Create ICSR Case

curl --request POST \
  --url https://api.example.com/api/v1/icsr \
  --header 'Content-Type: application/json' \
  --data '
{
  "paciente_iniciales": "<string>",
  "paciente_edad": 123,
  "paciente_sexo": "<string>",
  "reportante_nombre": "<string>",
  "producto_sospechoso": "<string>",
  "descripcion_evento": "<string>",
  "paciente_peso": 123,
  "paciente_dni": "<string>",
  "paciente_fecha_nacimiento": "<string>",
  "paciente_grupo_etareo": "<string>",
  "paciente_diagnostico_principal": "<string>",
  "paciente_cie10": "<string>",
  "paciente_comorbilidades": "<string>",
  "paciente_gestacion_meses_raw": "<string>",
  "reportante_contacto": "<string>",
  "reportante_email": "<string>",
  "reportante_telefono": "<string>",
  "reportante_ocupacion": "<string>",
  "fecha_inicio_evento": "<string>",
  "fecha_fin_evento": "<string>",
  "gravedad": "<string>",
  "ea_causalidad": "<string>",
  "ea_desenlace": "<string>",
  "ea_grave_solo_ram": true,
  "estado": "<string>",
  "numero": "<string>",
  "tipo_notificacion": "<string>",
  "fuente_notificacion": "<string>",
  "doc_fuente_url": "<string>",
  "codigo_interno_lab": "<string>",
  "cenafyt_codigo": "<string>",
  "productos": [
    {
      "nombre_producto": "<string>",
      "ifa": "<string>",
      "forma_farmaceutica": "<string>",
      "laboratorio_pais": "<string>",
      "registro_sanitario": "<string>",
      "nro_lote": "<string>",
      "via_administracion": "<string>",
      "dosis_frecuencia": "<string>",
      "fecha_inicio": "<string>",
      "fecha_fin": "<string>",
      "desaparecio_al_suspender": "<string>",
      "desaparecio_al_disminuir_dosis": "<string>",
      "reaparecio_reexposicion": "<string>",
      "antecedente_reaccion": "<string>",
      "paciente_recibio_tratamiento_ram": "<string>",
      "detalle_tratamiento_ram": "<string>"
    }
  ],
  "concomitantes": [
    {
      "nombre_producto": "<string>",
      "dosis_frecuencia": "<string>",
      "nro_lote": "<string>",
      "via_administracion": "<string>",
      "fecha_inicio": "<string>",
      "fecha_fin": "<string>",
      "motivo_prescripcion": "<string>"
    }
  ],
  "seguimientos": [
    {
      "numero": 123,
      "fecha": "<string>",
      "comentarios": "<string>"
    }
  ],
  "lt_fecha_recibido_colaborador": "<string>",
  "lt_fecha_recibido_ufv": "<string>",
  "lt_dias_colab_ufv": 123,
  "lt_fecha_limite_digemid": "<string>",
  "lt_fecha_envio_digemid": "<string>",
  "lt_dias_ufv_digemid": 123,
  "lt_comentarios_no_sometimiento": "<string>",
  "lt_problemas_adicionales": "<string>",
  "qc_realizado_por": "<string>",
  "qc_fecha": "<string>",
  "revision_senales": "<string>",
  "comentarios_adicionales": "<string>",
  "seg_contactar_paciente": true,
  "seg_adicional_fecha": "<string>",
  "seg_adicional_comentarios": "<string>",
  "seg_adicional_estado": "<string>"
}
'

{
  "id": 123,
  "created_at": "<string>",
  "paciente_iniciales": "<string>",
  "paciente_edad": 123,
  "producto_sospechoso": "<string>",
  "descripcion_evento": "<string>",
  "productos": [
    {}
  ],
  "concomitantes": [
    {}
  ],
  "seguimientos": [
    {}
  ],
  "eventos": [
    {}
  ]
}

