M.1 ICH ICSR message header specifications
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| M.1.1 | messagetype | Yes | All ICSRs must be 'ichicsr', including reports from clinical trials. | If validation fails for any of M.1 data elements, the error message returned will be: <DTD Descriptor>: 'The incoming message has failed batch validation. Please refer to the TGA EDI ICSR R2 Implementation Guidelines'. | |
| M.1.2 | messageformatversion | No | |||
| M.1.3 | messageformatrelease | No | |||
| M.1.4 | messagenumb | Yes | |||
| M.1.5 | messagesenderidentifier | Yes | |||
| M.1.6 | messagereceiveridentifier | Yes | |||
| M.1.7a | messagedateformat | Yes | |||
| M.1.7b | messagedate | Yes | The date specified cannot refer to a future date. |
|
ICH ICSR M2 data processing specifications
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| safetyreportversion | Yes |
| Default error message. If validation fails, the following error message is returned: <safetyreportid>: Invalid data supplied. The ICSR version number has been previously submitted. |
A. E2B (R2) ICSR specifications
A.1 Safety report
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules and notes | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| A.1.0.1 | safetyreportid | Yes |
|
|
|
| A.1.1 | primarysourcecountry | No | This should correspond to one of the primary source countries reported in A.2.1.3. | Default error message. | |
| A.1.2 | occurcountry | No | Include if different from A.1.1 | Default error message. | |
| A.1.3a | transmissiondateformat | Yes | Default error message. | ||
| A.1.3b | transmissiondate | Yes | The date specified cannot refer to a future date. | Default error message. | |
| A.1.4 | reporttype | Yes | If A.2.3.3 is provided against the 1st primary source record, this field must be provided with a value of '2'. | Default error message. | |
| A.1.5.1 | serious | Yes | If any of the A.1.5.2 fields are set to 1 (Yes), then A.1.5.1 must be '1' (Yes). | If any of the reactions or events in the case is serious, the serious flag is to be set to Yes. | Default error message. |
| A.1.5.2 | seriousnessdeath | Yes | If A.1.5.1 is '1' (yes), at least one of the A.1.5.2 fields must be '1' (yes). The A.1.5.2 data elements which are not set to '1' (yes) can either be set to '2' (no) or left as null/absent. | Default error message. | |
| seriousnesslifethreatening | Yes | Life threatening is defined in the ICH E2A | |||
| seriousnesshospitalization | Yes | ||||
| seriousnessdisabling | Yes | ||||
| seriousnesscongenitalanomali | Yes | ||||
| seriousnessother | Yes | Other means medically important condition as defined in ICH E2A | |||
| A.1.6a | receivedateformat | Yes | Default error message. | ||
| A.1.6b | receivedate | Yes | The date specified cannot refer to a future date. | Default error message. | |
| A.1.7a | receiptdateformat | Yes | Default error message. | ||
| A.1.7b | receiptdate | Yes | The date specified cannot refer to a future date. | Default error message. | |
| A.1.8.1 | additionaldocument | Conditional | If A.1.8.2 is provided, A.1.8.1 must be '1' (Yes). | Default error message. | |
| A.1.8.2 | documentlist | Conditional | A.1.8.2 must be provided if A.1.8.1 is '1' (Yes). | Default error message. | |
| A.1.9 | fulfillexpeditecriteria | No | Default error message. | ||
| A.1.10.1 | authoritynumb | Conditional | Either A.10.1 or A.1.10.2 must be provided. | Default error message. | |
| A.1.10.2 | companynumb | Conditional | |||
| A.1.11 | duplicate | Conditional | If A.1.11.1 and A.1.11.2 are provided, A.1.11 must be provided with a value of '1' (Yes). | Default error message. | |
| A.1.11.1 | duplicatesource | Conditional | If A.1.11 is '1' (Yes), A.1.11.1 must be provided. If A.1.11.2 is provided, A.1.11.1 must be provided. | Details from previous transmissions of the same case from either other senders or by the same sender using a different reporting channel such as email or online form should be provided in this section. | Default error message. |
| A.1.11.2 | duplicatenumb | Conditional | If A.1.11 is '1' (Yes), A.1.11.2 must be provided. If A.1.11.1 is provided, A.1.11.2 must be provided. | Default error message. | |
| A.1.12 | linkreportnumb | No | This field identifies reports or cases that warrant being evaluated together. For example, a sequence of cases involving the same patient. | Default error message. | |
