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CDM Process
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Clinical Data Management
Overview
Mission Responsibility Process
1. Discrepancies Management2. Medical Coding and CTCAE
CRF Filling Instructions Reminders
Mission of CDM Consistency Accuracy Validity Archiving
High Quality Data is needed to perform statistical analysis
CRF Entry Cleaning
DM process
Stat. Analysis
Challenge Error rate 0%
Responsibilities of CDM Responsibilities
Protocol Review CRF Design / Review Clinical DB Application Development Computer System Validation CRF tracking Data Entry / Verification Transformation to SAS data Medical Coding : AE, Medication, Medical
condition
Responsibilities of CDM
Responsibilities Audit trails - Transparency DB QA DB Security and Archiving Regular DB backup
CDM Process
Database designDatabase design
Protocol Review & CRF Design/ReviewProtocol Review & CRF Design/Review
Development StageDevelopment Stage
Data validation programData validation program
Data entry applicationData entry application
Pre-entry reviewPre-entry review
Double data entry Double data entry
Data Processing StageData Processing Stage
Unmatched checkUnmatched check
Logical checkLogical check
Discrepancies mgt.Discrepancies mgt.
Closing StageClosing Stage
Medical codingMedical coding
DB lockDB lock
Validation of SAS data set Validation of SAS data set
Transformation to SAS dataTransformation to SAS data
CRFs managementCRFs management
CDM Flowchart
Data Entry
Approved Blank CRF and Protocol
Quality Control of Database and Database go live
Batch Validation
Medical CodingQA/QC of data
CRF Annotation, Edit Specification Document Preparation
Database Lock & Statistical report
generation
Database Design Setup
Test Data Entry
CRF’s completed
at site.
CRF Receipt and Tracking in Data Center
Maintaining Missing & pending pages log Discrepancy Mgt.
Pre-Data Entry Review
Discrepancy Management
Why discrepancy
Types of discrepancy
Methods to resolve discrepancy
Why discrepancy?
Data complete?
Data consistent?
Discrepancy
Data correct?Data logical?
Data legible?
Discrepancy Type
Missing Illegible Range Date Logical
Discrepancy Resolve Methods
Self Evident- discrepancies which are resolved by Data Coordinator. Ex: Details of concomitant medication are given but Yes/No
field are not marked. CRA/Medical Monitor- discrepancies
which are resolved by CRA or Medical Monitor.
Discrepancy Resolve Methods
Query- Discrepancies which are resolved by Investigator.
Ex: Start date of Adverse event not supply.
Query has been send to investigator by Data Clarification Form (DCF)
Medical Coding
Why Medical coding Different sites, Different culture, different time-zones, different
physicians and various other factors leads to variation in the data entered in particular fields which cannot be effectively controlled. This varying fields require coding.
Methods 1. Auto-Coding2. Manually3. Combination of Both
MedDRA
Med = Medical D = Dictionary for
R = Regulatory A = Activities
FDA and EU mandated for AE data coding
Objectives for MedDRA Development An international multi-lingual terminology
Standardized communication between industry and regulators
Support of electronic submissions
Application through all phases of the development cycle
Objectives for MedDRA Development Classification for a wide range of clinical
information
Support for multiple medical product areas
A terminology that saves time, resources, and money
MedDRA Is Designed For Coding: Signs (i.e. Redness) Symptoms (i.e. Dizzy) Diseases (i.e. AIDS) Diagnoses (i.e. Hepatic failure) Therapeutic indications (i.e. Congestive heart
failure) Names and qualitative results of investigations (i.e.
Increased SGOT) Surgical and medical procedures (i.e.
Cholecystectomy) Medical, social, and family history (i.e. Alcoholism)
Not Code able Term A single event description contains multiple conditions. Ex:
Leg red, swollen, and painful An event term contains a diagnosis and a symptom. Ex: Fever
and Cold The event term can be interpreted more than one way. EX:
Unable to focus The event term does not make sense. Ex: Left leg The event term is foreign Event term contains a question mark Improvement of a condition is implied, but the term does not
state it is a benefit. Ex: Sleep improved
CTCAE Common Terminology Criteria for Adverse
Events (CTCAE) They consist of the name of the area of interest
and a grading which refer to the severity of the reaction: grade 1 (mild AE) to grade 5 (fatal)
The actual medical condition may differ depending on the severity criteria
More than one medical condition may be covered by the same CTCAE grade
CTCAE Codes for Abnormal Lab Results
CTCAE v3.0 Term
Grade 1
Grade 2
Grade 3
Grade 4 Grade 5
Prolonged QTc interval
QTc 450 - 470 msec
QTc 481 - 500 msec
QTc >=501 msec on at least two separate EKGs
QTc >=501 or >60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
Death
CRF Filling Instructions Authorized individuals
Block Letters and avoid over writing and writing out side the provided space
Strike off all the blank pages with initial and date.
Do not write in shaded area
Sign and date CRF pages ,where requested
CRF Filling Instructions Subject Initials: Must be the same throughout
the study. If the subject does not have a middle initial, ‘-’ should be used instead of
‘X’. e.g. Brian Jones should be recorded as: |B|-|J|
CRF Filling Instructions Errors:
Error will be cross out with single horizontal line and write correction next to it. Initial and date the correction.
e.g. |1|5|/|0|4|/|2|0|0|4| 2005 CJW 15/04/2005
Wrong practice which is not acceptable |1|5|/|0|4|/|2|0|0|4|
Do not use correction fluid, pencil or red ink. Make Sure that the error, although crossed out, remains legible
CRF Filling Instructions
Dates: Record the actual date of the visit.
The order of entry in the date format is Day, Month, Year (07/01/2007). Day, month and year are to be expressed numerically.
Correct entry for complete date: |0|7|/|0|1|/|2|0|0|7| DD MM Y Y Y Y
In the absence of a precise date for events and therapies that precede the subject’s inclusion into the study, incomplete dates should be recorded as follows:
Correct entry for incomplete date: |N|K|/|N|K|/|2|0|0|2| (NK: Not Known)
Reminders Adverse Event Log: Parasitological Assessment Log: Body Temperature log: Vital Signs Log: Prior and concomitant medication Log: PK Sampling Log: Physical Examination Log: Assessment of clinical Signs and Symptoms Log: 12 Lead ECG Log:
Reminders If ECG is CS or QTc is > 500 msec,
Should be reported as AE.
Any increase in grading of signs and Symptoms from previous day should be reported as AE.
Please exclude the Subject, if axillary temperature is < 37.5 ºC or oral temperature is < 38° C.
Reminders In Clinical Signs and Symptoms, Please enter only One
CTCAE Grade.
Clinically significant (CS) abnormal laboratory tests must be followed up as described in the protocol.
Did the subject develop any sign or symptom of severe malaria?
If Yes, the subject withdrawn from trial.
If Pregnancy test is “positive” complete ‘Notification of Pregnancy’ report
Reminders Exclude the subject if QTc interval >450msec. Use Fridericia’s formula to calculate QTc Please Exclude the Subject if weight is less than 35 kg.