E2B(R3) dictionary
Mapping your questions to the E2B(R3) format is essential to the transmission of adverse event data to Safety. This ensures that the data integrates to the appropriate field in Safety.
For data to be successfully integrated with Safety, ensure that the data type and setup details for each data item matches the information in the table below.
You can map the answers site users add to questions by using E2B(R3) codelists. For more information, see About E2B(R3) codelists.
WARNING:
Incorrectly mapped data cannot be integrated with Safety.To learn more about the Oracle Clinical One Platform integration with Safety, see Clinical One to Safety.
Note:
In the table below, whenever the Required in Safety column contains a value of "Yes", the Required for Case Creation toggle is available for that mapping. For more information, see Design questions to be integrated to Safety. Furthermore, for your case to be integrated to Safety, the following mappings must have the Required for Case Creation toggle switched on:- E.i.1.1a (Reaction / Event as Reported by the Primary Source in Native Language) or E.i.1.2 (Reaction / Event as Reported by the Primary Source for Translation)
- G.k.1 (Characterization of Drug Role) and G.k.2.2 (Medicinal Product Name as Reported by the Primary Source)'
- If using, E.i.2.1a (MedDRA Version for Reaction / Event) and E.i.2.1b (Reaction / Event (MedDRA code)).
Table 6-3 E2B(R3) elements
| Category | Data Element Number | Data Element Name | Required in Safety? | Max length | Field type | Notes |
|---|---|---|---|---|---|---|
| D. Patient Characteristics | D.1 | Patient (name or initials) | Yes | 60 | Text | N/A |
| D. Patient Characteristics | D.1.1.1 | Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number) | No | 20 | Text | N/A |
| D. Patient Characteristics | D.1.1.2 | Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number) | No | 20 | Text | N/A |
| D. Patient Characteristics | D.1.1.3 | Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number) | No | 20 | Text | N/A |
| D. Patient Characteristics | D.1.1.4 | Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) | No | 20 | Text | N/A |
| D. Patient Characteristics | D.2.1 | Date of Birth | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D. Patient Characteristics | D.2.2a | Age at Time of Onset of Reaction / Event (number) | No | 5 | Number | N/A |
| D. Patient Characteristics | D.2.2b | Age at Time of Onset of Reaction / Event (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D. Patient Characteristics | D.2.2.1a | Gestation Period When Reaction / Event Was Observed in the Foetus (number) | No | 3 | Number | N/A |
| D. Patient Characteristics | D.2.2.1b | Gestation Period When Reaction/Event Was Observed in the Foetus (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D. Patient Characteristics | D.2.3 | Patient Age Group (as per reporter) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D. Patient Characteristics | D.3 | Body Weight (kg) | No | 6 | Number | N/A |
| D. Patient Characteristics | D.4 | Height (cm) | No | 3 | Number | Decimals are not supported. |
| D. Patient Characteristics | D.5 | Sex | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D. Patient Characteristics | D.6 | Last Menstrual Period Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.1a | MedDRA Version for Medical History | No | 4 | Text | N/A |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.1b | Medical History (disease / surgical procedure / etc.) (MedDRA code) | No | 8 | Number | N/A |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.2 | Start Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.3 | Continuing | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.4 | End Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.5 | Comments | No | 2000 | Text | N/A |
| D.7.1.r Structured Information on Relevant Medical History | D.7.1.r.6 | Family History | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D. Patient Characteristics | D.7.2 | Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) | No | 10000 | Text | N/A |
| D. Patient Characteristics | D.7.3 | Concomitant Therapies | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.8.r Relevant Past Drug History | D.8.r.1 | Name of Drug as Reported | No | 250 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.2a | MPID Version Date/Number | No | 10 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.2b | Medicinal Product Identifier (MPID) | No | 1000 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.3a | PhPID Version Date/Number | No | 10 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.3b | Identifier (PhPID) | No | 250 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.4 | Start Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.8.r Relevant Past Drug History | D.8.r.5 | End Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.8.r Relevant Past Drug History | D.8.r.6a | MedDRA Version for Indication | No | 4 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.6b | Indication (MedDRA code) | No | 8 | Number | N/A |