| A.1.13 | casenullification | Conditional | If provided, must be '1' (Yes). If A.1.13.1 is provided, A.1.13 must be provided with value '1' (Yes). | This section indicates that a previous report should be considered void (nullified). To resubmit reports that have previously been nullified, assign a new safetyreportid. | Default error message. |
| A.1.13.1 | nullificationreason | Conditional | When A.1.13 is '1' (Yes), A.1.13.1 must be provided | Default error message. | |
| A.1.14 | medicallyconfirm | No | Default error message. |
A.2 Primary source(s) of information
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| A.2 | primarysource | Yes | At least one of the data elements in section A.2.1 must be supplied in the message (excluding A.2.1.1 elements). | Default error message. | |
| A.2.1.1a | reportertitle | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.2.1.1.b | reportergivename | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.2.1.1c | reportermiddlename | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.2.1.1d | reporterfamilyname | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.2.1.2a | reporterorganization | Conditional | Default error message. | ||
| A.2.1.2b | reporterdepartment | Conditional | Default error message. | ||
| A.2.1.2c | reporterstreet | Conditional | If A.2.1.4 does not equal '5', this element will be stored by the TGA as Masked. | The TGA does not collect this element for consumers and non-health professionals. | Default error message. |
| A.2.1.2d | reportercity | Conditional | If A.2.1.4 does not equal '5', this element will be stored by the TGA as Masked. | The TGA does not collect this element for consumers and non-health professionals. | Default error message. |
| A.2.1.2e | reporterstate | Conditional | Default error message. | ||
| A.2.1.2f | reporterpostcode | Conditional | If A.2.1.4 does not equal '5', this element will be stored by the TGA as Masked. | The TGA does not collect this element for consumers and non-health professionals. | Default error message. |
| A.2.1.3 | reportercountry | Conditional | Default error message. | ||
| A.2.1.4 | qualification | Conditional | Default error message. | ||
| A.2.2 | Literaturereference | No | References are to be provided in the Vancouver Convention. | Default error message. | |
| A.2.3.1 | studyname | No | Default error message. | ||
| A.2.3.2 | sponsorstudynumb | No | Default error message. | ||
| A.2.3.3 | observestudytype | Conditional | If A.1.4 is'2', A.2.3.3 must be provided for the 1st primary source record (Report from Study). | Default error message. |
A.3 Information on sender and receiver of ISCR
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| A.3.1.1 | sendertype | No | Sender Type should be provided but when it is not provided it will default to unknown. | Default error message. | |
| A.3.1.2 | senderorganization | Yes | Default error message. | ||
| A.3.1.3a | senderdepartment | No | Default error message. | ||
| A.3.1.3b | sendertitle | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.3.1.3c | sendergivename | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.3.1.3d | sendermiddlename | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.3.1.3e | senderfamilyname | No | If provided, this element will be stored by the TGA as Masked. | You do not need to provide this element. | Default error message. |
| A.3.1.4a | senderstreetaddress | No | Default error message. | ||
| A.3.1.4b | sendercity | No | Default error message. | ||
| A.3.1.4c | senderstate | No | Default error message. | ||
| A.3.1.4d | senderpostcode | No | Default error message. | ||
| A.3.1.4e | sendercountrycode | No | Default error message. | ||
| A.3.1.4f | sendertel | No | Default error message. | ||
| A.3.1.4g | sendertelextension | No | Default error message. | ||
| A.3.1.4h | sendertelcountrycode | No | Default error message. | ||
| A.3.1.4i | senderfax | No | Default error message. | ||
| A.3.1.4j | senderfaxextension | No | Default error message. | ||
| A.3.1.4k | senderfaxcountrycode | No | Default error message. | ||
| A.3.1.4l | senderemailaddress | No | An email address should be provided. This email address may be used when sending correspondence to Sender. | Default error message. | |
| A.3.2.1 | receivertype | No | Where provided it should be set to a value of '2' Regulatory Authority | Default error message. | |
| A.3.2.2a | receiverorganization | No | Where provided it should be set to 'TGA' | Default error message. | |
