ICH guidelines- Summary of E2B

ICH guidelines- E2B Data elements for  Transmission of Individual Case Safety Reports (ICSRs)

 

As we talked about some pointers from ICH guidelines in my last post  E2A, in this post i will try my best to take out summary of E2B guidelines. Summarizing E2B guidelines is very difficult because it has multiple layers scattered over multiple documents. 

This document describes the requirements of reporting ICSR in clinical trials. 

Reference here https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf

CLINICAL SAFETY DATA MANAGEMENT : DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS E2B(R2)

Summarizing a high level points from the module for revision below.

1.  Minimal information

• one identifiable patient - any one of several data elements is considered sufficient to define an identifiable patient (e.g. initials, age, sex); 
• one identifiable reporter - any one of several data elements is considered sufficient to define an identifiable reporter (e.g. initials, address, qualifications); 
• one adverse event/reaction (or outcome); 
• one suspect or interacting drug.  
• Sender’s (case) Safety Report Unique Identifier 
•  Type of Report
•  Date of Most Recent Information for This Report
•  Dose This Case Fulfil the Local Criteria for an Expedited Report? 
•  Worldwide Unique Case Identification 
•  Reporter’s Country Code 
•  Sender’s Organisation 
•  When type of report=‘Report from study’, Study Type Where Reaction(s) / Event(s)Were Observed

This applies to all types of ICSRs including initial case reports, follow-up information, and cases to be amended or nullified. 

All the information available should be reported in fully structured format using the relevant E2B(R3) data elements and applicable standard terminologies. 

Those terminologies include; ISO (country codes, gender codes and language codes), MedDRA (e.g. medical history, indication, and reaction / event), UCUM (units of measurement), and ISO IDMP (see Section 3.2.1.1 for details).

2. Some pointers:

• ‘Future dates’ cannot be transmitted in an ICH ICSR message.
• Metric units should be used exclusively. 
•  For ICSR reporting, MedDRA is commonly used in the ICH regions.
• Defintion and details on when to use null flavours, unknown and blanks
• ICH recommends that when a poorly documented case is reported, then the clinical judgement should be exercised
• For the cases being reported from health authorities where the qualification of reporter is not found, then primary reporter is health authority and qualification of reporter to be entered as unknown.
• ICH database does not accept values such as < and > in its format. They recommend using standard website for providing standard units and values, like lab values units to be referred from http://unitsofmeasure.org/track

While i have tried my best to explain things, original guidelines should or has to be refereed, my understanding may not replace or be substitute to them at all.

Written by:

Dr.Shraddha Bhange.

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