1. Data Management Processes

2. Data Management Data management processes Data management overall Data management in the Regional Trial Offices (RTOs) Common data management issues Issue solutions and suggestions

3. Data Management in RTOs 1.Forms logged on arrival in RTO 2.Double data entry – ‘Processed’ 3.Data comparison 4.Data validation – Queries generated 5.Query resolution 6.Valid forms sent to Oxford in Upload file

4. Data Management in ICC 1.Encrypted data received by email 2.Data decrypted - added to ICC Database 3.Text fields coded 4.Data validation – anomalies identified 5.Clarifications & Queries sent to RTOs 6.Query resolution 7.Clean data!

5. After Delivery Forms For the 3946 trial entries: 3837 After Delivery forms have been logged 3645 After Delivery forms have been entered and sent to Oxford (92.4%)

6. Postpartum Forms For the 3946 Trial Entries: 3814 Postpartum forms have been logged 3613 Postpartum forms have been entered and sent to Oxford (91.6%)

7. Six Week FU Forms For the 3264 women who are due follow-up at Six Weeks 2986 Six Week forms have been logged 2934 Six Week forms have been entered and sent to Oxford (89.9%)

8. Regional Trial Offices Showing data logged as in the RTO

9. Common Data Management Issues

10. Trial Entry Q10 – In labour? Data Collection Booklet (DCB) pages 1 and 2 If the woman is/has been in labour = No Not/has not been in labour = Yes After Delivery Question 7b

11. Trial Entry Q10 Solutions DCB stamp RTO staff to clarify response during recruitment phone call Training issue –Refresher training for existing staff –Included in training for new staff On screen prompt at RTO - weekly report of inconsistencies

12. After Delivery Q1 - Parity Data Collection Booklet Page 2 Data Collection Booklet definition: Multiple births Number fetuses < parity

13. After Delivery Q1 Solutions All existing parity queries rectified by consulting patient notes Query now captured by programme at RTO Training issue –Refresher training for existing staff –Included in training for new staff

14. Serious Adverse Events (SAEs) The following events should be reported within 48 hours: –All maternal deaths –Severe haemorrhage (transfusion of ≥ 6 units blood) –Repeat laparotomy or hysterectomy –Admission to Intensive Care Unit –Any other serious unexpected events

15. Serious Adverse Events (SAEs) Not all SAEs are being reported Captured by a query on Postpartum data –Admission to Intensive care –Answers to Q7 and Q8 –Q9 – outcome is Death

16. Serious Adverse Event Solutions Query raised by ICC if SAE form not logged Prompt to complete an SAE form at Regional Trial Office

17. Accuracy… Accurate data essential to the trial The whole study is based on the data entered at the RTOs Data can be not be changed without justification Reasons must be provided – audit trail

18. Accuracy Frequent requests to edit incorrectly entered data –Data entry errors – should be minimised by double entry – Trial Entries are not double entered –In response to clarifications and queries report from ICC – patient notes consulted –Trial Entry errors – query report at RTO shows inconsistencies

19. Accuracy Solutions Clarifications of Trial Entry answers by RTO staff during randomisation phone call Training issue –Refresher training for existing staff –Included in training for new staff –Review training to include areas often answered incorrectly e.g. Trial Entry Q10 Crib sheets/posters –Many staff only recruit to CORONIS occasionally