ICSR forms

Case Number

An autonumbering field that you cannot amend manually. By default, the case number is generated according to the formula: [Four-digit year]-[Case No.Abbreviation]-[Six-digit serial number].

The Case No.Abbreviation element of the preceding formula you can configure via System Parameters according to your business requirements.

Case Version

An autonumbering field that you cannot amend manually. Your initial case is assigned number 001, and the follow-up data will have version numbers 002, 003, and so on.

Case Status

An autofilled field that the system completes with the current workflow status of your case, for instance, Draft or Data Entry.

Case Language*

Select the language in which the AE/SAE case you are reporting is recorded.

Case Country*

Select the country in which the first AE occurred at the time of the initial report.

Initial or Follow-up?*

Represents if the report is initial (the case is reported for the first time) or follow-up (the data in the report is an additional/updated version of the previously reported case).

Significant

Select the respective option, as follows:

This field is only available for the reports of the Follow-up type. The field is missing in the forms of the Initial reports.

Final Report

Select the respective option, as follows:

Case Source

The value is autopopulated by the system and represents the manner in which the case is created.

MedDRA Version*

Select the MedDRA version according to which the reported data is coded (standardized).

By default for new ICSRs created from scratch, the latest MedDRA version is autopopulated, however, it can be changed to meet your business needs.

For EMA and NMPA submission-oriented cases, due to regulatory requirements, you can only select the latest or the previous to the latest MedDRA version. Otherwise, the ICSR validation fails.

WHODrug Version

Select the WHODrug version according to which the reported product data is coded (standardized).

By default for new ICSRs created from scratch, the latest WHODrug version is autopopulated, however, it can be changed to meet your business needs.

Product Type*

Select the type of product reported for the AE/SAE case.

Classification

Select one or more categories to which your case belongs to outline the nature of the report:

NMPA ICSR Type

Select the ICSR type according to the NMPA requirements.

NMPA Report Source

Select the source of your ICSR according to the NMPA requirements.

Safety Report ID

An automatically calculated identification number that comprises the following three elements according to the ICH E2B (R3) standard: [Reporter's Country]-[Company Name Abbreviation]-[Case No.].

The Company Name Abbreviation element of the preceding formula you can configure via System Parameters according to your business requirements.

Type of Report*

Select the report types to which your ICSR relates.

Initial Received Date*

Select the date to specify when the initial AE/SAE case data has been first received.

Latest Received Date*

Select the date to specify when the latest version of the AE/SAE case data has been received.

Safety Received Date*

Select the dates to specify when the safety department first received the AE/SAE case.

Additional Documents Available?

Represents an autocalculated value of whether the documents are uploaded in the report via the Attachments form as follows:

This field is only available if Case Source is selected as E2B R3 Import Manually or E2B R3 Gateway Received.

Expedited Report Required?

Represents an autocalculated value of whether the report is to be considered expedited—such that requires immediate attention due to its seriousness, severity, or potential impact on public health.

This value is based on the Expedited Report value set upon submission destination configuration.

Worldwide Unique Case ID

An automatically calculated identification number that is typically the same as the Safety Report ID value.

First Sender of This Case?*

Select the respective option to represent the person/institution that was the first reporter of the occurred AE/SAE case.

Has Other Case Identifiers in Previous Transmissions?

Select Yes if ICSR either has been exchanged by the two parties in the past using a different identifier or has been exchanged simultaneously with a different identifier. For the ICSR created from scratch or sent from EDC, the No Information option is preselected and cannot be manually changed.

Report Nullification / Amendment?

Select the respective option to indicate the following:

The date originally reported in Latest Received Date should not be changed in an amended or nullified report if no new information on the case has been received from a primary source.

Reason for Nullification / Amendment

Enter the reason why a previously transmitted ICSR is either considered completely nullified or has been amended, depending on the value selected for Report Nullification / Amendment.

Case Serious

The value in this field is set to Yes automatically if at least one event has been recorded as serious in the Events form. If none of the events have been recorded as serious, then the value in this field is set to No automatically.

Notes for Case Serious Change

Represents a free-text field to provide justification for changes in case seriousness.

Results in Death

Represents if the case resulted in the patient's death (Yes) or not (No).

The value is populated from the Results in Death field of the Events form.

Life Threatening

Represents if the case occurrence threatens the patient's life (Yes) or not (No).

The value is populated from the Life Threatening field of the Events form.

Caused / Prolonged Hospitalisation

Represents if the case occurrence led to/prolonged the patient's hospitalization (Yes) or not (No).

The value is populated from the Caused / Prolonged Hospitalisation field of the Events form.

Disabling / Incapacitating

Represents if the case occurrence led to the patient's disability or incapacity (Yes) or not (No).

The value is populated from the Disabling / Incapacitating field of the Events form.

Congenital Anomaly / Birth Defect

Represents if the case occurrence led to the patient's congenital anomaly or birth defect (Yes) or not (No).

The value is populated from the Congenital Anomaly / Birth Defect field of the Events form.

Important Medical Event

Represents if the case occurrence is an important (significant) medical event (Yes) or not (No).

The value is populated from the Important Medical Event field of the Events form.

Case Causality

Select either Related or Not Related causality for the manually created ICSR.

Notes for Case Causality Change

Represents a free-text field to provide justification for changes in case causality.

Case Expectedness

The value in this field is set to Unexpected automatically if at least one recorded event has been assessed as unexpected in the Assessment form.

Notes for Case Expectedness Change

Represents a free-text field to provide justification for changes in case expectedness.

Case Outcome

A read-only field that represents the most current state of the case.