| D.8.r Relevant Past Drug History | D.8.r.7a | MedDRA Version for Reaction | No | 4 | Text | N/A |
| D.8.r Relevant Past Drug History | D.8.r.7b | Reaction (MedDRA code) | No | 8 | Number | N/A |
| Patient Characteristics | D.9.1 | Date of Death | No | N/A | Date/Time | N/A |
| D.9.2.r Reported Cause(s) of Death | D.9.2.r.1a | No | 4 | Text | N/A | |
| D.9.2.r Reported Cause(s) of Death | D.9.2.r.1b | MedDRA Version for Reported Cause(s) of Death | No | 8 | Number | N/A |
| D.9.2.r Reported Cause(s) of Death | D.9.2.r.2 | Reported Cause(s) of Death (free text) | No | 250 | Text | N/A |
| D. Patient Characteristics | D.9.3 | Was Autopsy Done? | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.9.4.r Autopsy-determined Cause(s) of Death | D.9.4.r.1a | MedDRA Version for Autopsy-determined Cause(s) of Death | No | 4 | Text | N/A |
| D.9.4.r Autopsy-determined Cause(s) of Death | D.9.4.r.1b | Autopsy-determined Cause(s) of Death (MedDRA code) | No | 8 | Number | N/A |
| D.9.4.r Autopsy-determined Cause(s) of Death | D.9.4.r.2 | Autopsy-determined Cause(s) of Death (free text) | No | 250 | Text | N/A |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.1 | Parent Identification | No | 60 | Text | N/A |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.2.1 | Date of Birth of Parent | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.2.2a | Age of Parent (number) | No | 3 | Number | N/A |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.2.2b | Age of Parent (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.3 | Last Menstrual Period Date of Parent | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.4 | Body Weight (kg) of Parent | No | 6 | Number | N/A |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.5 | Height (cm) of Parent | No | 3 | Number | This field does not allow decimals |
| D.10 For a Parent-Child / Foetus Report, Information Concerning the Parent | D.10.6 | Sex of Parent | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.1a | MedDRA Version for Medical History | No | 4 | Text | N/A |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.1b | Medical History (disease / surgical procedure / etc.) (MedDRA code) | No | 8 | Number | N/A |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.2 | Start Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.3 | Continuing | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.4 | End Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10.7.1.r Structured Information of Parent | D.10.7.1.r.5 | Comments | No | 2000 | Text | N/A |
| D.10.7 Relevant Medical History and Concurrent Conditions of Parent | D.10.7.2 | Text for Relevant Medical History and Concurrent Conditions of Parent | No | 10000 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.1 | Name of Drug as Reported | No | 250 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.2a | MPID Version Date/Number | No | 10 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.2b | Medicinal Product Identifier (MPID) | No | 1000 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.3a | PhPID Version Date/Number | No | 10 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.3b | Pharmaceutical Product Identifier (PhPID) | No | 250 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.4 | Start Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.5 | End Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.6a | MedDRA Version for Indication | No | 4 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.6b | Indication (MedDRA code) | No | 8 | Number | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.7a | MedDRA Version for Reaction | No | 4 | Text | N/A |
| D.10.8.r Relevant Past Drug History of Parent | D.10.8.r.7b | Reactions (MedDRA code) | No | 8 | Number | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.1.1a | Reaction / Event as Reported by the Primary Source in Native Language | Yes | 250 | Text | For your case to be transmitted to Safety successfully, either this data element or E.i.1.2 must have the Required for Case Creation toggle switched on. |
| E.i Reaction/Event as Reported by the Primary Source | E.i.1.1b | Reaction / Event as Reported by the Primary Source Language | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.1.2 | Reaction / Event as Reported by the Primary Source for Translation | Yes | 250 | Text | For your case to be transmitted to Safety successfully, either this data element or E.i.1.1a must have the Required for Case Creation toggle switched on. |