| A.3.2.2b | receiverdepartment | No | Where provided it should be set to 'Pharmacovigilance and Special Access Branch' | Default error message. | |
| A.3.2.2c | receivertitle | No | Default error message. | ||
| A.3.2.2d | receivergivename | No | Default error message. | ||
| A.3.2.2e | receivermiddlename | No | Default error message. | ||
| A.3.2.2f | receiverfamilyname | No | Default error message. | ||
| A.3.2.3a | receiverstreetaddress | No | Where provided it should be set to 'PO Box 100' | Default error message. | |
| A.3.2.3b | receivercity | No | Where provided it should be set to 'Woden' | Default error message. | |
| A.3.2.3c | receiverstate | No | Where provided it should be set to 'ACT' | Default error message. | |
| A.3.2.3d | receiverpostcode | No | Where provided it should be set to '2606' | Default error message. | |
| A.3.2.3e | receivercountrycode | No | Where provided it should be set to 'AU' | Default error message. | |
| A.3.2.3f | receivertel | No | Default error message. | ||
| A.3.2.3g | receivertelextension | No | Where provided it should be set to '262216963' | Default error message. | |
| A.3.2.3h | receivertelcountrycode | No | Where provided it should be set to '+61' | Default error message. | |
| A.3.2.3i | receiverfax | No | Default error message. | ||
| A.3.2.3j | receiverfaxextension | No | Where provided it should be set to '262031713' | Default error message. | |
| A.3.2.3k | receiverfaxcountrycode | No | Where provided it should be set to '+61' | Default error message. | |
| A.3.2.3l | receiveremailaddress | No | Where provided it should be set to 'adr.reports@tga.gov.au' | Default error message. |
B. Information on the case
B.1 Patient characteristics
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.1 | patient | Yes | At least one of the following must be provided:
| Default error message. | |
| B.1.1 | patientinitial | Conditional | Where the data is known but cannot be provided this element can be set to PRIVACY or MSK. Where you believe there is a real patient involved but do not have any specific patient characteristics available, this element can be set to UNK. | Default error message. | |
| B.1.1.1a | patientgpmedicalrecordnumb | Conditional | Default error message. | ||
| B.1.1.1b | patientspecialistrecordnumb | Conditional | Default error message. | ||
| B.1.1.1c | patienthospitalrecordnumb | Conditional | Default error message. | ||
| B.1.1.1d | patientinvestigationnumb | Conditional | Default error message. | ||
| B.1.2 | Age information | Only one element describing age should be provided, based on the most precise information available. | Default error message. | ||
| B.1.2.1a | patientdatebirthformat | Conditional | If B.1.2.1b is provided, B.1.2.1a b must be provided. | Default error message. | |
| B.1.2.1b | patientdatebirth | Conditional | Where B.1.2.1a is provided, B.1.2.1b must be provided. | Default error message. | |
| B.1.2.2a | patientonsetage | Conditional | Where B.1.2.2a is provided, B.1.2.2b must be provided. Age must be less than or equal to 120 years. | If several reactions or events are in the case, the age at the time of the first reaction or event should be used. | Default error message. |
| B.1.2.2b | patientonsetageunit | Conditional | Where B.1.2.2b is provided, B.1.2.2a must be provided. | Default error message. | |
| B.1.2.2.1a | gestationperiod | Conditional | Where B.1.2.2.1a is provided, B.1.2.2.1b must be provided. | Default error message. | |
| B.1.2.2.1b | gestationperiodunit | Conditional | Where B.1.2.2.1b is provided, B.1.2.2.1a must be provided. | Default error message. | |
| B.1.2.3 | patientagegroup | Conditional | Default error message. | ||
| B.1.3 | patientweight | No | Weight must be less than or equal to 500kg. Up to 4 decimal places are allowed and this is included in the character limit. | Default error message. | |
| B.1.4 | patientheight | No | Height must be less than or equal to 300 cm. | Default error message. | |
| B.1.5 | patientsex | Conditional | If sex is unknown, intersex or indeterminate leave this data element blank. | Default error message. | |
| B.1.6a | lastmenstrualdateformat | Conditional | Where B.1.6b is provided, B.1.6a must be provided. | Default error message | |
| B.1.6b | patientlastmenstrualdate | Conditional | Where B.1.6a is provided, B.1.6b must be provided. The date specified cannot refer to a future date. | Default error message. |
B.1.7 Relevant medical history and concurrent conditions