Case Due Date

Enter the report processing deadline according to your business process specification. Only manual input is supported for the time being, and automatic calculation will be available in the future.

Remaining Time

An auto-calculated value that represents the number of days remaining from the current date (when you are completing the form) to the deadline set via the Case Due Date field.

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select to implement the changes of the General form.

Study Name*

Represents the study for which the case is reported.

To populate the value to this field, select the study using the Select Study option.

Select Study

Click Select Study to open the Select Study and Arm dialog and select the study and arm for which the case is reported.

The search results are based on the study access permission granted via ADMIN.

Once the selection is made, click .

Figure 3. Selecting study and arm

Select Filter to apply filtering and search for a study by its name, description, or number.

Note that based on the selected study and arm the system automatically creates product records for your ICSR. If а blind arm іс selected, only one product record with this arm name is created even if there are more blind study products in the arm.

Study Phase

Represents the study phase during which the reported case has occurred. An automatically filled value that depends on the selection you have made with the Select Study option.

Study Arm Name

Represents the name of the study arm for which the reported case has occurred. An automatically filled value that depends on the selection you have made with the Select Study option.

However, for data migration, if the field is not autopopulated, select the arm manually by clicking Select Study Arm (Migration Only) and selecting the study and arm.

The search results are based on the study access permission granted via ADMIN.

Figure 4. Selecting study arm

Blind Type

Represents the blinding type of the selected study—Open Label, Blinded, and so on.

Sponsor Study Number

Represents the study identification number assigned by the sponsor. An automatically filled value that depends on the selection you have made with the Select Study option.

Observe Study Type

Represents the type of the study according to the E2B R3 standard, such as clinical trials, individual patient use, or other studies (for instance, pharmacoepidemiology or intensive monitoring).

IND Number where AE Occurred

Enter the Investigational New Drug (IND) number for which the case is reported.

Study Description

Represents the description of the study. The value is automatically pulled from the study description provided upon configuration and depends on the selected study.

Translation

Select next to the form field and in the dialog that opens, review the translation text pulled from the study description translation provided upon configuration. You can also manually enter or amend the existing translation text. Once ready, save the changes.

You can learn more about the translation capabilities in the Translate ICSR form field section.

Blinding Status

Select the blinding status of your study. This field is populated upon the study selection, although it can be changed manually if your user has the respective system permission.

Note that when the blinding status is changed to Broken After Study or Broken by Investigator, it cannot be changed back to Blinded.

Unblinding Date

Select the date when the study was unblinded.

This field is only enabled if the case is in one of the unblinding statuses—Broken After Study or Broken by Investigator—and if your user has the system permission to unblind.

Reason for Unblinding

Enter the reason for unblinding the study.

This field is only enabled if the case is in one of the unblinding statuses—Broken After Study or Broken by Investigator—and if your user has the system permission to unblind.

SAVE

Select to save the implemented changes of the Study form.

Reporter's Title

Represents the reporter's official title.

Reporter's Last Name

Represents the reporter's last name.

Reporter's Middle Name

Represents the reporter's middle name.

Reporter's First Name*

Represents the reporter's first name

Reporter's Organisation

Represents the name of the organization to which the reporter belongs.

Reporter's Department

Represents the department name within the reporter's organization to which they belong.

Reporter's Country

Represents the country of the reporter's residence.

Reporter's State or Province

Represents the state or province of the reporter's residence.

Reporter's County

Represents the county of the reporter's residence.

Reporter's City

Represents the city of the reporter's residence.

Reporter's Street

Represents the street of the reporter's residence.

Reporter's Street Address - LINE 2

Represents the alternate street of the reporter's residence.

Reporter's Postcode

Represents the reporter's postcode.

Reporter's Telephone

Represents the reporter's contact telephone number.

Reporter's Email

Represents the reporter's contact email address.

Reporter's Fax Number

Represents the reporter's contact fax number.

Reporter's Qualification

Represents the reporter's qualification such as a Lawyer, Physician, or else.

Primary Source for Regulatory Purposes?

The Yes option is selected if the reporter is the primary source of information underlying the ICSR.

Health Care Professional?

Represents the autoselected option that depends on the value of the Reporter's Qualification field. The system logic is as follows:

You can change the selection manually if you want to state whether the reporter is a specialist in the healthcare industry.

Initial Reporter Also Sent Report to FDA?

The selected option represents if the reporter has also submitted the case occurrence to the FDA along with the ICSR creation.

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select to save the implemented changes of the Reporter form.

Select this icon to add a new reporter to the ICSR. Bear in mind, that you can add new reporters only after saving the previous one.

Patient Name or Initials

Represents the patient's name or initials.

GP Medical Record Number

Enter the health record ID of the patient (subject), which, depending on the business scenario, can be the health professional record number, hospital record number, or subject identification number in a study.

Specialist Record Number

Enter the record number of the healthcare professional caring for the patient.

Hospital Record Number

Enter the record number of the facility where the patient is located.

Subject ID

Enter the ID number assigned to a subject during the course of the study.

Date of Birth

Select the date of birth of the patient.

Onset Age

Represents the age of the patient at the time of event onset. This value is autocalculated by the system based on the specified date of the patient's birth and considering the Onset Date/Time value set in the Events form.

To amend the value, select the Manual checkbox.

Onset Age Unit

Represents the unit to measure the age of the patient. For the autocalculated Onset Age value, the unit is also autopopulated by the system.

To amend the value, select the Manual checkbox.

Manual

Select this checkbox next to both the Onset Age or Onset Age Unit field to change their value manually disabling the autocalculation functionality.

