CIOMS Line Listing Report Selection

The CIOMS (Council for International Organization of Medical Sciences) Line Listing Report is a general-purpose regulatory report used to report to the various authorities about the drugs and details corresponding to reactions. This report is generated in the language set by the user in the User Preferences option.

Select Reports-> CIOMS Line Listing to display CIOMS Line Listing Selection page.

CIOMS Line Listing Report - Selection Tab

Field Name	Description
AER no. range From to	The range of AERs to consider for generating the report. Enter the AER number range.
WHO DD	The WHO DD to be considered while generating the report from the associated lookup. All the AERs containing the selected WHO DD are considered while generating the report.
Product description	The product to be considered while generating the report from the associated lookup. All AERs containing the selected product name are considered while generating the report.
Use PPD code	Select the check box to generate the CIOMS report for a specific trade name along with its PPD code as a product’s PPD code does not change with the change in its trade name.
Approval No.	The approval number of the drug.
Type	The approval type of the drug.
Country	The country that has approved the drug.
Admin Route	The route of administration of the drug.
Form	The form of administration of the drug.
Protocol no.	The Protocol and Project number. You can also click the lookup icon and select the protocol details from the lookup window. The details you select would be displayed in this ''Protocol no.” and ''Project no.” fields.
Project no.
Date range: From to	The date range considered for generating the report. All the AERs in the specified range are considered for generating the report.
Unrelated cases	'Yes’ will include unrelated cases in the report. 'No’ will omit unrelated cases. By default, 'Yes’ is marked.
SOC/Body system code from	Indicate from where the body system is taken. Select the appropriate radio button. The options are: From the AER From the Dictionary. By default, the Body system is taken from the AER.
Case type	Required type of cases considered when generating the report. Select the appropriate radio button. Serious Non serious Both By default, Both are marked.
Labeling	Include labeled cases only. This includes only the labeled cases when generating the report. Include both labeled and unlabeled cases will include both the labeled and unlabeled cases when generating the report. By default, Include both labeled and unlabeled cases are marked.
Country of labeling	The country that has labeled the drug.
Mark solicited cases	To mark solicited cases in the report. Yes - Solicited cases included in the report are marked with the symbol '%’ (Percentage), and the footnote '%: Solicited Report’ is printed along with the Report Footer text. No (Default) - Solicited cases are not marked in the report.
Mark if reported	Specifies if the AERs reported to a specific authority are to be marked with an asterisk (). The option 'Yes’ prefixes the AER number with a '’ when that AER is reported to the authority defined in User Preferences for CIOMS reports. The option 'No’ leaves all AER numbers unmarked, irrespective of reporting status. By default, 'No’ is marked.
Print selection	Defines if the report selection criteria are printed on the report. The option 'Yes’ prints the report selection criteria on the report. The option 'No’ does not print the report selection criteria. By default, 'Yes’ is marked.
Dose no. in series	The dose number in the series, if the product is a vaccine. Choose the appropriate option.
Print only rank 1 reaction	Selecting ’Yes’ prints only Rank 1 reaction. Selecting 'No’ prints all the reactions.
Include unapproved cases	To include unapproved cases also in the line listing report. Yes - In this case, the installation parameter 'Include only approved AERs in line listing reports?’ is not considered and only unapproved cases are included in the report. No - Only approved cases are included in the report.
Ignore not relevant	To print the records that are marked as ''not relevant”.

CIOMS Line Listing Report - Blinding Support Tab

Field Name	Description
Report type
Blinded	To print the Blinded information of the case in the report generated. This option is selected by default.
Unblinded	To print the Unblinded information of the case in the report generated.

Field Name	Description
For unblinded report This option appears only when you select the Unblinded option.
If no access to unblinded data The options, Print blinded info and Do not include case are applicable only for unprivileged users.
Print blinded info.	To print blinded information in unblinded report. This option is selected by default. AER Number contains the ''#”symbol, when you print the blinded product information in the unblinded report. The footer of the unblinded report prints ''#: Blinded product information printed”.
Do not include case	When you do not have privileges for a case and if you select the checkbox, the application restricts you from printing the unblinded cases in the report. The application prints an empty report, when you do not select any data. Select the checkbox, to print Blinded records and Normal records in the report.
Blinded cases
Prevent blinded cases	To prevent blinded cases from being printed in the Unblinded reports. The available options are: Do not select ''Prevent blinded cases” check box to print blinded and normal records of the case in unblinded reports. This option is applicable for privileged and unprivileged users. AER Number contains the ''~”symbol, when you print blinded product information in the unblinded report. The footer of unblinded report prints ''~: Blinded case”.

CIOMS Line Listing Report - Layout Tab

Field Name	Description
Group on	To group the AEs. (Body system, Drug name (Product description or active ingredient), Route of Administration, Seriousness, Labeling, Form of administration).
Sort on	To sort the AEs. Country of occurrence AER Number or Reaction term (Reported term, Preferred term, and Included term). By default, AER Number is marked.
Page title	The details of the Page title (title to appear on the cover page of the report) in the space provided.
Page footer	The details of the Page footer (footer of each page) in the space provided.
Report footer	The details of the Report footer (footer of the report) in the space provided.