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.1.7.1a.1 | patientepisodenamemeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.7.1a.2 | patientepisodename | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.7.1b | patientmedicalstartdateformat | Conditional | If B.1.7.1c is provided, B.1.7.1b must be provided. | Default error message. | |
| B.1.7.1c | patientmedicalstartdate | Conditional | Where B.1.7.1b is provided, B.1.7.1c must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.7.1d | patientmedicalcontinue | No | Default error message. | ||
| B.1.7.1e | patientmedicalenddateformat | Conditional | Where B.1.7.1f is provided, B.1.7.1e must be provided. | Default error message. | |
| B.1.7.1f | patientmedicalenddate | Conditional | Where B.1.7.1e is provided, B.1.7.1f must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.7.1g | patientmedicalcomment | No | Default error message. | ||
| B.1.7.2 | patientmedicalhistorytext | No | Default error message. |
B.1.8 Relevant past drug history
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.1.8a | patientdrugname | Conditional | If any of the following data elements in the patient block (B.1.8b+B.1.8c or B.1.8d+B.1.8e or B.1.8f.2 or B.1.8fg.2) are provided, B.1.8a must be provided. | Where possible provide the trade name of the product. | Default error message. |
| B.1.8b | patientdrugstartdateformat | Conditional | Where B.1.8c is provided, B.1.8 b must be provided. | Default error message. | |
| B.1.8c | patientdrugstartdate | Conditional | Where B.1.8b is provided, B.1.8c must be provided. | Default error message. | |
| B.1.8d | patientdrugenddateformat | Conditional | Where B.1.8e provided, B.1.8d must be provided. | Default error message. | |
| B.1.8e | patientdrugenddate | Conditional | Where B.1.8d provided, B.1.8e must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.8f.1 | patientindicationmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.8f.2 | patientdrugindication | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.8g.1 | patientdrgreactionmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.8g.2 | patientdrgreaction | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.9 | patientdeath | No | Default error message. | ||
| B.1.9.1a | patientdeathdateformat | Conditional | Where B.1.9.1b is provided, B.1.9.1a must be provided. | Default error message. | |
| B.1.9.1b | patientdeathdate | Conditional | Where B.1.9.1a is provided, B.1.9.1b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.9.2.a | patientdeathreportmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.9.2.b | patientdeathreport | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.9.3 | patientautopsyyesno | Conditional | If B.1.9.1b is provided, B.1.9.3 must be provided. If B.1.9.4b is provided, B.1.9.3must be '1' (Yes). | Default error message. | |
| B.1.9.4a | patientdetermautopsmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.9.4b | patientdetermineautopsy | Conditional | Where B.1.9.4b provided, B.1.9.3 must be = '1' (Yes). | Default error message. |
B.1.10 For a parent-child/foetus report, Information concerning the parent
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.1.10.1 | parentidentification | No | Default error message. | ||
| B.1.10.2.1a | parentbirthdateformat | Conditional | Where B.1.10.2.1b is provided, B.1.10.2.1a must be provided. | Only one element describing age should be used, based on the most precise information available. | Default error message. |
| B.1.10.2.1b | parentbirthdate | Conditional | If B.1.10.2.1a provided, B.1.10.2.1b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.2.2a | parentage | Conditional | If B.1.10.2.2a is provided, B.1.10.2.2b must be supplied. Age must be less than or equal to 120 years. | Default error message. | |
| B.1.10.2.2b | parentageunit | Conditional | If B.1.10.2.2b is provided, B.1.10.2.2a must be supplied. | Default error message. | |
| B.1.10.3a | parentlastmenstrualdateformat | Conditional | Where B.1.10.3b is provided, B.1.10.3a must be provided. | Default error message. | |
| B.1.10.3b | parentlastmenstrualdate | Conditional | Where B.1.10.3a provided, B.1.10.3b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.4 | parentweight | No | Weight must be less than or equal to 500kg. Up to 3 decimal places are allowed and this is included in the character limit. | Default error message. | |
| B.1.10.5 | parentheight | No | Where provided height must be less than or equal to 300 cm. | Default error message. | |
