ICSR business rules
The alphanumeric character limits, codes and formatting rules for each field must be adhered to, as specified in the A.1 ICSR Attribute List of the ICH ICSR DTD to ensure transmission of the reports.
Where dates are provided, the date should be on or before the transmission date. Future dates must not be used.
M.1 ICH ICSR message header specifications
A Safety Message sent to the TGA must may contain only one ICSR. The ICSR contains a Message Header part which should include information on the sender, the receiver, the message date and a unique message identification number.
A. E2B (R2) ICSR specifications
Section A provides information on the following aspects of the ICSR:
- A.1 Safety report
- A.2 Primary source(s) of information
- A.3 Information on sender and receiver of ISCR.
B. Information on the case
Section B provides the following information on the adverse event:
- B.1 Patient characteristics
- B.2 Reaction(s) or event(s)
- B.3 Results of tests and procedures relevant to the investigation of the patient
- B.4 Drug(s) information
- B.5 Narrative case summary and further information.
In this section: Use of dates and intervals | B.1.7 Relevant medical history and concurrent conditions | B.1.8 Relevant past drug history | B.2 Reaction(s) or event(s) | B.3 Results of tests and procedures relevant to the investigation of the patient | B.4 Drug(s) information
Use of dates and intervals
When specifying the duration relating to an adverse event, the preferred format is for dates to be transmitted in the appropriate items, rather than intervals.
Intervals may be used where only imprecise dates are known but more information concerning the interval is known. For example, where there is a very short interval between drug administration and start of reaction or event, such as in anaphylaxis.
Dates specified in ICSRs cannot refer to a future date. Any future dates will generate an error message during validation.
B.1.7 Relevant medical history and concurrent conditions
Medical judgment should be exercised in completing this section. Information pertinent to understanding the case is desired, such as diseases, conditions such as pregnancy, surgical procedures, and psychological trauma. Each of the items in the section can be repeated as appropriate.
Information can be included as comments if precise dates are unknown and a text description would aid in understanding the medical history, or if concise additional information is helpful in showing the relevance of the past medical history.
B.1.8 Relevant past drug history
This section concerns drugs previously taken, but not those taken concomitantly or drugs that may have potentially been involved in the current reaction or event. Information concerning concomitant and other suspect drugs should be included in section B.4.
The information provided in B.1.8 can also include previous experience with similar drugs. Medical judgment should be exercised in completing this section.
B.2 Reaction(s) or event(s)
The designation of i in this section indicates that each item is repeatable and that it carries an appropriate correspondence to the same i in all subsections. A separate block (i) should be used for each reaction or event term. For example, if two reactions are observed, the first reaction would be described in items B.2.1.0 through B.2.1.8, and the other reaction would be described in items B.2.2.0 through B.2.2.8. The reaction or event specified in the first iteration should be the one used in assessing the intervals in B.4.k.13.
B.3 Results of tests and procedures relevant to the investigation of the patient
This section should capture the tests and procedures performed to diagnose or confirm the reaction or event, including those tests done to investigate (exclude) a nondrug cause, (for example, serologic tests for infectious hepatitis in suspected drug-induced hepatitis). Both positive and negative results should be reported where known. Although structured information is preferable, provisions have been made to transmit the information as free text in B.3.2.
B.4 Drug(s) information
This section covers both suspect drugs (including all interacting drugs) and concomitant medications, including vaccines. For each drug, the characterisation of the drug role (B.4.k.1) is that indicated by the primary reporter (the original source of the information).
The designation k in this section indicates that each item is repeatable and that it carries an appropriate correspondence to the same k in all subsections. A separate block (k) should be used for each drug. The drug specified in the first iteration should be the one used in assessing the intervals in data element B.2.i.7. Drugs used to treat the reaction or event should not be included in section B.4.
The Australian approved name should be provided where possible but if unavailable the substance name/s should be provided. In the case of investigational drugs, only a code may be known and provided. For clinical trials involving a product included in the ARTG, the Australian Approved Name should be provided.
If a single drug contains multiple active substances, each should be specified as a repeating data element B.4.k.2.2.
B.4.k.5 Structured dosage information
Table 1 provides examples for completing data elements B.4.k.5.1 through B.4.k.5.7.
The cumulative dose provided is the total dose administered until the first sign, symptom, or reaction. For prolonged chronic therapy, the sender should consider the need to complete the cumulative dose data elements.
In the case of a parent-child or parent-foetus report, the dosage data elements apply to the parental dose.
For dosage regimens that involve more than one dosage form and/or changes in dosage, the information can be provided in data element B.4.k.6 as text. Alternatively, the sender can provide more than one iteration (k) for the same drug.
2 mg three times a day for five days
5 mg (in one dose) every other day for 30 days
50 mg daily for 2 days
|B.4.k.5.1 dose (number)||2||5||50|
|B.4.k.5.2 dose (unit)||mg||mg||mg|
|B.4.k.5.3 number of separate dosages||3||1||1|
|B.4.k.5.4 number of units in the interval||1||2||1|
|B.4.k.5.5 definition of the interval unit||day||day||day|
|B.4.k.5.6 cumulative dose to first reaction (number)||30||75||100|
|B.4.k.5.7 cumulative dose to first reaction (unit)||mg||mg||mg|
B.4.k.18 Relatedness of drug to reactions or events
This repeatable block provides the means to transmit the degree of suspected relatedness of each drug to the reaction or event. The repeating elements could also be used to provide the assessment of relatedness by different sources or methods of assessment. For the purpose of reporting, there is an implied suspicion of causality for spontaneous reports. It is recognised that information concerning the relatedness, especially for spontaneous reports, is often subjective and may not be available.
Example of extensive functionality
The following example illustrates the extensive functionality contained in this section:
- A patient was being treated with two medications: Drug A and Drug B.
- The patient had two adverse events: Event 1 and, Event 2
- The reporter provided assessment of causality for event 1 for both Drug A and Drug B, but not for event 2 for either drug. The reporter's assessment of causality is based on overall impression, which the sender codes as "global introspection".
- The sender applied causality assessment with an algorithm (coded algorithm), but it does so only for the drug it manufactures (in this case Drug A) for both reported events.
- Therefore, there are 2 sets of data for the reporter (2 drug x1 events x1 method of assessment) and 2 sets for the sender (1 drug x2 events x1 method of assessment) for a total 4 sets of data.
- The appropriate data element for the information is B.4.k.18 (and its four subfields 1-4) as shown in table 2. In this example k is replaced by Drug A and Drug B respectively. Please note the subfields 1-4 are repeatable.
|k(1) = Drug A|
|k(2) = DRUG B|
|Event1||Reporter||global introspection||not related|
The order of the rows is not important since each one represents a complete set, however the E2B message and M2 specifications state that all assessments for Drug A (k=1) appear before Drug B (k=2).