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Discrepancy

                                                             DISCREPANCY

Note: FULL FORMS ARE BELOW THE INFORMATION

Definition

Inconsistency or some mismatch or deviation from a reference data in clinical study

Discrepancy can be

DATA-----inaccurate, incomplete, illogical, missing or not in accordance with study protocol specification

In clinical study
            ||
            ||
            ||
    Discrepancy
            ||
            ||
Often Observed in
trial data although ================>Trial data transcription is done carefully & accurately from 
                                                                      source documents


Discrepancies===========>systemic way
            ||                                          ||
            ||                                          ||
        Process                                   ||
                                                       ||
                                                  identify & manage ============>Discrepancy Management

Generation:

Discrepancies occurs many sources

  • Where there is an error in data entry
  • Investigator reports some incorrect values ( example: Lab values)
Examples:  Empty fields
                   Incorrect range
                   Data not in logical sequence 
                   Any missing visit or pages
                   Lab values not in normal range
                   Inclusion/Exclusion criteria not met etc.....

Identification of Discrepancies

Identification of Discrepancies ===> 1) Done through manual checks
                       ||
                       ||
                       ||
                       ||
     2) Done through Programmed checks ==========>most of the discrepancies  identified by PC
                   ||                                                                                             ||                                      
                   ||                                                                                             ||                         
                   ||                                                                                 Done by CDMS
                   ||
                   ||
                   ||
                   ||
                   ||
            These are automated checks ====>Edit checks

TWO(2) Kinds of Discrepancies 
  
1) System generated                                                                   2) User generated 

Programmed identified with help of                                               Cannot be programmed identified 
in built edit checks                                                                           during manual review
eg: Pregnancy box                                                                           eg: reconciliation of safety data
      says "YES" Gender
      says "NO" 

Resolution

Resolution to a query whether paper or EDC can be

  • Correction to the data
  • A conformation the data is not available
  • A note that although the triggers a discrepancy, that data really is correct as its stands
                         sent                          for
Discrepancy-------------> trial site----------->Resolution ------------>Query 

EDC system
                      ============ ↷              because when                                  Becomes                            
 Discrepancy  ||            |                Query  =============>  Discrepancy =========> Query          
                      ============⤴
                                   ⬇
                           Interchange
                                term     


           enter
Site=========> EDC ( With help of edit checks)
           data                  || 
                                   🠟                           
                             Discrepancies identified automatically
                                  🠇
                              Resolved 
                                   ⮟
                                   ⮟   valid & manual review done by
                                   ⮟
                              Data manager

Data manager ➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤  verifies updated information &
        🠇                                                                                                   ⮟            lock data
It identify Discrepancy                                                                         ⮟
    in eCRF                                                                                            ⮟
        🠇                                                                                                   ⮟
   Query raised                                                                                      ⮟                   
        🠇                                                                                                   ⮟     
Trial site professional ➤➤➤➤➤➤➤➤➤➤➤➤➤➤➤ update data into EDC system                                                                                                                               
     address queries 

                                   then                                                        but
 Data correction---------------------> Original query closes-----------------> manually created query does 
(done by site staff)                                   |                 |                                   not close automatically
             |                                                   |                 |                                         |
             |_________________________ |                 |____________________ |                                         
                     In case does not involve                                         ⇊                                        
                                                                                   then it is important to check
                                                                                                     ⇓
                                                                                     Manually the process----------->Possibility of
                                                                                                     ⇩                                         ⬇
                                                                                     Because it can leads                   unsuitability of 
                                                                                                                                            original answer
                                        

                  contain                                    encloses
CDMS------------------>  Discrepancy ----------------->  All discrepancies --------> that will be 
                                          data base                                                                           recorded &stored                                             ∕         |                                                                                           ⬇                  
                                  ∕            | checks                                                                        that will be 
                               ∕               |                                                                                     recorded&
                           at             CDM                                                                                stored with
                         regular                                                                                               {Audit Trial}
                       intervals     

 * The resolved data discrepancies are recorded as " closed " . In some cases, trial site staff are unable to resolve some discrepancies. Such discrepancies will be considered as " irresolvable" and the same will be updated in the discrepancies database.

FULL FORM
  • CDMS: Clinical Data Management System
  • eCRF: Electronic Case Report Form
  • CDM : Clinical Data Management
  • EDC: Electronic Data Capture
  • PC: Production Changes
                                                         


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