Figure 3. Manually updating onset age details

Gestation Period when Event was observed in Fetus (Number)

Represents the gestation period when an adverse reaction or event has been observed in the fetus. The focus here is not on the fetus but on the pregnant patient who carries this fetus and experienced an adverse event or reaction.

Gestation Period when Event was observed in Fetus (Unit)

Represents the unit to measure the value of the gestation period when the adverse reaction or event has been observed in the fetus.

Patient Age Group as per Reporter

Represents the age group to which the patient belongs.

Weight

Represents the weight of the patient.

Weight Unit

Represents the unit to measure the weight of the patient.

Height

Represents the height of the patient.

Height Unit

Represents the unit to measure the height of the patient.

Sex

Represents the sex of the patient.

Last Menstrual Period Date

Represents the date when the last menstrual cycle has ended. This field is enabled only if the sex of the patient is female.

Pregnant?

Represents the pregnancy status of the patient. This field is enabled only if the sex of the patient is female.

Child Only Case?

Select Yes if the case is related to the child only.

Ethnicity

Represents the ethnicity of the patient.

Race

Represents the race of the patient. You can select multiple values in this field.

Other Race

If the patient's race code is Other, enter the race of the patient manually in this field.

Text for Relevant Medical History and Concurrent Conditions Not Including Reaction / Event

Represents information about medical history records that could not be coded in the Patient Medical History form. The None value should be used here when there is no relevant medical history and no concurrent conditions reported. If relevant patient medical history is not documented at the time of the report, this field is set to UNK.

Concomitant Therapies?

Select Yes if at the time of the reaction, there have been concomitant therapies such as radiotherapy, drug class, dietary supplements, or other products described in the Product form. If no products have been added, relevant information needs to be entered in the Narrative form.

Date of Death

Represents the date of the patient's death. You need to fill in the Cause of Death form afterward.

Death Certificate Obtained?

Select Yes, No, or Pending depending on whether the death certificate has been received or is pending obtainment.

Was Autopsy Done?

Represents the status of the autopsy for the deceased patient. This field becomes required if the date of death is mentioned. If Yes is selected, the Autopsy Results form becomes available.

D.CN.1 Ethnic Groups (China)

Represents the ethnic group to which the patient belongs under the condition that this patient is from China.

D.CN.2 Patient Race Code (China)

Represents the race to which the patient belongs under the condition that this patient is from China.

D.CN.3 Hospital Name (China)

Represents the name of the medical facility where the patient is registered under the condition that this patient is from China.

D.CN.4 Patient Country

Represents the country of the patient.

Patient Telephone

Represents the phone number of the patient.

D.CN.6 Pregnancy Description (China)

Represents the description of the patient's pregnancy under the condition that this patient is from China.

Patient Name Prefix

Represents the abbreviation of the patient's name.

Patient First Name

Represents the first name of the patient.

Patient Middle Name

Represents the middle name of the patient.

Patient Last Name

Represents the last name of the patient.

Patient Address Line 1

Represents the address of the patient.

Patient Address Line 2

Represents the address of the patient in case it does not fit in the first line.

Patient Address City

Represents the city where the patient currently lives.

Patient Address State or Foreign Province Name

Represents the state or province where the patient currently lives.

Patient Address Country

Represents the country where the patient currently lives.

Patient Address Postal Code

Represents the postal code of the patient's current living location.

Patient Email

Represents the email address of the patient.

Age Number at Time of Vaccination

Represents the age of the patient when they have been vaccinated.

Age Unit at Time of Vaccination

Represents the unit to measure the age of the patient when they have been vaccinated.

SAVE

Select to save the implemented changes of the Patient form.

Verbatim Term*

Select to choose the MedDRA LLT term for the medical history record of the patient. All the details pertaining to the selected term are populated in the corresponding fields of the form and they are disabled by default.

Start Date

Represents the date when the disease has started.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the start date not to be later than the end date.

Ongoing?

Represents the current status of the disease.

End Date

Represents the date when the disease has ended.

This field becomes available if the disease is not ongoing anymore (the Ongoing field value is set to No).

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the end date not to be earlier than the start date.

Comments

Represents additional comments that may help to give further details to the medical history that cannot be captured with just the term, code, start, and end dates.

Family History

Select Yes if the reported disease has occurred in family members of the patient.

Select this icon to add a new medical record related to the patient. Bear in mind, you can add new records only after saving the form with the previously added medical record.

Translation

Select next to the form field to translate its value into available languages.

Reported Cause(s) of Death

Select to choose the MedDRA LLT term for the reported cause of death of the patient. All the details pertaining to the selected LLT term are populated in the corresponding fields of the form and they are disabled by default. The reported cause of death needs to be entered manually.

Select this icon to add a new reported cause of the patient's death. Bear in mind, you can add new causes only after saving the form with the previously added cause of death.

Autopsy-determined Cause(s) of Death

Select to choose the MedDRA LLT term for the autopsy-determined cause of death of the patient after it has been mentioned that the autopsy has been done. All the details pertaining to the selected LLT term are populated in the corresponding fields of the form and they are disabled by default. The autopsy-determined cause needs to be entered manually.

Select this icon to add a new autopsy-determined cause of the patient's death. Bear in mind, you can add new causes only after saving the form with the previously added autopsy-determined cause of death.

Product Name*

Enter the product name previously given to the patient. Or select WHODrug to apply WHODrug coding to the existing product.

Start Date

Specify the date when the patient has started taking the indicated drug.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024". However, the system validates the start date not to be later than the end date.