| E.i Reaction/Event as Reported by the Primary Source | E.i.2.1a | MedDRA Version for Reaction / Event | Yes | 4 | Text | For this data element to be integrated with Safety, the Required for Case Creation toggle must be enabled for E.i.2.1b. |
| E.i Reaction/Event as Reported by the Primary Source | E.i.2.1b | Reaction / Event (MedDRA code) | Yes | 8 | Number | For E.i.2.1a to be integrated with Safety, the Required for Case Creation toggle must be enabled for this data element. |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.1 | Term Highlighted by the Reporter | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2a | Results in Death | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2b | Life Threatening | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2c | Caused / Prolonged Hospitalization | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2d | Disabling / Incapacitating | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2e | Congenital Anomaly / Birth Defect | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.3.2f | Other Medically Important Condition | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.4 | Date of Start of Reaction/Event | No | N/A | Date/Time | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.5 | Date of End of Reaction/Event | No | N/A | Date/Time | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.6a | Duration of Reaction/Event (number) | No | 5 | Number | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.6b | Duration of Reaction/Event (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.7 | Outcome of Reaction/Event at the Time of Last Observation | Yes | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.8 | Medical Confirmation by Healthcare Professional | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| E.i Reaction/Event as Reported by the Primary Source | E.i.9 | Identification of the Country Where the Reaction/Event Occurred | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.1 | Test Date | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.2.1 | Test Name (free text) | No | 250 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.2.2a | MedDRA Version for Test Name | No | 4 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.2.2b | Test Name (MedDRA code) | No | 8 | Number | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.3.1 | Test Result (code) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.3.2 | Test Result (value/qualifier) | No | 50 | Number | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.3.3 | Test Result (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.3.4 | Result Unstructured Data (free text) | No | 2000 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.4 | Normal Low Value | No | 50 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.5 | Normal High Value | No | 50 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.6 | Comments (free text) | No | 2000 | Text | N/A |
| F.r Results of Tests and Procedures Relevant to the Investigation of the Patient | F.r.7 | More Information Available | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.1 | Characterization of Drug Role | Yes | N/A | Drop-down/Checkbox/Radio button | For your case to be transmitted to Safety successfully, this data element and G.k.2.2 must have the Required for Case Creation toggle enabled. |
| G.k Drug(s) Identification | G.k.2.1.1a | MPID Version Date/Number | No | 10 | Text | N/A |
| G.k Drug(s) Identification | G.k.2.1.1b | Medicinal Product Identifier (MPID) | No | 1000 | Text | N/A |
| G.k Drug(s) Identification | G.k.2.1.2a | PhPID Version Date/Number | No | 10 | Text | N/A |
| G.k Drug(s) Identification | G.k.2.1.2b | Pharmaceutical Product Identifier (PhPID) | No | 250 | Text | N/A |
| G.k Drug(s) Identification | G.k.2.2 | Medicinal Product Name as Reported by the Primary Source | Yes | 250 | Text | For your case to be transmitted to Safety successfully, this data element and G.k.1 must have the Required for Case Creation toggle enabled. |
| G.k.2.3.r Substance / Specified Substance Identifier and Strength | G.k.2.3.r.1 | Substance/Specified Substance Name | No | 250 | Text | N/A |
| G.k.2.3.r Substance / Specified Substance Identifier and Strength | G.k.2.3.r.2a | Substance/Specified Substance TermID Version Date/Number | No | 10 | Text | N/A |
| G.k.2.3.r Substance / Specified Substance Identifier and Strength | G.k.2.3.r.2b | Substance/Specified Substance TermID | No | 100 | Text | N/A |
| G.k.2.3.r Substance / Specified Substance Identifier and Strength | G.k.2.3.r.3a | Strength (number) | No | 10 | Number | N/A |