| B.1.10.6 | parentsex | No | Default error message. | ||
| B.1.10.7.1a.1 | parentmdepisodemeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.10.7.1a.2 | parentmedicalepisodename | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.10.7.1b | parentmedicalstartdateformat | Conditional | Where B.1.10.7.1c is provided, B.1.10.7.1b must be provided. | Default error message. | |
| B.1.10.7.1c | parentmedicalstartdate | Conditional | Where B.1.10.7.1b is provided, B.1.10.7.1c must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.7.1d | parentmedicalcontinue | No | Default error message. | ||
| B.1.10.7.1e | parentmedicalenddateformat | Conditional | Where B.1.10.7.1f is provided, B.1.10.7.1e must be provided. | Default error message. | |
| B.1.10.7.1f | parentmedicalenddate | Conditional | Where B.1.10.7.1e is provided, B.1.10.7.1f must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.7.1g | parentmedicalcomment | No | Default error message. | ||
| B.1.10.7.2 | parentmedicalrelevanttext | No | Default error message. | ||
| B.1.10.8a | parentdrugname | Conditional | If any of the following fields in the parent block (B.1.10.8b and B.1.10.8c or B.1.10.8d and B.1.10.8e or B.1.10.8f.2 or B.1.10.8g.2) are provided, B.1.10.8a must be provided | Where possible provide the trade name of the product. | Default error message. |
| B.1.10.8b | parentdrugstartdateformat | Conditional | If B.1.10.8c provided, B.1.10.8b must be provided. | Default error message. | |
| B.1.10.8c | parentdrugstartdate | Conditional | Where B.1.10.8b provided, B.1.10.8c must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.8d | parentdrugenddateformat | Conditional | Where B.1.10.8e is provided, B.1.10.8d must be provided. | Default error message. | |
| B.1.10.8e | parentdrugenddate | Conditional | Where B.1.10.8d is provided, B.1.10.8e must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.1.10.8f.1 | parentdrgindicationmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.10.8f.2 | parentdrugindication | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.1.10.8g.1 | parentdrgreactionmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.1.10.8g.2 | parentdrugreaction | No | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
B.2 Reaction(s) or event(s)
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.2.i.0 | primarysourcereaction | No | Default error message. | ||
| B.2.i.1.a | reactionmeddraversionllt | Yes | A decimal point/full stop is allowed. For example, 19.1. | Only one MedDRA version may be used in ICSR's received through the EDI. The first instance of the MedDRA version populated in B.2.i.1.a will be used for validation of all other MedDRA version data elements in the ICSR. | Default error message. |
| B.2.i.1.b | reactionmeddrallt | Yes | Must match either an 8 digit MedDRA code or text for a Low Level Term. | Where possible, use the 8 digit MedDRA code for a Low Level Term rather than the text for the LLT. | Default error message. |
| B.2.i.2.a | reactionmeddraversionpt | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.2.i.2.b | reactionmeddrapt | No | Default error message. | ||
| B.2.i.3 | termhighlighted | No | If the information is not explicitly provided by the initial reporter, the term should not be considered a highlighted term. The seriousness of the reaction or event should be based on the ICH E2A criteria. | Default error message. | |
| B.2.i.4a | reactionstartdateformat | Conditional | Where B.2.i.4b is provided, B.2.i.4a must be provided. | Default error message. | |
| B.2.i.4b | reactionstartdate | Conditional | Where B.2.i.4a is provided, B.2.i.4b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.2.i.5a | reactionenddateformat | Conditional | Where B.2.i.5b is provided, B.2.i.5a must be provided. | Default error message. | |
| B.2.i.5b | reactionenddate | Conditional | Where B.2.i.5a is provided, B.2.i.5b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.2.i.6a | reactionduration | Conditional | Where B.2.i.6a is provided, B.2.i.6b must be provided. | Default error message. | |
| B.2.i.6b | reactiondurationunit | Conditional | Where B.2.i.6b is provided, B.2.i.6a must be provided. | Default error message. | |
| B.2.i.7.1a | reactionfirsttime | Conditional | Where B.2.i.7.1a is provided, B.2.i.7.1b must be provided. | Default error message. | |
| B.2.i.7.1b | reactionfirsttimeunit | Conditional | Where B.2.i.7.1b is provided, B.2.i.7.1a must be provided. | Default error message. | |