End Date

Specify the date when the patient has finished taking the indicated drug.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024". However, the system validates the end date not to be earlier than the start date.

Medicinal Product Identifier (MPID)

Enter the definition of the drug as per ISO 11615 Medicinal Product Identification (MPID). This field is inactive if you enter any value in the Pharmaceutical Product Identifier (PhPID) or PhPID Version Date / Number field.

MPID Version

Enter the version of the drug as per ISO 11615 Medicinal Product Identification (MPID). This field is inactive if you enter any value in the Pharmaceutical Product Identifier (PhPID) or PhPID Version Date / Number field.

Pharmaceutical Product Identifier (PhPID)

Enter a unique identifier calculated by an algorithm based on substance identification (ISO 11238), dosage form (ISO 11239), and strengths with units of measurement (ISO 11240). This field is inactive if you enter any value in the Medicinal Product Identifier (MPID) or MPID Version Date / Number field.

PhPID Version

Enter the version of the pharmaceutical product identifier. This field is inactive if you enter any value in the Medicinal Product Identifier (MPID) or MPID Version Date / Number field.

WHO Drug Version

Represents the version of the World Health Organization (WHO) Drug Dictionary used for coding drug information. The field is read-only and populated via product coding.

WHO Drug Coding Type

Represents the type of coding used for adding the product. The field is read-only and populated via product coding.

WHO Drug Code

Represents a unique identifier for a drug within the WHO Drug Dictionary. The field is read-only and populated via product coding.

WHO MPID

Represents the WHO medical product identifier, which is a unique number assigned to a drug for identification purposes. The field is read-only and populated via product coding.

Trade Name

Enter the trade or brand name of the medicine.

Generic Name

Enter the chemical name of the drug based on the compound's chemical structure.

Trademark Name

Enter the company name that owns the product.

Strength Name

Enter the name of the active ingredient in the drug.

Form Name

Enter one of the common drug dosages, for example, capsules, pills, and so on.

Container Name

Enter the name of the packaging used to store the drug, for example, the bottle.

Device Name

Enter the name of the medical device.

Intended Use Name

Enter the population or condition for which the product is intended to be used, for example, intended for children aged 0-12 months, intended use for heartburn relief, and so on.

Indication

Select MedDRA Search to apply MedDRA term coding for the state of the patient when the drug has been given to them. The details about the selected term are populated in corresponding fields of the form and they are inactive by default.

Reaction

Select MedDRA Search to apply MedDRA term coding for the patient's reaction to the given drug if any. The details about the selected term are populated in corresponding fields of the form and they are inactive by default.

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select to save and add the drug to the patient's drug history.

Select this icon to add another drug to the patient's drug history.

Note that you can add new drugs only after saving the previously added drug record.

Substance Name*

Enter the name of the substance or ingredient in the given drug.

Substance TermID

Enter the ID of the substance in the given drug as per ISO IDMP standards.

Substance TermID Version

Enter the version of the substance in the given drug as per ISO IDMP standards.

Strength

Enter the amount of drug in the given dosage form, for example, 200 mg/tablet.

Strength Unit

Select the unit to measure the strength of the given drug, for example, mg.

Select this icon to add another drug substance to the patient's drug history.

Note that you can add new drug substances only after saving the previously added one.

Test Date*

Represents the date when the lab test has occurred.

Test Name*

Select to choose the MedDRA LLT term for the lab test that has been done. All the details pertaining to the selected term are populated in the corresponding fields of the form and they are disabled by default.

Test Result Code

Represents the outcome of the lab test. If the test result code is selected, the Test Result (Qualifier) and Test Result (Free Text) fields become disabled.

Test Result (Qualifier)

Represents the indicators for test results that qualify for a set of reference ranges, for example, equal to, equal to or greater than, and so on. If the test result qualifier is specified, the Test Result Code and Test Result (Free Text) fields become disabled.

Test Result (Value)

Represents the test result value. This field is available only if the test result qualifier has been specified.

Test Result (Unit)

Represents the unit to measure the test result value. This field is available only if the test result qualifier has been specified.

Test Result (Free Text)

Represents the test result value described in a free text. If the test result is entered manually, the Test Result (Code) and Test Result (Qualifier) fields become disabled.

Normal Low Value

Represents the lowest normal value in the performed lab test.

Normal High Value

Represents the highest normal value in the performed lab test.

Comments

Represents any comment related to the performed lab test.

More Information Available?

Select Yes if there is more information held by the company about the test and test results. If Yes is selected, relevant lab documents must be uploaded and described in the Attachments form.

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select to save and add the lab test to the ICSR.

Select this icon to add another lab test to the ICSR. Note that you can add new lab tests only after saving the previously added one.

Parent Name or Initials

Enter the name or initials of the patient's parent.

Date of Birth of Parent

Enter the date of birth of the patient's parent.

Age of Parent

Represents the age of the parent at the time of the adverse event or reaction. This value is autocalculated by the system based on the specified date of the patient's birth and considering the Onset Date/Time value set in the Events form.

To amend the value, select the Manual checkbox.

Age of Parent (Unit)

Represents the unit to measure the age of the patient's parent. For the autocalculated Age of Parent value, the unit is also autopopulated by the system.

To amend the value, select the Manual checkbox.

Manual

Select this checkbox next to both the Age of Parent or Age of Parent (Unit) fields to change their value manually disabling the autocalculation functionality.

Weight of Parent

Enter the weight of the patient's parent.

Weight Unit of Parent

Select the unit to measure the weight of the patient's parent.

Height of Parent

Enter the height of the patient's parent.

