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RDC Onsite and eCRF

Boehringer Ingelheim1230.14 POLO-AML-2

Toronto 23 February 2013Investigator’s Meeting

23 February 2013

Contents of the Presentation

1. General Information about RDC Onsite

2. Data Entry

3. Discrepancy Management

4. eCRFs: Changes in CTCAE Grade Coding of AE Eligibility for Further Course Trial Termination

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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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RDC Data Flow

• 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

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day 1

day 2

day 3

Data entered

Query resolutionquery

Example:

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Electronic signature for approval of eCRFs

is implemented by

use of username and password

(Keep your password private!)

What Does Approval Mean within RDC?

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• 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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RDC Onsite Homepage

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TabsLogout

Login name and job function

Study and site drop-down lists

Patient search

Instruction for CRF

completion links

Patient icon

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eCRF Page Structure

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Casebook

Patient

statusPage

number

CRF footer

CRF body

CRF header

Patient number

Blank page status box

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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

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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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Discrepancies

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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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Adverse Events Form

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Only one AE is recorded per eCRF.

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AE Outcome and End Date

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Cross check AE end date with AE outcome.

If the outcome of the AE is

„Recovered“ or „Fatal“, the end date should be

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Serious Adverse Events

　

Follow SAE reporting

procedures

Select all criteria that apply

　

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Entries on the SAE form need to be consistent with entries on the

eCRFPlease check when

entering or updating SAE data

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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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’.

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AE Name Start Date End Date CTCAE Outcome

Febrile Neutropenia

23Nov2012 24Nov2012 3 Not yet recovered

Febrile Neutropenia

24Nov2012 25Nov2012 4 Not yet recovered

Febrile Neutropenia

25Nov2012 26Nov2012 3 recovered

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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:

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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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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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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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Eligibility for Further Course – eCRF Completion

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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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Termination of Trial Medication

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The date of last drug

administration should be known and entered for

each patientWhen 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

23 February 2013