| B.2.i.7.2a | reactionlasttime | Conditional | Where B.2.i.7.2a is provided, B.2.i.7.2b must be provided. | Default error message. | |
| B.2.i.7.2b | reactionlasttimeunit | Conditional | Where B.2.i.7.2b is provided, B.2.i.7.2a must be provided. | Default error message. | |
| B.2.i.8 | reactionoutcome | No | Default error message. |
B.3 Results of tests and procedures relevant to the investigation of the patient
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledement response error messages |
|---|---|---|---|---|---|
| B.3.1a | testdateformat | Conditional | Where B.3.1b is provided, B.3.1a must be provided. | Default error message. | |
| B.3.1b | testdate | Conditional | If B.3.1a provided, B.3.1b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.3.1c | testname | Conditional | If B.3.1b provided, B.3.1c must be provided. | Default error message. | |
| B.3.1d | testresult | No | Test results should be reported where known. | Default error message. | |
| B.3.1e | testunit | No | Default error message. | ||
| B.3.1.1 | lowtestrange | No | Default error message. | ||
| B.3.1.2 | hightestrange | No | Default error message. | ||
| B.3.1.3 | moreinformation | No | Default error message. | ||
| B.3.2 | resultstestsprocedures | No | Default error message. |
B.4 Drug(s) information
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.4.k.1 | drugcharacterization | Yes | Each ICSR must contain at least one 'Suspect' or 'Interacting' drug. | Where 'Interacting' has been set for a product in the ICSR, information should be provided on the other product/s that were part of the interaction. | Default error message. |
| B.4.k.2.1 | medicinalproduct | Conditional | Either B.4.k.2.1 or B.4.k.2.2 must be provided. | Where possible provide the trade name of the product. | Default error message. |
| B.4.k.2.2 | activesubstancename | Conditional | Either B.4.k.2.1 or B.4.k.2.2 must be provided. | Default error message. | |
| B.4.k.2.3 | obtaindrugcountry | No | Default error message. | ||
| B.4.k.3 | drugbatchnumb | No | Default error message. | ||
| B.4.k.4.1 | drugauthorizationnumb | No | Where possible provide the Australian Register of Therapeutic Goods (ARTG) number of the product. | Default error message. | |
| B.4.k.4.2 | drugauthorizationcountry | Conditional | Where B.4.k.4.1 is provided, B.4.k.4.2 is required. | Set this field to 'AU' when providing the ARTG number in B.4.k.4.1. | Default error message. |
| B.4.k.4.3 | drugauthorizationholder | No | Default error message. | ||
| B.4.k.5.1 | drugstructuredosagenumb | Conditional | Where B.4.k.5.2 is provided, B.4.k.5.1 must be provided. | Default error message. | |
| B.4.k.5.2 | drugstructuredosageunit | Conditional | Where B.4.k.5.1 is provided, B.4.k.5.2 must be provided. | Default error message. | |
| B.4.k.5.3 | drugseparatedosagenumb | No | Default error message. | ||
| B.4.k.5.4 | drugintervaldosageunitnumb | Conditional | Where B.4.k.5.4 is provided, B.4.k.5.5 must be provided. | Default error message. | |
| B.4.k.5.5 | drugintervaldosagedefinition | Conditional | Where B.4.k.5.5 is provided, B.4.k.5.4 must be provided. | Default error message. | |
| B.4.k.5.6 | drugcumulativedosagenumb | Conditional | Where B.4.k.5.6 is provided, B.4.k.5.7 must be provided. | Default error message. | |
| B.4.k.5.7 | drugcumulativedosageunit | Conditional | Where B.4.k.5.7 is provided, B.4.k.5.6 must be provided. | Default error message. | |
| B.4.k.6 | drugdosagetext | No | Default error message. | ||
| B.4.k.7 | drugdosageform | No | Default error message. | ||
| B.4.k.8 | drugadministrationroute | No | Default error message. | ||
| B.4.k.9 | drugparadministration | No | Default error message. | ||
| B.4.k.10a | reactiongestationperiod | Conditional | Where B.4.k.10a is provided, B.4.k.10b must be provided. | Default error message. | |
| B.4.k.10b | reactiongestationperiodunit | Conditional | Where B.4.k.10b is provided, B.4.k.10a must be provided. | Default error message. | |
| B.4.k.11a | drugindicationmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.4.k.11b | drugindication | No | If there are multiple indications for use in the case for the product, enter the main indication in B.4.k.11b and include information on the additional indications within the case narrative (B.5.1). Alternatively, the sender can provide more than one iteration (k) for the same drug. | Default error message. | |
