1 Case study of eCRF implementation in a neurological clinical trial with CT scans

2 Randomised, double-blind, placebo controlled study Phase IIIb 100 centers in 15 european countries 800 patients to be included in 3 years 3 months follow-up per patient 2 to 4 CT-scans per patient (2400 scans planned in total) Study type

3 Data Chart

4 3 experts must review all CT scans to check inclusion criteria, adverse events and make radiological measurements Experts 1 and 2 review CTs independantly Expert 3 will review Experts 1 and 2 evaluations, and in case of discrepancy, will give final decision Review Commitee

5 Paper CRF Radiographic films Paper evaluation forms Classical solution : paper and films

6 Investigator IVRS CRO Expert 1 Expert 2 Expert 3

7 Hypothesis : scans ( ) - 10 % will forget anonymization - CT 1 & 2 sent together, CT 3 & 4 sent together =>7200 CT copies initial EM by investigator 120 requests for lack of anonymization 720 additional CTs 120 additional EM by investigator EM from CRO to experts 1 & EM by experts 1 & 2 to CRO 1200 EM from CRO to expert EM by expert 3 to CRO Total : 7920 CT copies express mails Classical solution : measurements

8 Optimistic hypothesis : - invest to CRO : 2 days - CRO analysis and data entry : 2 days - EM to experts 1 & 2 : 1 day - review by experts 1 & 2 : 1 day - EM by experts 1 & 2 to CRO : 1 day - CRO analysis and verification : 1 day - EM to expert 3 : 1 day - review by expert 3 : 1 day - EM by expert 3 to CRO : 1 day =>Best case : 11 days if anonymization required : + 3 days = 14 days Pitfalls : - difficult measurements with films - requires double data entry by CRO Classical solution : measurements

9 Paper CRF for investigator Electronic images copied onto CD-Rom Electronic evaluation forms Electronic solution (75 %)

10 Investigator IVRS Expert 1 Expert 2 Expert 3 CRO

11 Hypothesis : scans ( ) - 10 % will forget anonymization - CT 1 & 2 sent together, CT 3 & 4 sent together =>1200 CD roms burnt by investigator initial EM by investigator 240 anonymization by CRO no additional CD-Roms no additional EM by investigator 2400 upload by CRO in database no EM from CRO to experts 1 & 2 no EM by experts 1 & 2 to CRO no EM from CRO to expert 3 no EM by expert 3 to CRO Total : 1200 CD-roms express mails Electronic solution : measurements

12 Optimistic hypothesis : - invest to CRO : 2 days - CRO analysis and data entry : 2 days - EM to experts 1 & 2 : 0 day - review by experts 1 & 2 : 1 day - EM by experts 1 & 2 to CRO : 0 day - CRO analysis and verification : 0 day - EM to expert 3 : 0 day - review by expert 3 : 1 day - EM by expert 3 to CRO : 0 day =>Best case : 6 days if anonymization required : + 1 day = 7 days Advantages : - electronic images allow digital measurements - anonymization can be done by CRO electronically Electronic solution : measurements

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14 Direct access to data for all authorized users Real-time follow-up Audit trail Alarms Performance measurements Investigators can access experts evaluation Electronic images and measurement tools Other advantages

15 Encryption Electronic signature Profile management Audit trail Database protection (firewall, physical security) Back-ups Security issues