Clinly — Export Center

Study

Subject

Date Range

Include

Choose Export Format

📊

Excel / XLSX

Multi-sheet workbook — one sheet per form. Includes summary, data dictionary and audit sheet.

Estimated size: ~180 KB

📄

CSV (Flat)

One CSV per form. Compatible with SAS, R, Python, and SPSS without transformation.

Estimated size: ~42 KB (zipped)

🔬

CDISC ODM-XML

FDA/EMA-compliant ODM 1.3.2 format for NDA/BLA submissions and SDTM mapping.

Estimated size: ~320 KB

📋

Audit Trail PDF

Complete immutable audit log. Digitally signed, 21 CFR Part 11 compliant. Includes all 152 entries.

Estimated size: ~2.1 MB

🧬

SAS Transport (XPT)

SAS Version 5 transport files mapped to SDTM domains (DM, AE, LB, VS, EX). FDA preferred format.

Estimated size: ~95 KB

🗄️

JSON / API

Full study JSON with schema, data dictionary, all records and complete audit trail — machine-readable.

Estimated size: ~440 KB

ODM-XML Preview

CDISC ODM 1.3.2

<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3"
     ODMVersion="1.3.2"
     FileOID="FLAURA2-export-20250301"
     FileType="Snapshot"
     CreationDateTime="2025-03-01T14:32:00"
     Originator="Clinly">
  <Study OID="FLAURA2">
    <GlobalVariables>
      <StudyName>Osimertinib ± Chemotherapy in EGFR-Mutated NSCLC</StudyName>
      <StudyDescription>FLAURA2 Phase III</StudyDescription>
      <ProtocolName>FLAURA2-v3.2</ProtocolName>
    </GlobalVariables>
    <MetaDataVersion OID="MDV.1" Name="v1">
      <Protocol>
        <StudyEventRef StudyEventOID="SE.SCREENING" Mandatory="Yes"/>
        <StudyEventRef StudyEventOID="SE.C1D1" Mandatory="Yes"/>
        <!-- 13 more visits... -->
      </Protocol>
      <FormDef OID="F.DEMOGRAPHICS" Name="Demographics">
        <ItemGroupRef ItemGroupOID="IG.DM" Mandatory="Yes"/>
      </FormDef>
      <!-- 21 more forms... -->
    </MetaDataVersion>
  </Study>
  <ClinicalData StudyOID="FLAURA2" MetaDataVersionOID="MDV.1">
    <SubjectData SubjectKey="TEST-001">
      <StudyEventData StudyEventOID="SE.SCREENING">
        <FormData FormOID="F.DEMOGRAPHICS">
          <ItemGroupData ItemGroupOID="IG.DM">
            <ItemData ItemOID="I.BRTHDTC" Value="1968-04-15"/>
            <ItemData ItemOID="I.SEX" Value="M"/>
          </ItemGroupData>
        </FormData>
      </StudyEventData>
    </SubjectData>
  </ClinicalData>
</ODM>
        

Recent Exports

Date	Study	Format	Size	Requested By	Status
2025-03-01 10:14	FLAURA2	ODM-XML	318 KB	Dr. Sarah Chen	Complete
2025-02-28 16:30	FLAURA2	XLSX	182 KB	Dr. Sarah Chen	Complete
2025-02-15 09:05	PLANETTE	CSV	38 KB	Dr. Sarah Chen	Complete