Data Management Processes

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 • Forms logged on arrival in RTO • Double data entry – ‘Processed’ • Data comparison • Data validation – Queries generated • Query resolution • Valid forms sent to Oxford in Upload file

4. Data Management in ICC • Encrypted data received by email • Data decrypted - added to ICC Database • Text fields coded • Data validation – anomalies identified • Clarifications & Queries sent to RTOs • Query resolution • 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