| G.k.2.3.r Substance / Specified Substance Identifier and Strength | G.k.2.3.r.3b | Strength (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.2.4 | Identification of the Country Where the Drug Was Obtained | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.2.5 | Investigational Product Blinded | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.3.1 | Authorization/Application Number | No | 35 | Text | N/A |
| G.k Drug(s) Identification | G.k.3.2 | Country of Authorization/Application | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.3.3 | Name of Holder/Applicant | No | 60 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.1a | Dose (number) | No | 8 | Number | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.1b | Dose (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.2 | Number of Units in the Interval | No | 4 | Number | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.3 | Definition of the Time Interval Unit | No | 50 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.4 | Date and Time of Start of Drug | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.5 | Date and Time of Last Administration | No | N/A | Date/Time | The minimum input this fields accepts is the year. |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.6a | Duration of Drug Administration (number) | No | 5 | Number | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.6b | Duration of Drug Administration (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.7 | Batch/Lot Number | No | 35 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.8 | Dosage Text | No | 2000 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.9.1 | Pharmaceutical Dose Form (free text) | No | 60 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.9.2a | Pharmaceutical Dose Form TermID Version Date/Number | No | 10 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.9.2b | Pharmaceutical Dose Form TermID | No | 100 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.10.1 | Route of Administration (free text) | No | 60 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.10.2a | Route of Administration TermID Version Date/Number | No | 10 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.10.2b | Route of Administration TermID | No | 100 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.11.1 | Parent Route of Administration (free text) | No | 60 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.11.2a | Parent Route of Administration TermID Version Date / Number | No | 10 | Text | N/A |
| G.k.4.r Dosage and Relevant Information | G.k.4.r.11.2b | Parent Route of Administration TermID | No | 100 | Text | N/A |
| G.k Drug(s) Identification | G.k.5a | Cumulative Dose to First Reaction (number) | No | 10 | Number | N/A |
| G.k Drug(s) Identification | G.k.5b | Cumulative Dose to First Reaction (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.6a | Gestation Period at Time of Exposure (number) | No | 3 | Number | N/A |
| G.k Drug(s) Identification | G.k.6b | Gestation Period at Time of Exposure (unit) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k.7.r Indication for Use in Case | G.k.7.r.1 | Indication as Reported by the Primary Source | No | 250 | Text | N/A |
| G.k.7.r Indication for Use in Case | G.k.7.r.2a | MedDRA Version for Indication | No | 4 | Text | N/A |
| G.k.7.r Indication for Use in Case | G.k.7.r.2b | Indication (MedDRA code) | No | 8 | Number | N/A |
| G.k Drug Identification | G.k.8 | Action(s) Taken with Drug | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.10.r | Additional Information on Drug (coded) | No | N/A | Drop-down/Checkbox/Radio button | N/A |
| G.k Drug(s) Identification | G.k.11 | Additional Information on Drug (free text) | No | 2000 | Text | N/A |
| H Narrative Case Summary and Further Information | H.1 | Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information | Yes | 10000 | Text | N/A |
| H Narrative Case Summary and Further Information | H.2 | Reporter's Comments | No | 20000 | Text | N/A |
| H.3.r Sender's Diagnosis | H.3.r.1a | MedDRA Version for Sender's Diagnosis/Syndrome and/or Reclassification of Reaction/Event | No | 4 | Text | N/A |
| H.3.r Sender's Diagnosis | H.3.r.1b | Sender's Diagnosis/Syndrome and/or Reclassification of Reaction/Event (MedDRA code) | No | 8 | Number | N/A |
| H Narrative Case Summary and Further Information | H.4 | Sender's Comments | No | 20000 | Text | N/A |
| H.5.r Case Summary and Reporter’s Comments in Native Language | H.5.r.1a | Case Summary and Reporter’s Comments Text | No | 10000 | Text | N/A |
| H.5.r Case Summary and Reporter’s Comments in Native Language | H.5.r.1b | Case Summary and Reporter’s Comments Language | No | N/A | Drop-down/Checkbox/Radio button | N/A |
Parent topic: Design and configure questions for safety integrations