Individual Case Safety Reporting (ICSR) Terminology Files

The NCIt-ICSR terminology files provided here support the cooperative efforts of the Food and Drug Administration (FDA) and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review of Individual Case Safety Reporting data. The efforts are described more fully on the Individual Case Safety Reports web page.

ICSR terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/ICSR/) in two formats:

FDA-ICSR_NCIt_Subsets.xls (Microsoft Excel 2003)*
FDA-ICSR_NCIt_Subsets.txt (Tab-delimited text)
FDA-ICSR_NCIt_US_Counties.xls (Microsoft Excel 2003)*
FDA-ICSR_NCIt_US_Counties.txt (Tab-delimited text)

Each file has column headers on the first row:

Spreadsheet Column Content Description

Source The initials of the requesting agency, in this case, the FDA.

Subset Code The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.

Subset Name The name of the subset.

Concept Code The NCIt concept code attached to the PT concept.

Source PT The preferred term chosen by the FDA attached to the concept.

Source Definition A text definition of the term created by an FDA subject matter expert.

Source Synonym(s) Terms chosen by the FDA that are synonomous to the Preferred Term.

ICSR terminology is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.

Subset Name Subset Description

Individual Case Safety Report Terminology All ICSR terms belong to this subset.

Adverse Event Outcome ICSR Terminology Terminology used in individual case safety reports for description of adverse event outcomes, section B2 of FDA MedWatch Form.

Device Usage ICSR Terminology Terminology used in individual case safety reports to specify a type of device usage, section H8 of FDA MedWatch Form.

Dose Denominator Qualifier ICSR Terminology Terminology used in individual case safety reports for description of the recipient of a dose.

Location of Event Occurence ICSR Terminology Terminology used in individual case safety reports to specify information on a location where event occurred, section F12 of FDA MedWatch Form.

Observation ICSR Terminology Terminology used in individual case reports for observations related to reporting adverse events.

Occupation ICSR Terminology Terminology used in individual case safety reports to specify information on an occupation of reporter, section E3 of FDA MedWatch Form.

Operator of Medical Device ICSR Terminology Terminology used in individual case safety reports to specify information on an operator of medical device, section D5 of FDA MedWatch Form.

Reason for Non-Evaluation ICSR Terminology Terminology used in individual case safety reports to specify a reason for non-evaluation of problematic medical product, section F3.3 of FDA MedWatch Form.

Report Source ICSR Terminology Terminology used in individual case safety reports to specify information on a report source, section G3 of FDA MedWatch Form.

Type of Event ICSR Terminology Terminology used in individual case safety reports for identifying type of event (adverse event or product problem), section B1 of FDA MedWatch Form.

Type of Follow-Up ICSR Terminology Terminology used in individual case safety reports to specify a type of follow-up after an initial report has been submitted, section H2 of FDA MedWatch Form.

Type of Manufacturer ICSR Terminology Terminology used in individual case safety reports to specify a type of medical product manufacturer.

Type of Remedial Action ICSR Terminology Terminology used in individual case safety reports to specify a type of remedial action after an adverse event occurs, section H7 of FDA MedWatch Form.

Type of Report ICSR Terminology Terminology used in individual case safety reports to specify information on a report type, section G7 of FDA MedWatch Form.

Type of Reportable Event ICSR Terminology Terminology used in individual case safety reports to specify the type of reportable event, section H1 of FDA MedWatch Form.

Type of Reporter ICSR Terminology Terminology used in individual case safety reports to specify a type of reporter.

Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/ICSR/) are the following additional files:

About (This file)
Changes.txt (A text file of changes between the most recent and the current version of ICSR terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.)
Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 11.02d which corresponds to the year 2011, the month of February, and the "d" refers to the fourth Monday of the month.)

N.B.: If there are no changes to the data for a particular month, the files will not be reposted. An update via the LISTSERV will be sent with this information. An NCI EVS ICSR Data Terminology LISTSERV has been created for end users' questions and for update notifications. Please visit the following link to sign up for the LISTSERV and search for ncievs-icsr-terms-L .

Archived files are available at:

Archive/ Directory of dated release versions.

Help requests on these files should go to NCIThesaurus@mail.nih.gov

* If an attempt to view the Excel spreadsheet results in a page of nonsense characters, check the security settings in Excel to permit viewing. This is achievable by clicking the highlighted bar above the data, but below the menu bar in the spreadsheet.

Spreadsheet Column	Content Description
Source	The initials of the requesting agency, in this case, the FDA.
Subset Code	The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
Subset Name	The name of the subset.
Concept Code	The NCIt concept code attached to the PT concept.
Source PT	The preferred term chosen by the FDA attached to the concept.
Source Definition	A text definition of the term created by an FDA subject matter expert.
Source Synonym(s)	Terms chosen by the FDA that are synonomous to the Preferred Term.

Subset Name	Subset Description
Individual Case Safety Report Terminology	All ICSR terms belong to this subset.
Adverse Event Outcome ICSR Terminology	Terminology used in individual case safety reports for description of adverse event outcomes, section B2 of FDA MedWatch Form.
Device Usage ICSR Terminology	Terminology used in individual case safety reports to specify a type of device usage, section H8 of FDA MedWatch Form.
Dose Denominator Qualifier ICSR Terminology	Terminology used in individual case safety reports for description of the recipient of a dose.
Location of Event Occurence ICSR Terminology	Terminology used in individual case safety reports to specify information on a location where event occurred, section F12 of FDA MedWatch Form.
Observation ICSR Terminology	Terminology used in individual case reports for observations related to reporting adverse events.
Occupation ICSR Terminology	Terminology used in individual case safety reports to specify information on an occupation of reporter, section E3 of FDA MedWatch Form.
Operator of Medical Device ICSR Terminology	Terminology used in individual case safety reports to specify information on an operator of medical device, section D5 of FDA MedWatch Form.
Reason for Non-Evaluation ICSR Terminology	Terminology used in individual case safety reports to specify a reason for non-evaluation of problematic medical product, section F3.3 of FDA MedWatch Form.
Report Source ICSR Terminology	Terminology used in individual case safety reports to specify information on a report source, section G3 of FDA MedWatch Form.
Type of Event ICSR Terminology	Terminology used in individual case safety reports for identifying type of event (adverse event or product problem), section B1 of FDA MedWatch Form.
Type of Follow-Up ICSR Terminology	Terminology used in individual case safety reports to specify a type of follow-up after an initial report has been submitted, section H2 of FDA MedWatch Form.
Type of Manufacturer ICSR Terminology	Terminology used in individual case safety reports to specify a type of medical product manufacturer.
Type of Remedial Action ICSR Terminology	Terminology used in individual case safety reports to specify a type of remedial action after an adverse event occurs, section H7 of FDA MedWatch Form.
Type of Report ICSR Terminology	Terminology used in individual case safety reports to specify information on a report type, section G7 of FDA MedWatch Form.
Type of Reportable Event ICSR Terminology	Terminology used in individual case safety reports to specify the type of reportable event, section H1 of FDA MedWatch Form.
Type of Reporter ICSR Terminology	Terminology used in individual case safety reports to specify a type of reporter.