Height Unit of Parent

Select the unit to measure the height of the patient's parent.

Sex of Parent

Select the sex of the patient's parent.

Last Menstrual Period Date of Parent

Represents the date when the last menstrual cycle of the patient's parent has ended.

This field is enabled only if the sex of the parent is female.

SAVE

Select to save the implemented changes of the Parent form.

Verbatim Term

Select to chose the MedDRA LLT term for the medical record of the patient's parent. All the details pertaining to the selected term are populated in the corresponding fields of the form and they are disabled by default.

Start Date

Select the date when the reported disease has started.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the start date not to be later than the end date.

Ongoing?

Select the current status of the disease:

End Date

Select the date when the disease has ended.

This field becomes available if the disease is not ongoing anymore (the Ongoing field value is set to No).

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the end date not to be earlier than the start date.

Comments

Enter any auxiliary information or notes related to the reported disease.

Other Relevant Medical History and Concurrent Condition Information of Parent

Enter information about any other medical history for the parent that could not be coded.

Translation

Select next to the form field to translate its value into available languages.

Select this icon to add a new medical record related to the patient's parent. Bear in mind, you can add new records only after saving the form with the previously added medical record.

Product Name*

Enter the product name previously given to the patient's parent. Or select WHODrug to apply WHODrug coding to the existing product.

Start Date

Specify the date when the patient's parent has started taking the indicated drug.

The date can be specified fully or partially, for instance, "01-05-2024" or "01-2024". However, the system validates the start date not to be later than the end date.

End Date

Specify the date when the patient's parent has finished taking the indicated drug.

The date can be specified fully or partially, for instance, "01-05-2024" or "01-2024". However, the system validates the end date not to be earlier than the start date.

Medicinal Product Identifier (MPID)

Enter the definition of the drug as per ISO 11615 Medicinal Product Identification (MPID). This field is inactive if you enter any value in the Pharmaceutical Product Identifier (PhPID) or PhPID Version Date / Number field.

MPID Version

Enter the version of the drug as per ISO 11615 Medicinal Product Identification (MPID). This field is inactive if you enter any value in the Pharmaceutical Product Identifier (PhPID) or PhPID Version Date / Number field.

Pharmaceutical Product Identifier (PhPID)

Enter a unique identifier calculated by an algorithm based on the substance identification (ISO 11238), dosage form (ISO 11239), and strengths with units of measurement (ISO 11240). This field is inactive if you enter any value in the Medicinal Product Identifier (MPID) or MPID Version Date / Number field.

PhPID Version

Enter the version of the pharmaceutical product identifier. This field is inactive if you enter any value in the Medicinal Product Identifier (MPID) or MPID Version Date / Number field.

WHO Drug Version

Represents the version of the World Health Organization (WHO) Drug Dictionary used for coding drug information. The field is read-only and populated via product coding.

WHO Drug Coding Type

Represents the type of coding used for adding the product. The field is read-only and populated via product coding.

WHO Drug Code

Represents a unique identifier for a drug within the WHO Drug Dictionary. The field is read-only and populated via product coding.

WHO MPID

Represents the WHO medical product identifier, which is a unique number assigned to a drug for identification purposes. The field is read-only and populated via product coding.

Trade Name

Enter the trade or brand name of the medicine.

Generic Name

Enter the chemical name of the drug based on the compound's chemical structure.

Trademark Name

Enter the company name that owns the product.

Strength Name

Enter the name of the active ingredient in the drug.

Form Name

Enter one of the common drug dosages, for example, capsules, pills, and so on.

Container Name

Enter the name of the packaging used to store the drug, for example, the bottle.

Device Name

Enter the name of the medical device.

Intended Use Name

Enter the population or condition for which the product is intended to be used, for example, intended for children aged 0-12 months, intended use for heartburn relief, and so on.

Indication

Select MedDRA Search to apply MedDRA term coding for the state of the patient's parent when the drug has been given to them. The details about the selected term are populated in corresponding fields of the form and they are inactive by default.

Reaction

Select MedDRA Search to apply MedDRA term coding for the parent's reaction to the given drug if any. The details about the selected term are populated in corresponding fields of the form and they are inactive by default.

SAVE

Select to save and add the drug to the parent's drug history.

Select this icon to add another drug to the parent's drug history.

Note that you can add new drugs only after saving the previously added drug record.

Substance Name*

Enter the name of the substance in the given drug.

Substance TermID

Enter the ID of the substance in the given drug as per ISO IDMP standards.

Substance TermID Version

Enter the version of the substance in the given drug as per ISO IDMP standards.

Strength

Enter the amount of drug in the given dosage form, for example, 200 mg/tablet.

Strength Unit

Select the unit to measure the strength of the given drug, for example, mg.

Translation

Select next to the form field to translate its value into available languages.

Select this icon to add another drug substance to the parent's drug history.

Note that you can add new drug substances only after saving the previously added one.

Pregnancy Type*

Represents one of the following types of pregnancy:

Number of Fetus

Represents the number of fetuses during the pregnancy.

Trimester of Exposure

Represents the trimester when the pregnant female patient has first been exposed to the suspect drug or device. You can select multiple trimesters if needed.

Pre-Pregnancy Weight

Represents the weight that the woman had before the pregnancy.

Pre-Pregnancy Weight Unit

Represents the unit to measure the woman's pre-pregnancy weight.

Para

Represents the number of times a woman has given birth to a viable child.

Gravida

Represents the number of times a woman has been pregnant, including a current pregnancy.

Pregnancy Ongoing?

