v2.en.docx#para-6	rule match
criteria	C1: HbA1c between 7.5% and 10.5% at screening C2: eGFR below 45 mL/min/1.73 m² C3: Written informed consent C4: Other conditions listed in Appendix 2	Inclusion C1: HbA1c between 7.5% and 10.5% at screening.	protocol_v2.en.docx#para-9	rule match
primary endpoint	change in HbA1c from baseline to week 52	Primary endpoint: change in HbA1c from baseline to week 52.	protocol_v2.en.docx#para-14	rule match
visit weeks	[0, 4, 13, 26, 39, 52]	Visits are scheduled at weeks 0, 4, 13, 26, 39 and 52, with a window of 7 days either side.	protocol_v2.en.docx#para-16	rule match
visit window days	7 days (as stated) Assumed	Visits are scheduled at weeks 0, 4, 13, 26, 39 and 52, with a window of 7 days either side.	protocol_v2.en.docx#para-16	rule match
planned sample size	300 (as stated) Assumed	The study will enrol 300 participants, 150 per arm, at 3 sites.	protocol_v2.en.docx#para-18	rule match
planned per arm	150 (as stated) Assumed	The study will enrol 300 participants, 150 per arm, at 3 sites.	protocol_v2.en.docx#para-18	rule match
planned sites	3 (as stated) Assumed	The study will enrol 300 participants, 150 per arm, at 3 sites.	protocol_v2.en.docx#para-18	rule match
assumed sd	1.00 % HbA1c (as stated) Assumed	Assumed standard deviation of HbA1c change: 1.0 percentage points.	protocol_v2.en.docx#para-19	rule match
assumed effect	−0.40 % HbA1c (as stated) Assumed	Assumed treatment difference: -0.4 percentage points.	protocol_v2.en.docx#para-20	rule match
alpha	5.0% (as stated) Assumed	Two-sided significance level 0.05 and power 90%.	protocol_v2.en.docx#para-21	rule match
power	90.0% (as stated) Assumed	Two-sided significance level 0.05 and power 90%.	protocol_v2.en.docx#para-21	rule match
planned dropout	10.0% (as stated) Assumed	Expected dropout: 10%. Expected screen failure: 25%.	protocol_v2.en.docx#para-22	rule match
planned screen failure	25.0% (as stated) Assumed	Expected dropout: 10%. Expected screen failure: 25%.	protocol_v2.en.docx#para-22	rule match
planned enrolment months	12 (as stated) Assumed	Enrolment is planned to last 12 months, and the whole study 24 months.	protocol_v2.en.docx#para-24	rule match
planned study months	24 (as stated) Assumed	Enrolment is planned to last 12 months, and the whole study 24 months.	protocol_v2.en.docx#para-24	rule match

De-identification

Direct identifiers removed inside the hospital zone; participant ids replaced with keyed pseudonyms. Free-text columns excluded because no local language model is configured: note.

Files received in the platform zone

Patient-level files never reach this zone. Their presence is reported by the hospital zone.

File	Type	Language	Typed by
consent_form.vi.md	consent form	vi	file name
crf_visit.en.md	case report form	en	file name
data_dictionary.csv	data dictionary	vi	file name
data_use_terms.json	unrecognised	en
debrief_elicitation.json	debrief form	en	file name
debrief_notes.en.md	debrief notes	en	file name
ethics_letter_national.en.md	ethics letter	en	file name
ethics_letter_site.vi.md	ethics letter	vi	file name
final_report.en.md	final report	en	file name
monitoring_report_1.en.md	monitoring report	en	file name
protocol_amendment_1.en.md	protocol amendment	en	file name
protocol_v2.en.docx	protocol	en	file name
protocol_v2.en.md	protocol	en	file name
protocol_v2.en.pdf	protocol	en	file name
protocol_v2.vi.docx	protocol	vi	file name
protocol_v2.vi.md	protocol	vi	file name
sap.en.md	analysis plan	en	file name