MainEDC export

What the MainEDC export looks like, how it is read and what is checked.

MainEDC™ is the EDC system of Data Management 365 (DM365). The “MainEDC export” screen reads its export as it is, checks it and turns it into one Excel workbook that the other tools of the portal understand.

The export is checked and becomes an Excel workbook that the tools of the portal read.

How to use it

1. Open YouEDC Studio → MainEDC export.
2. Choose the export archive (or several files) and confirm that it has no names or other direct identifiers.
3. Click “Check the export”. The portal shows the forms, subjects, sites and visits, and everything the checks found.
4. If all is well, click “Download the workbook” and upload it to the tool you need.

Step 2: the archive is chosen and the confirmation ticked. Below are the buttons of the built-in example.

Step 3: the result for the ProjectToOneFile example. The AE form came from its own sheet with a row number, so it is repeating; 67% means two subjects out of three have adverse events. Initials were left out of the workbook.

What you can upload

The portal reads MainEDC exports in their native form, as MainEDC produces them:

• ProjectToOneFile (ZIP or XLSX): a “Main” sheet with a row per subject and columns named VISIT_FORM_FIELD (V1_DM_SEX), a second row with field labels, and a sheet per repeating table (adverse events, medications, history) with a “Row number” column. The portal splits the columns into forms and moves the visit code into the Visit column.
• Modular (XLSX): a long table with a row per value (Site #, Subject Screening #, Visit name, Form name, Table row #, Variable name, Variable Value). The portal builds the forms from it: a row per subject, visit and line, a column per variable. Decoded values and MedDRA, ATC and ICD codes get their own columns; inactive values and deactivated forms are left out.
• The “Data export cover page” sheet and CheckSums.txt are read as the passport of the export: type, trial code, export date, number of subjects and sites.
• Other files: CSV, TXT, XLSX per form or SAS XPT, also in one archive. Encoding and separator are detected automatically.

Initials are not copied into the workbook: the portal does not need identifiers of subjects. The “eCRF field history” is the audit trail, not form data; the portal recognises it and does not take it for forms. PDF exports are not read.

What is checked

• Key columns of every form: site, subject, visit, form and line number, found by their usual names (Site, Subject, Visit, Line and their Russian equivalents).
• Rows and subjects of every form, and the share of all subjects of the study it covers.
• Rows without a subject, a subject at two sites, repeated rows with the same subject, visit and line number.
• Technical columns (change and export dates) and empty columns.

The workbook

The workbook has a sheet per form: first the columns Site, Subject, Visit, Line, named the same on every sheet, then every column of the form as exported. “Export to CDISC ODM” reads the whole workbook, a sheet per form. Tools for one form (“What changed”, SAE reconciliation) read the first sheet, so save the sheet you need on its own or upload that form’s CSV from the archive. MainEDC itself has no ODM export, and the portal makes one: upload the workbook or the archive itself to “Export to CDISC ODM”.

Example file

The built-in examples follow the layout of real MainEDC exports, with made-up data of the study DEMO-MAIN: the ProjectToOneFile archive and the Modular export. This is the start of the “Main” sheet:

Screening #	Randomization #	Initials	Site #	Status	V1_DM_SEX	V1_VS_VSORRES_BPS	V2_VS_VSORRES_BPS
					sex	systolic blood pressure	systolic blood pressure
01-001	R-101	А-Б	01	Randomized	M	128	122
01-002		В-Г	01	Screen failure	F	117

And this is the VS form on its sheet of the workbook: visits V1 and V2 became rows, the key columns are named the same on every sheet, and there are no initials.

Site	Subject	Visit	Line	Randomization #	Status	VSORRES_BPS
01	01-001	V1		R-101	Randomized	128
01	01-001	V2		R-101	Randomized	122
01	01-002	V1			Screen failure	117

The layout is checked on real MainEDC exports. The demo study they came from had no subjects, so the look of the values (dates, answer codes) is still an assumption that we will check on an export with data. If the portal reads your export wrongly, send us an anonymised example. Files are not stored: the log keeps only the number of forms, subjects and rows and the hash of the workbook.

MainEDC™ is a trademark of DM365.