Represents the status of the pregnancy, either it is still ongoing or has already finished.

Expected Delivery Date

Represents the date of expected child delivery. Select the date if the child has not yet been born.

End of Pregnancy Date

Represents the date when the pregnancy has come to an end.

Date of Conception

Represents the date when the child has been supposedly conceived.

Pregnancy Diagnosis Method

Represents the method that has been used to identify the fetus in a pregnant woman.

Planned Pregnancy?

Select Yes if the pregnancy has been planned beforehand.

Type of Contraceptives Used

Represents the type of contraceptives that have been used before the child's conceiving.

Contraceptive Failure?

Select Yes if there has been a contraceptive failure that has resulted in pregnancy.

Pregnancy Outcome Known?

Select Yes if the outcome of the pregnancy is already known.

Pregnancy Outcome

Represents the outcome of the pregnancy, for example, live birth or stillbirth.

Delivery Status

Select Not yet delivered or Delivered depending on whether the child has been delivered after the pregnancy. If the Delivered option is selected, the Neonate Information form appears where you can fill in information about the newborn baby or babies.

SAVE

Select to save and update the patient's pregnancy history.

Select this icon to add another pregnancy to the patient's history. Bear in mind, you can add pregnancies only after saving the previously added one.

Delivery Method

Represents the method of how the neonate has been born.

Sex

Represents the sex of the neonate.

Date of Delivery

Represents the date when the neonate has been born.

Weight

Represents the weight of the neonate at birth.

Weight Unit

Represents the unit to measure the weight of the neonate.

Length at Birth

Represents the length of the neonate at birth.

Length at Birth Unit

Represents the unit to measure the length of the neonate.

Head Circumference

Represents the head circumference size of the neonate at birth.

Head Circumference Unit

Represents the unit to measure the head circumference of the neonate.

Birth Outcome

Represents the outcome of the neonate's birth.

APGAR Score#1

Represents a standardized method used to quickly assess the physical condition of a newborn baby. The score is based on five parameters that are evaluated one minute after birth: skin color, heart rate, reflex irritability, muscle tone, and breathing effort. Each parameter is assigned a score of 0, 1, or 2, with a maximum possible score of 10.

APGAR Score#5

Represents a standardized method used to quickly assess the physical condition of a newborn baby. The score is based on five parameters that are evaluated five minutes after birth: skin color, heart rate, reflex irritability, muscle tone, and breathing effort. Each parameter is assigned a score of 0, 1, or 2, with a maximum possible score of 10.

APGAR Score#10

Represents a standardized method used to assess the physical condition of a newborn baby. The score is based on five parameters that are evaluated ten minutes after birth: skin color, heart rate, reflex irritability, muscle tone, and breathing effort. Each parameter is assigned a score of 0, 1, or 2, with a maximum possible score of 10.

APGAR Score#30

Represents a standardized method used to assess the physical condition of a newborn baby. The score is based on five parameters that are evaluated thirty minutes after birth: skin color, heart rate, reflex irritability, muscle tone, and breathing effort. Each parameter is assigned a score of 0, 1, or 2, with a maximum possible score of 10.

Select this icon to add another neonate to the patient's pregnancy history. Bear in mind, you can add neonates only after saving the previously added one.

Event Verbatim

Select to perform the manual coding according to MedDRA for the occurred event. All the details pertaining to the selected Lowest Level Term (LLT) term are populated in the corresponding fields of the form and they are disabled by default.

Event Verbatim(Native)

Enter the original words or short phrases used by the reporter to describe the reaction/event in the native language it is received if it is other than English.

This value along with CRF AE# and Onset Date/Time form a combination of parameters required to recognize the case imported from EDC as the same ICSR follow-up version.

Native Language*

Select the native language in which the event has been reported.

CRF AE#

Enter the sequential number of the AE/SAE record in EDC.

This value along with Event Verbatim(Native) and Onset Date/Time form a combination of parameters required to recognize the case imported from EDC as the same ICSR follow-up version.

Event Verbatim Translation

Represents the verbatim in the native language reported by the reporter.

Severity by Reporter

Select one of the options to indicate how the reporter of the event has assessed the degree of intensity or seriousness of this event as follows.

Term Highlighted by the Reporter

Represents the term of an adverse reaction or event that the primary source indicated was a major concern or reason for reporting the case. This field can be used to indicate the specific diagnosis that has been identified by the reporter.

CTCAE Grade

Represents the grade on the scale of the Common Terminology Criteria for Adverse Events system.

CTCAE Version

Represents the version of the Common Terminology Criteria for Adverse Events system that has been used to grade the reported event.

Was the Adverse Event Serious?*

Select one of the following:

Results in Death*

Select one of the following:

Life Threatening*

Select one of the following:

Caused / Prolonged Hospitalization*

Select one of the following:

Caused Hospitalisation

Select one of the following:

This field is available only if it has been mentioned that the event has caused any hospitalization.

Prolonged Hospitalisation

Select one of the following:

This field is available only if it has been mentioned that the event has caused any hospitalization.

Disabling / Incapacitating*

Select one of the following:

Disabling

Select one of the following:

This field is available only if it has been mentioned that the event has caused any disability.

Incapacitating

Select one of the following:

This field is available only if it has been mentioned that the event has caused any disability.

Congenital Anomaly / Birth Defect*

Select one of the following:

Important Medical Event*

Select one of the following:

Hospitalisation Start Date

Represents the date when the patient has been hospitalized.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the start date not to be later than the end date.

This field is available only if it has been mentioned that the event has caused the patient's hospitalization.

