1. Investigator’s Meeting
Boehringer Ingelheim
POLO-AML-2
RDC Onsite and eCRF
Toronto 23 February 2013
Investigator’s Meeting
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23 February 2013

2. Contents of the Presentation
General Information about RDC Onsite
Data Entry
Discrepancy Management
eCRFs:
Changes in CTCAE Grade
Coding of AE
Eligibility for Further Course
Trial Termination
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23 February 2013

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1. General Information about RDC Onsite
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What is RDC?
Remote Data Capture is a web-based application that enables the user to enter the clinical data into the electronic Case Report Form (eCRF).
Data is entered directly in the clinical database of Boehringer Ingelheim.
Several user roles available:
Investigator role　(Only PI has page approval privilege)
Site role
CRA role
Data Manager role
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5. RDC Data Flow day 1 day 2 day 3 Data entered Query resolution Example:
Data should be entered within 2 days of the patient visit
Resolve queries promptly
Investigator approves entered data on an ongoing basis, not just  “at the end of the trial” (visit by visit)
Data changes need to be re-approved by investigator
Electronic signature for approval of eCRFs
is implemented by
use of username and password
(Keep your password private!)
day 1
day 2
day 3
Data entered
Query resolution
query
Example:
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6. What Does Approval Mean within RDC?
Approval within RDC documents that the investigator agrees that the data as given represent the patients‘ conditions in the course of the trial.
Approval gives the investigator the control over the contents of the data.
BI will lock the database based on the approved data. For this reason, all data that has been entered including blank pages, MUST be approved at the end of the trial.
Investigator can approve per visit, and on page basis each time a change was made.
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7. Login name and job function Logout Tabs
RDC Onsite Homepage
Login name and job function
Logout
Tabs
Patient search
Study and site drop-down lists
Instruction for CRF completion links
Patient icon
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eCRF Page Structure
Patient number
CRF header
Blank page status box
CRF body
Patient status
Casebook
Page number
Removed “visit date” feild
CRF footer
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2. Data Entry
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General Rules
Use English only
Do not use special characters like ®, µ, β blocker
Do not enter any information other than expected in the data fields (e.g. “Not done” (ND) should NEVER be written in any entry fields)
Issue: If an examination was not performed.
Solution:
Please leave the field blank.
If a query appears, please enter "ND" in the comment field of the query and forward this response back to Data Management.
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Blank Pages
Any individual pages that will not be completed should be ticked as blank
You should also log a complete visit as blank if it was skipped and will not be done at all, but patient continues in the trial (i.e. optional V2 & V4 from Cycle 2)
If a patient discontinues the trial, pages for visits that will not be done should NOT be logged as blank
Example:
20 cycles are set up in the database.
If a patient stops treatment at the end of Cycle 5, visits of Cycles 6 to 20 should remain as not entered.
Please note that End of treatment visit should be completed.
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3. Discrepancy Management
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Discrepancies
Discrepancies are inconsistencies in the information that has been entered in RDC.
This lead to Queries, which are created :
immediately, after a CRF has been saved or after batch validation session (normally automated overnight process). In these cases, RDC detects discrepancies automatically based on pre-defined screening rules.
In other cases, CRAs or TDMs add discrepancies manually.
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14. The person/ system who creates the query
Discrepancies
The person/ system who creates the query
is the only one able to close it.
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4. eCRFs:
Coding of AE
Changes in CTCAE Grade
Eligibility for Further Course
Trial Termination
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16. Only one AE is recorded per eCRF.
Adverse Events Form
Only one AE is recorded per eCRF.
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17. Cross check AE end date with AE outcome.
AE Outcome and End Date
Cross check AE end date with AE outcome.
If the outcome of the AE is „Recovered“ or „Fatal“, the end date should be present
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18. Serious Adverse Events
Entries on the SAE form need to be consistent with entries on the eCRF
Please check when entering or updating SAE data
Follow SAE reporting procedures
For TDM, this is for <RAPID trial>
Select all criteria that apply
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Coding of AE
Record each medical term on a separate AE page in the CRF
Give the diagnosis if known
If a diagnosis has not been established, report symptoms (one per AE page) that describe the untoward medical occurrences. The diagnosis can be added later. In this case, please replace the symptom with the diagnosis and delete all remaining symptoms related.
Signs and symptoms, which are part of the normal pattern of the diagnosis, should not be recorded as adverse events. In such a case, the diagnosis only is sufficient. However, symptoms, which are not part of the normal pattern of the diagnosis, should be recorded as appropriate. 　
=>Cytopenias that are symptoms of AML
should not be recorded as AE
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20. Changes in CTCAE grade of events
Each time the CTCAE grade of an adverse event or a baseline condition changes, i.e. worsens or improves, it should be entered in a new AE page in the eCRF
End date of the original entry = Start date of the new entry = date of the CTCAE grade change
Outcome of the original entry = 2 (Not yet recovered)
Example: The CTCAE grade changes several times, outcome is always assessed as ‘Not yet recovered’, only in the last entry – when “Febrile Neutropenia” is really resolved – outcome should be assessed with ‘recovered’.
AE Name
Start Date
End Date
CTCAE
Outcome
Febrile Neutropenia
23Nov2012
24Nov2012 3
Not yet recovered
25Nov2012 4
26Nov2012
recovered
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23 February 2013

21. Laboratory Tests – Data Entry
Not all abnormal laboratory values are adverse events.
An abnormal laboratory value is recorded as an adverse event if
it is judged clinically relevant by the investigator
And it is not a symptom of an already recorded AE
When abnormal laboratory value is recorded as an adverse event, please consider the AE name with following example:
Not enough information as AE name for it to be coded　(e.g.)
Information , sufficient for coding　(e.g.)
“Glucose”
“Hyperglycemia” OR
“High Glucose”
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22. Laboratory Reference Ranges
Laboratory reference ranges and units for all parameters will be entered ONCE directly into RDC:
Thus it is highly recommended to use same local laboratory (primary) for all patients
Secondary (non-primary) lab reference ranges are captured on a separate eCRFs and all data fields MUST be completed
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23 February 2013

23. Eligibility for Further Course
Based on protocol, a patient is eligible to continue treatment, if the following criteria are met:
Absence of disease progression or relapse.
Recovery from any drug-related non-haematological AE to CTCAE grade less than 2, or baseline, whichever is higher.
The patient is eligible to continue treatment based on investigator’s medical assessment (e.g. Blood count, bone marrow smear, physical examination etc.)
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24. Eligibility for Further Course – eCRF Completion
If patient is NOT eligible to immediately starting the next cycle:
Complete all eCRF pages at Visit 5
Repeat Visit 5 until the patient meets all of the criteria to continue to the next course (Additional visits recommended on weekly basis at investigator’s discretion )
Data for the initial Visit 5
Data for the second Visit 5
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25. Termination of Trial Medication
The date of last drug administration should be known and entered for each patient
When the patient discontinued study medication , select the primary reason for discontinuation.
Indicate if the medication code has been broken.
If yes, please enter the date.
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Questions
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23 February 2013
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