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