| B.4.k.12a | drugstartdateformat | Conditional | Where B.4.k.12b is provided, B.4.k.12a must be provided. | Default error message. | |
| B.4.k.12b | drugstartdate | Conditional | Where B.4.k.12a is provided, B.4.k.12b must be provided. The date specified cannot refer to a future date. | Default error message. | |
| B.4.k.13.1a | drugstartperiod | Conditional | Where B.4.k.13.1a is provided, B.4.k.13.1b must be provided. | B.4.k.13 captures the interval between each drug and only the reaction or event in the first iteration of B.2.i. | Default error message. |
| B.4.k.13.1b | drugstartperiodunit | Conditional | Where B.4.k.13.1b is provided, B.4.k.13.1a must be provided. | Default error message. | |
| B.4.k.13.2a | druglastperiod | Conditional | Where B.4.k.13.2a is provided, B.4.k.13.2b must be provided. | Default error message. | |
| B.4.k.13.2b | druglastperiodunit | Conditional | Where B.4.k.13.2b is provided, B.4.k.13.2a must be provided. | Default error message. | |
| B.4.k.14a | drugenddateformat | Conditional | Where B.4.k.14b provided, B.4.k.14a must be provided. | Default error message. | |
| B.4.k.14b | drugenddate | Conditional | Where B.4.k.14a provided, B.4.k.14b must be provided. | Leave blank for ongoing drug administration following onset of reaction or event | Default error message. |
| The date specified cannot refer to a future date. | |||||
| B.4.k.15a | drugtreatmentduration | Conditional | Where B.4.k.15a is provided, B.4.k.15b must be provided. | Default error message. | |
| B.4.k.15b | drugtreatmentdurationunit | Conditional | Where B.4.k.15b is provided, B.4.k.15a must be provided. | Default error message. | |
| B.4.k.16 | actiondrug | No | 'Not applicable' should be used in circumstances such as if the patient died or the treatment had been completed prior to the reaction or event. | Default error message. | |
| B.4.k.17.1 | drugrecurreadministration | No | 'Unknown' indicates that a rechallenge was done, but it is unknown if the event recurred. This data element should not be completed if it is unknown whether a rechallenge was done. | Default error message. | |
| B.4.k.17.2a | drugrecuractionmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a. | Default error message. | |
| B.4.k.17.2b | drugrecuraction | No | Default error message. | ||
| B.4.k.18.1a | drugreactionassesmeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a. | Generally ordered from the most important or the most serious to the least important. | Default error message. |
| B.4.k.18.1b | drugreactionasses | No | Must be the same as a provided reaction/event in MedDRA terminology (LLT) specified in B.2.i.1.b or the same as the MedDRA preferred term (PT) specified in B.2.i.2.b. | Where drugreactionasses is provided, the source, result and method of assessment should be completed. | Default error message. |
| B.4.k.18.2 | drugassessmentsource | No | Default error message. | ||
| B.4.k.18.3 | drugassessmentmethod | No | Default error message. | ||
| B.4.k.18.4 | drugresult | No | Default error message. | ||
| B.4.k.19 | drugadditional | No | B.4.k.19 may be used to specify additional information pertinent to the case that is not covered by above sections (for example, beyond expiration date, batch and lot tested and found to be within specifications) or additional information on the indication for the drug. | Default error message. |
B.5 Narrative case summary and further information
| E2B R2 element | DTD descriptor | Mandatory field | TGA specific validation rules | Notes | Acknowledgement response error messages |
|---|---|---|---|---|---|
| B.5.1 | narrativeincludeclinical | No | Focused, factual, and clear description of the case should be given, including the words or short phrases used by the reporter. | Default error message. | |
| B.5.2 | reportercomment | No | Reporter's comments on the diagnosis, causality assessment, or other issues considered relevant. | Default error message. | |
| B.5.3a | senderdiagnosismeddraversion | Conditional | Must be the same as the MedDRA version at B.2.i.1.a | Default error message. | |
| B.5.3b | senderdiagnosis | No | Opportunity to combine signs and symptoms that were reported into a succinct diagnosis. | Default error message. | |
| B.5.4 | sendercomment | No | Information concerning the sender's assessment of the case and can be used to describe disagreement with, and/or alternatives to the diagnoses given by the initial reporter. | Default error message. |