1. Change/Insert Date & Location via >Insert >Header & Footer 1. Check in Date & Time 2. Type under >Fixed 3. Check in Footer 4. Fill in field 5. Click Apply to All To view drawing guides 1.Right-click outside slide and select ’Grid and Guides...’ 2.Check ’Display drawing guides on screen’ 3.Select ’OK’ Clinical Study Data Processes @ LEO Pharma p. 01 9 May 2015

2. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu Process overview Data Capture and Management Standards and Validation TFL and Statistics Reporting and Submission 9 May 2015 p. 02 eCRF Oracle Clinical - MedDRA - WHO Drug CRO’s CDISC - SDTM - ADaM - Controlled Terminology OpenCDISC Tables Figures Listings Analyses 21 CFR part 11 - Repository eDoc Define.xml Pooling Publish Submission

3. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu CDC repository Data Capture and Management CRF pages built in OC ◦ Standardisation critical CRF pages from eCRF Data Management in OC ◦ MedDRA ◦ Who Drug CRO outsourcing ◦ Standardisation critical SDTM ◦ From 2005 ◦ Standardisation benefit & critical OpenCDISC Validator ◦ Standardisation benefit 9 May 2015 p. 03 SDTM OC CRO OpenCDISC Validator eCRF

4. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu CDC repository Standards and Validation Depends on standard SDTM ADaM since 2006 Standards allow for study variations Standards covers format, not contents Complex 21 CFR part 11 compliant 9 May 2015 p. 04 SDTMADaM Metadata SAPU SAS Code

5. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu CDC repository TFL and Statistics Standardised/modifiable Parameter based Partly automated Configurable Analyses not standardised Analyses ad-hoc per study 21 CFR part 11 compliant 9 May 2015 p. 05 SDTM ADaM TFL Metadata Spread sheet SAS Code

6. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu CDC repository Reporting and Submission Not always performed Pooling dependent of standards define.xml ditto (documentation) If data standardised, submissions in weeks Closed transfer between validated systems 21 CFR part 11 compliant 9 May 2015 p. 06 Study data Pooled data define.xml eDoc etc. eDoc Publish

7. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu QC processes Risk based QC strategy The most important and most critical parts Primary and secondary end points QC of additional parameters if applicable Applies to CRF, SDTM, ADaM, Tables, Listings, Figures, Analyses, Poolings, define.xml and everything else relevant Any deviation from standards requires additional QC Greater adherence to standards yields shorter production time of input to the CSR (months => weeks) 9 May 2015 p. 07

8. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu Conclusions Clinical Study Data Processes are quite mature Years of experience in CDSIC standards 21 CFR part 11 compliant end-to-end Strong focus on standards yields ◦ Automatisation ◦ Flexibility ◦ Quick CSR More elements needs to be standardised ◦ Protocol, CRF, Figures, Analyses, define.xml, Pooling, Submissions, Data standards upgrades 9 May 2015 p. 08

9. To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint menu Questions 9 May 2015 p. 09