Hospitalisation End Date

Represents the date when the patient has been released from the hospital.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the end date not to be earlier than the start date.

This field is available only if it has been mentioned that the event has caused the patient's hospitalization.

Number of Days Hospitalized

Represents the number of days the patient has been hospitalized. This value is autocalculated by the system as the difference between the dates specified in the Hospitalisation Start Date and Hospitalisation End Date fields.

The autocalculation happens upon saving the form with specified Hospitalisation Start Date and Hospitalisation End Date values.

To amend the value, select the Manual checkbox.

Manual

Select this checkbox next to the Number of Days Hospitalized field to change the value manually disabling the autocalculation functionality.

Hospital Name

Represents the name of the hospital where the patient has been admitted.

This field is available only if it has been mentioned that the event has caused the patient's hospitalization.

Hospital City

Represents the city where the hospital is located.

This field is available only if it has been mentioned that the event has caused the patient's hospitalization.

Hospital State

Represents the state where the hospital is located. This field is available only if it has been mentioned that the event has caused the patient's hospitalization.

Date AE Became Serious

Represents the date when the adverse event has become serious.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024."

Onset Date/Time

Represents the date when the adverse reaction or event has started.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the start date not to be later than the end date.

This value along with Event Verbatim(Native) and CRF AE# form a combination of parameters required to recognize the case imported from EDC as the same ICSR follow-up version.

Stop Date/Time

Represents the date when the adverse reaction or event has ended.

The date can be specified fully or partially, for instance, "01.05.2024" or "01.2024." However, the system validates the end date not to be earlier than the start date.

Duration

Represents the time interval of the adverse reaction or event occurrence. This value is autocalculated by the system as the difference between the dates specified in the Onset Date/Time and Stop Date/Time fields.

The autocalculation happens upon saving the form with specified Onset Date/Time and Stop Date/Time values.

To amend the value, select the Manual checkbox.

Duration Unit

Represents the time unit to measure the adverse reaction or event occurrence.

The autocalculation happens upon saving the form with specified Onset Date/Time and Stop Date/Time values.

To amend the value, select the Manual checkbox.

Manual

Select this checkbox next to both the Duration and Duration Unit fields to change their values manually disabling the autocalculation functionality.

Outcome of Reaction / Event at the Time of Last Observation*

Represents the outcome of the adverse reaction or event at the time of the last patient's observation, for example, resolved or recovering.

If Not Resolved, Stable or Not Stable?

Represents the current health status of the patient if the reaction or event is still ongoing.

This field is available only if the Not Recovered/Not Resolved/Ongoing option has been selected in the previous field.

Specify Sequelae

Represents the description of health complications in the patient who experienced an adverse reaction or event.

This field is available only if the Recovered/Resolved With Sequelae option has been selected in the previous field.

Medical Confirmation by Healthcare Professional?

Select Yes if the adverse event in the patient has been confirmed by a healthcare professional. If the event is only reported but not confirmed by a healthcare professional, do not select any value in this field.

Country Where the Reaction / Event Occurred

Represents the country where the patient has experienced the adverse reaction or event.

Investigator Awareness Date

Represents the date when the study investigator has become aware of the event.

Related to Study Procedure(s)?

Select one of the following:

If the Event is Not Study Procedure Related, Provide an Alternative Cause Below:

Represents the description of the event if it is not related to the study procedures.

This field is available only if No has been selected in the previous field.

Type of AE (Check all that apply)

Represents the type of adverse event, for example, SAE or infusion-related. You can select multiple options in this field.

Treatment Received?

Select one of the following:

SAE Description

Represents the description of the serious adverse event in the reported case.

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select to save the implemented changes.

Select this icon to add a new event. Bear in mind, that you can add new events only after saving the previously added one.

First Dose Latency

Represents the interval between the first time the product has been administered and the first onset of the adverse reaction or event. The value is autocalculated by the system as the difference between dates specified in the Onset Date field of the respective record in the Events form and the First Dose field of the respective drug record in the Products form.

To amend the value, select the Manual checkbox.

First Dose Latency Unit

Represents the time unit to measure the interval between the first time the product has been administered and the first onset of the adverse reaction or event. For the autocalculated First Dose Latency value, the unit is also updated automatically.

To amend the value, select the Manual checkbox.

Last Dose Latency

Represents the interval between the last time the product has been administered and the onset of the adverse reaction or event. The value is autocalculated by the system as the difference between dates specified in the Onset Date field of the respective record in the Events form and the Last Dose field of the respective drug record in the Products form.

To amend the value, select the Manual checkbox.

Last Dose Latency Unit

Represents the time unit to measure the interval between the last time the product has been administered and the onset of the adverse reaction or event. For the autocalculated Last Dose Latency value, the unit is also updated automatically.

To amend the value, select the Manual checkbox.

Manual

Dechallenge Results

If the suspect product has been stopped or interrupted or the dose has been reduced, identify if the AE diminished—lessened in degree or intensity, including its complete disappearance. To identify, select the needed option as follows.

Dechallenge Date

Select the date when the drug has been withdrawn or stopped.

Rechallenge Results

Identify whether the AE reappeared if the suspect product was reintroduced by selecting the appropriate result (response) as follows.

Start Date/Time

Select the date when the drug has been reintroduced.

Stop Date/Time

Select the date when the reintroduced drug has been withdrawn again.

Event Expectedness

The field is populated with Unexpected or Expected values based on the event expectedness for the product according to the data sheet revision number. To populate values to the field, select Generate Record .

Causality As Reported

Represents the reported result of causality assessment automatically populated by the system based on the Causality Assessment block values of the Assessment form of your ICSR. The calculation follows the configured rules.

