Click 
to generate report.
The generated MHLW Submission form is used whenever MHLW E2B reports are submitted through postal mail, enclosing floppy disk with E2B files.
To generate MHLW Submission reports:
On the Export Section page, click the MHLW 整理票 button.
Runtime Parameter Field Details Table
|
Field |
Description |
|
出力情報の入力 [Runtime Parameters] |
|
|
再提出 [Resubmission] |
Select はい[Yes] to resubmit the case. Select いいえ[No] not to resubmit the case. |
|
担当者名 [Contact Person] |
Enter the name of the contact person. |
|
部署 [Department] |
Enter the name of the department to which the person belongs. |
|
電話番号[Phone Number] |
Enter the phone number of the person. |
Click to generate report.
The File Download dialog appears.
Click Save and specify the location to store the generated report.
Note: The application allows you to generate only similar type of reports for the cases. The application does not allow you to select both Post Marketing Study and Clinical Study simultaneously for report generation.
Or
Click Open to display the MHLW Submission Report layout.
The MHLW Submission Report page appears.
If you select multiple cases of the same report type, the check boxes are selected in the report and, if it satisfies the criteria in any one of the selected cases, then the report is generated as per the criteria.
Mapping and Printing logic for the Report R8
|
Box No |
Report Field Name[Japanese] |
Report Field Name[English] |
Printing Logic |
|
副作用等報告送付整理票 [Adverse event case report (E2B Report) Submission Form] |
|||
|
98 |
市販後 |
PMS report |
The application enables the check box with "■" when value for PMS report, J.4.a <mhlwadmicsrcasenumclass> tag is 1 to 7. |
|
99 |
治験 |
Clinical Study report |
The application enables the check box with "■" when value for clinical Study report, J.4.a <mhlwadmicsrcasenumclass> tag is 8 to 14. |
|
100 |
国内副作用報告（第一報） |
Local adverse event report (initial) |
The application enables the check box with "■" when value for Local adverse event report (initial), J.4.a <mhlwadmicsrcasenumclass> tag is either 2 or 9, and J.5 < mhlwadmicsrmhlwcumreporttimes> is 1. |
|
101 |
国内副作用報告（追加報告） |
Local adverse event report (follow-up) |
The application enables the check box with "■" when value for Local adverse event report (follow-up), J.4.a <mhlwadmicsrcasenumclass> tag is either 2 or 9, and J.5 < mhlwadmicsrmhlwcumreporttimes> is greater than 1. |
|
102 |
外国副作用報告（第一報） |
Foreign adverse event report (initial) |
The application enables the check box with "■" when value for Foreign adverse event report (initial), J.4.a <mhlwadmicsrcasenumclass> tag is either 4 or 11, and J.5 < mhlwadmicsrmhlwcumreporttimes> is 1. |
|
103 |
外国副作用報告（追加報告） |
Foreign adverse event report (follow-up) |
The application enables the check box with "■" when value for Foreign adverse event report, J.4.a <mhlwadmicsrcasenumclass> tag is either 4 or 11, and J.5 < mhlwadmicsrmhlwcumreporttimes> is greater than 1. |
|
104 |
国内・外国感染症報告 |
Local/foreign infection report |
The application enables the check box with "■" when value for Local/foreign infection report, J.4.a <mhlwadmicsrcasenumclass> tag is 1, 3, 8, or 10. |
|
105 |
研究報告（医薬品、医薬部外品及び化粧品） |
Study report (drugs, medicated cosmetics, and cosmetics) |
The application enables the check box with "■" when value for study report, J.4.a <mhlwadmicsrcasenumclass> tag is 5, 6, 12, or 13. |
|
106 |
外国措置報告 |
Foreign measure report |
The application enables the check box with "■" when value for Foreign measure report, J.4.a <mhlwadmicsrcasenumclass> tag is 7 or 14. |
|
107 |
取り下げ報告 |
Nullification report |
The application enables the check box with "■" when value for nullification, A.1.13 < casenullification> tag is 1. |
|
108 |
再提出 |
Re-submission |
Run time field must be available to classify the report type. |
|
109 |
付属資料（添付資料を含む） |
Attached document |
Run time field must be available to classify the report type. |
|
110 |
返送日 |
Received date |
This field is left blank. |
|
111 |
送付日 |
Report date |
The application prints the system date at the time of generating report. |
|
112 |
企業名（企業略名） |
Company name (Company abbreviation) |
The application prints the company name if A.3.1.2 <senderorganization> is available, and prints the company abbreviation M.1.5 <messagesenderidentifier> in brackets. |
|
113 |
担当部門・担当者 |
Department/contact person |
The application prints department and user name of the logged in user from User maintenance. Run time field is provided to edit the information. Note: The Department Name must be printed followed by the contact person. |
|
114 |
連絡先電話番号 |
Phone number |
The application prints the department and user name of the logged in user from the User maintenance. Run time field must be provided to edit the information. |
|
115 |
整理番号 |
Reference number |
The reference number is provided by MHLW, when the report is first submitted to the authorities. The reference number must be entered for each case. |
|
116 |
性別 |
Sex |
The application prints the type of sex if B.1.5 < patientsex>and Prints "不明"(unknown) if B.1.5 < patientsex> is NULL. |
|
117 |
年齢 |
Age |
The application prints the age if B.1.2.2.a <patientonsetage> and B.1.2.2.b <patientonsetageunit> in literal as entered in ARISj. If B.1.2.2.a<patientonsetage> is not available, then the application prints B.1.2.3<patientagegroup>. |
|
118 |
医薬品名 |
Drug name |
The application prints the drug name if B.4.k.2.1 < medicinalproduct > is available. |
|
119 |
副作用名 |
ADR |
The application prints B.2.i. 0 <primarysourcereaction>. |
|
120 |
ファイル名・フォルダ名（資料名） |
File/folder name |
The application prints the Zip file name as .zip. |
|
121 |
識別番号 |
Identification number |
The application prints the Identification number, if J.4.b < mhlwadmicsrcasenumb > is available. |