Entering Information in Korean Specific Data Elements

This screen enables you to perform data entry, related to Korean specific data elements required for E2B R3 file. The specific R3 tags are mandatory for the MAH’s while exporting and importing an R3 ICSR file.

In addition to Korean Regional screen, the below mentioned fields are available in the Full Data Entry.

When you enter information or modify any of the mentioned fields, the corresponding field is updated in the other location.

For information on the above sections, refer to the corresponding sections on Full Data Entry screen.

All the fields on Korean screen and Korean Unblinded Screen are read-only fields, except the ones mentioned in the list below:

Section	Field Name	Description
Reporter	Other HealthCare Professional	Indicates if the person also works as other health care professional. The options are: · Other · Nurse
Study	Other Examination details	Indicates any other examination details for the study. Select one of the following options: · Re-examination report, Post-Marketing Surveillance · Re-examination report, Post-Marketing Clinical Trial · Re-examination report special Investigation · Other
	MFDS Serial Number (C.5.3)	Indicates the MFDS Serial Number for the study protocol.
Product	WHO DD Code	Select the WHO DD Code from the look-up. When the WHO DD code is selected from the look-up, then the WHO DD MPID gets displayed automatically. Note: The auto population of the WHO DD MPID occurs only if the installation parameter, ' Allow WHO DD to KDD coding' is selected and not otherwise. Also, if the CPD/Ingredient library has the MPID number, then the CPD/Ingredient library data shall be considered, and it does not consider the ‘Allow WHO DD to KDD coding' parameter.
	Korean Drug Code	The information is displayed from the Korean drug dictionary stored in LibraryàCompany ProductàApproval Information screen. When the WHO DD code is selected from the look-up, based on the MPID, the matching KDD code gets displayed automatically. The KDD auto population considers the following logic: 1. If there is no match found for the MPID fetched, the application does not display any value in the KDD code and decode field. 2. If there is one to one match – the application automatically displays the KDD code based on the WHO DD code selected (if the new parameter is selected to code KDD based on WHO DD) 3. If there are one (WHO DD) to many (KDD) matches, then you may select the appropriate KDD with the help of the available Autocode KDD Code option. NOTE : The Korean drug code is auto populated only if the installation parameter ' Allow WHO DD to KDD coding' is checked and if the CPD also has KDD code, then the CPD data shall be considered and does not consider the above parameter.
	Autocode KDD Code	Select the Autocode KDD Code to choose the appropriate KDD. The Autocode KDD Code is available only if the primary source country is selected as Korea Republic. Else, this field remains invisible.
Ingredients	KDD Ingredient Code	The information is displayed from the Korean Ingredients Lookup, stored in LibraryàCompany Productà Active Ingredients. The KDD Ingredient Code is displayed automatically based on the CAS Number. Auto population of KDD Ingredient Code is applicable only for domestic cases & the installation parameter 'WHO DD to KDD auto coding' should be enabled in Admin > 'Date/Dictionary Parameters' tab. Note: If the CPD product at ingredient level has KDD ingredient value, then the same shall be considered and does not auto populate the KDD Ingredient Code.
	CAS Number(G.k.2.3.r.1.KR.1b)	Enter the CAS number or ,use the CAS Number Lookup, to capture the CAS number and the Substance Name of the drug. i.e. the unique number assigned to every chemical substance by Chemical Abstracts Service (CAS). The CAS Number is displayed automatically based on the Substance Name. Auto population of substance name is applicable only for domestic cases & the installation parameter 'WHO DD to KDD auto coding' should be enabled in Admin  'Date/Dictionary Parameters' tab. Note: The case is considered as Domestic, if the Primary source country is set to 'Korea ,Republic of' or Country of primary reporter is set to 'Korea ,Republic of' with primary source for regulatory submission selected.
Event	Reported Term in Native Language (E.i.1.1a)	Enter the literals of the term as received by the reporter in the native language.
	Native Language (E.i.1.1b)	Select the native language from the drop-down list.
Causality	Korean Source	The Korean Source of Assessment.
	Assessment Method	The method of capturing the Korean causality assessment. The following methods are used for assessment: WHO-UMC Evaluation Result (G.k.9.i.2.r.3.KR.1) KRCT Evaluation Result (G.k.9.i.2.r.3.KR.2)
	WHO-UMC Evaluation Result	Captures the WHO-UMC Evaluation results. The available options are: · Certain · Probable · Possible · Unlikely · Conditional/unclassified · Unssessable/unclassifiable · Not Applicable
	KRCT Evaluation Result	Captures the KRCT evaluation results. The available options are: · Related · Not related
	Manual	Selection of this check box does not automatically calculate the Korean Causality information.
Case Summary and Reporter's Comments Text (H.5.R.1a)		Enter the case summary information about Product, Drug administered, and outcome, etc., in addition to the information provided by the reporter. The information provided in this field is translated into the native language of the country or region other than English, where the report is submitted. This translation is based on the International Standard Codes for the languages.
Native Language (H.5.r.1b)		You can enter the case summary and reporter’s comments text in your native language by selecting the native language from the drop-down list.

The application supports the printing of fields in AER Data Report, Detailed Audit Report and Brief Audit Trail Report.