The autocalculation rules can be configured according to customer requirements by the EDETEK administrator.

The currently configured rules are found in Appendix B. Causality as reported rules.

Causality As Determined

The field is read-only and represents the result of company causality automatically populated by the system based on the Causality Assessment block values according to configured rules.

The autocalculation rules can be configured according to customer requirements by the EDETEK administrator.

The currently configured rules are found in Appendix C. Causality as determined rules.

Generate Record

Select to tie the product that has been flagged as suspect to all of the reported events.

SAVE

Select to save the implemented changes.

Method of Assessment*

Select the method of how the assessment has been conducted.

This field becomes inactive if the assessment method is specified in the Method Text field because these fields are alternative and data can be specified only in one or the other, but not simultaneously.

Source of Assessment*

Select the stakeholder who has conducted the assessment.

This field becomes inactive if the source of assessment is specified in the Source Text field because these fields are alternative and data can be specified only in one or the other, but not simultaneously.

Result of Assessment*

Select the outcome of the assessment conducted to identify whether adverse reactions or events are related to the product flagged as suspect.

The causality autocalculation rules can be configured according to customer requirements by the EDETEK administrator. The currently configured rules can be found in Appendix D. Case causality rules.

This field becomes inactive if the result of assessment is specified in the Result Text field because these fields are alternative and data can be specified only in one or the other, but not simultaneously.

Method Text

Enter a free-text description of the method of how the assessment has been conducted. This field is mostly used to enter the unmapped details manually upon data migration.

This field becomes inactive if the assessment method is specified in the Method of Assessment field because these fields are alternative and data can be specified only in one or the other, but not simultaneously.

Source Text

Enter a free-text description of the stakeholder who has conducted the assessment. This field is mostly used to enter the unmapped details manually upon data migration.

Note that:

Result Text

Enter a free-text outcome of the assessment conducted to identify whether adverse reactions or events are related to the product flagged as suspect. This field is mostly used to enter the unmapped details manually upon data migration.

Note that:

If NOT RELATED, Provide an Alternative Cause Below

Enter the assessment description if the stakeholder has determined that adverse reactions or events are not related to the product flagged as suspect.

Select this icon to add a new causality assessment record.

Note that you can add new causality assessment records only after saving the previously added one.

Case Narrative*

There are two options for adding a narrative:

Reporter's Comments

There are two options for adding reporter's comments:

Company's Comments

There are two options for adding reporter's comments:

Translation

Select next to the form field to translate its value into available languages.

SAVE

Select SAVE to save the implemented changes.

Company's Diagnosis / Syndrome and / or Reclassification of Reaction / Event

Select MedDRA Search to choose the MedDRA LLT term that combines the company assessment with the signs and symptoms that have been reported into a succinct diagnosis. All the details of the selected LLT term are populated in the corresponding fields of the form and they are disabled by default.

Select this icon in the Company Diagnosis block, to add a new patient's diagnosis that is related to the occurred event. Bear in mind, that you can add new diagnoses only after saving the previously added one.

Case Summary and Reporter's Comments Language*

Represents the language used by the case reporter to record his findings pertaining to the adverse reaction or event.

Case Summary and Reporter's Comments Text*

Represents information on the clinical course of the case, therapeutic measures, outcome, and other relevant information, as well as the reporter's comments on the case in a language different from the one used in the Case Narrative, Reporter's Comments, and Company's Comments fields.

Select the plus icon in the Native Narrative block, to add a new native narrative record. Bear in mind, you can add new native narrative records only after saving the previously added one.

Source Document File*

Select the designated area and choose the file on your computer to upload. Alternatively, drag your file to the designated area. Based on the file size, you might need to wait for the system to complete the upload.

The source materials must be in the following formats: DOC, DOCX, PDF, XLS, XLSX, or TXT.

Source Document Description*

Enter a description of the uploaded document to elaborate on its specifics.

Type

Select the type of the document being uploaded.

Note that when the file type is the same as the selected type in which the submission destination is used for exporting E2B R3 XML, the matched source file is to be exported into the submission package.

SAVE

Select to save the implemented changes.

Refresh

Select to discard your changes and clear all fields.

Download

Select to download the source file.

Delete

Select to remove the uploaded source file from the form.

New

Once the form is saved, select to add a new form where you can upload another source file.

Case Relationship Type*

Select the relationship of the case to the one that is to be linked: Other Case Identifiers in Previous Transmissions, Local Reference No., or Linked to This Report.

Source(s) of the Case Identifier

Represents all the involved entities (for example, organizations) that have contributed sources of information for this ICSR and have their corresponding case identifiers. This field is available only if the Other Case Identifiers in Previous Transmissions case relationship type is selected.

Case Identifier(s)

Represents the source case identifiers. This field is available only if the Other Case Identifiers in Previous Transmissions case relationship type is selected.

Identification Number of the Report Which is Linked to this Report

Represents an identifier of another report or case that warrants being evaluated together with this ICSR. This field is available only if the Linked to This Report case relationship type is selected.

Link Reason

Represents the reason for the case linking. This field is available only if the Linked to This Report case relationship type is selected.

Notes

Represents the name of the source where the linked ICSR is located. This field is available only if the Local Reference No. case relationship type is selected.

Number

Represents the case report ID in the source location indicated previously. This field is available only if the Local Reference No. case relationship type is selected.

Select this icon to add a new linked record to the ICSR. Bear in mind, that you can add new linked records only after saving the previously added one.

SAVE

Select to save the implemented changes.