Date post: | 16-Jan-2016 |
Category: |
Documents |
Upload: | brice-warner |
View: | 225 times |
Download: | 1 times |
Data Management Processes
Data Management
• Data management processes
• Data management overall
• Data management in the Regional Trial Offices (RTOs)
• Common data management issues
• Issue solutions and suggestions
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
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!
After Delivery Forms
5%3%
92%
After Delivery forms logged butnot sent to Oxford
After Delivery forms logged andsent to Oxford
After Delivery forms not loggedor sent to Oxford
For the 3946 trial entries:3837 After Delivery forms have been logged3645 After Delivery forms have been entered and sent to Oxford (92.4%)
Postpartum Forms
5%3%
92%
Postpartum forms logged butnot sent to Oxford
Postpartum forms logged andsent to Oxford
Postpartum forms not logged orsent to Oxford
For the 3946 Trial Entries:3814 Postpartum forms have been logged3613 Postpartum forms have been entered and sent to Oxford (91.6%)
Six Week FU Forms
2%9%
89%
Six Week forms logged but notsent to Oxford
Six Week forms logged andsent to Oxford
Six Week forms not logged orsent to Oxford
For the 3264 women who are due follow-up at Six Weeks2986 Six Week forms have been logged2934 Six Week forms have been entered and sent to Oxford (89.9%)
Regional Trial Offices
Showing data logged as in the RTO
Common Data Management Issues
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
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
After Delivery Q1 - Parity
• Data Collection Booklet Page 2• Data Collection Booklet definition:
• Multiple births• Number fetuses < parity
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
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
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
Serious Adverse Event Solutions
• Query raised by ICC if SAE form not logged
• Prompt to complete an SAE form at Regional Trial Office
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
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
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