POST

api

icsr

Create ICSR Case

curl --request POST \
  --url https://api.example.com/api/v1/icsr \
  --header 'Content-Type: application/json' \
  --data '
{
  "paciente_iniciales": "<string>",
  "paciente_edad": 123,
  "paciente_sexo": "<string>",
  "reportante_nombre": "<string>",
  "producto_sospechoso": "<string>",
  "descripcion_evento": "<string>",
  "paciente_peso": 123,
  "paciente_dni": "<string>",
  "paciente_fecha_nacimiento": "<string>",
  "paciente_grupo_etareo": "<string>",
  "paciente_diagnostico_principal": "<string>",
  "paciente_cie10": "<string>",
  "paciente_comorbilidades": "<string>",
  "paciente_gestacion_meses_raw": "<string>",
  "reportante_contacto": "<string>",
  "reportante_email": "<string>",
  "reportante_telefono": "<string>",
  "reportante_ocupacion": "<string>",
  "fecha_inicio_evento": "<string>",
  "fecha_fin_evento": "<string>",
  "gravedad": "<string>",
  "ea_causalidad": "<string>",
  "ea_desenlace": "<string>",
  "ea_grave_solo_ram": true,
  "estado": "<string>",
  "numero": "<string>",
  "tipo_notificacion": "<string>",
  "fuente_notificacion": "<string>",
  "doc_fuente_url": "<string>",
  "codigo_interno_lab": "<string>",
  "cenafyt_codigo": "<string>",
  "productos": [
    {
      "nombre_producto": "<string>",
      "ifa": "<string>",
      "forma_farmaceutica": "<string>",
      "laboratorio_pais": "<string>",
      "registro_sanitario": "<string>",
      "nro_lote": "<string>",
      "via_administracion": "<string>",
      "dosis_frecuencia": "<string>",
      "fecha_inicio": "<string>",
      "fecha_fin": "<string>",
      "desaparecio_al_suspender": "<string>",
      "desaparecio_al_disminuir_dosis": "<string>",
      "reaparecio_reexposicion": "<string>",
      "antecedente_reaccion": "<string>",
      "paciente_recibio_tratamiento_ram": "<string>",
      "detalle_tratamiento_ram": "<string>"
    }
  ],
  "concomitantes": [
    {
      "nombre_producto": "<string>",
      "dosis_frecuencia": "<string>",
      "nro_lote": "<string>",
      "via_administracion": "<string>",
      "fecha_inicio": "<string>",
      "fecha_fin": "<string>",
      "motivo_prescripcion": "<string>"
    }
  ],
  "seguimientos": [
    {
      "numero": 123,
      "fecha": "<string>",
      "comentarios": "<string>"
    }
  ],
  "lt_fecha_recibido_colaborador": "<string>",
  "lt_fecha_recibido_ufv": "<string>",
  "lt_dias_colab_ufv": 123,
  "lt_fecha_limite_digemid": "<string>",
  "lt_fecha_envio_digemid": "<string>",
  "lt_dias_ufv_digemid": 123,
  "lt_comentarios_no_sometimiento": "<string>",
  "lt_problemas_adicionales": "<string>",
  "qc_realizado_por": "<string>",
  "qc_fecha": "<string>",
  "revision_senales": "<string>",
  "comentarios_adicionales": "<string>",
  "seg_contactar_paciente": true,
  "seg_adicional_fecha": "<string>",
  "seg_adicional_comentarios": "<string>",
  "seg_adicional_estado": "<string>"
}
'

{
  "id": 123,
  "created_at": "<string>",
  "paciente_iniciales": "<string>",
  "paciente_edad": 123,
  "producto_sospechoso": "<string>",
  "descripcion_evento": "<string>",
  "productos": [
    {}
  ],
  "concomitantes": [
    {}
  ],
  "seguimientos": [
    {}
  ],
  "eventos": [
    {}
  ]
}

Endpoint

POST /api/v1/icsr

Authentication

Requires permission: icsr:create

Request Body

Required Fields

paciente_iniciales

string

required

Patient initials (e.g., “JD” for John Doe)

paciente_edad

integer

required

Patient age in years

paciente_sexo

string

required

Patient sex: “M” (male), “F” (female), or “O” (other)

reportante_nombre

string

required

Name of the person reporting the adverse event

producto_sospechoso

string

required

Name of the suspected product causing the adverse event

descripcion_evento

string

required

Detailed narrative description of the adverse event

Patient Information

paciente_peso

number

Patient weight in kilograms

paciente_dni

string

Patient identification document number. Aliases: dni, doc_identidad, documento_identidad

paciente_fecha_nacimiento

string

Patient date of birth (ISO format: YYYY-MM-DD)

paciente_grupo_etareo

string

Age group classification (e.g., “Adulto”, “Pediátrico”, “Geriátrico”)

paciente_diagnostico_principal

string

Primary medical diagnosis

paciente_cie10

string

ICD-10 diagnosis code

paciente_comorbilidades

string

Comorbidities and relevant medical history

paciente_gestacion_meses_raw

string

Pregnancy status in months. Accepts numeric values, “No aplica”, or “Desconocido”

Reporter Information

reportante_contacto

string

Reporter contact information (phone or email). System will auto-detect and populate reportante_email or reportante_telefono fields.

reportante_email

string

Reporter email address

reportante_telefono

string

Reporter phone number

reportante_ocupacion

string

Reporter occupation/profession

Event Information

fecha_inicio_evento

string

Date when the adverse event started. Aliases: fecha_inicio, ea_fecha_inicio, evento_fecha_inicio

fecha_fin_evento

string

Date when the adverse event resolved. Aliases: fecha_fin, ea_fecha_fin, evento_fecha_fin

gravedad

string

Event severity classification (e.g., “Grave”, “No grave”)

ea_causalidad

string

Causality assessment. Alias: causalidad

ea_desenlace

string

Event outcome. Alias: desenlace. Common values: “Recuperado”, “En recuperación”, “Secuelas”, “Muerte”, “Desconocido”

ea_grave_solo_ram

boolean

Whether the event is serious only due to the adverse reaction

Case Metadata

estado

string

Case status (e.g., “Pendiente”, “En progreso”, “Cerrado”)

numero

string

Case number or identifier

tipo_notificacion

string

Notification type (e.g., “Inicial”, “Seguimiento”)

fuente_notificacion

string

Source of notification (e.g., “Profesional de salud”, “Paciente”, “Farmacéutico”)

doc_fuente_url

string

URL to source document or attachment

codigo_interno_lab

string

Laboratory internal code

cenafyt_codigo

string

CENAFYT reference code

Product Arrays

productos

array

Array of suspected products. Each product includes:

Show Product Object Schema

nombre_producto

string

required

Product name

ifa

string

Active pharmaceutical ingredient (API/IFA)

forma_farmaceutica

string

Pharmaceutical form (e.g., “Tableta”, “Jarabe”, “Inyectable”)

laboratorio_pais

string

Manufacturer/laboratory and country. Aliases: fabricante_pais, fabricantePais, pais_fabricante

registro_sanitario

string

Sanitary registration number. Alias: registroSanitario

nro_lote

string

Batch/lot number. Alias: lote

via_administracion

string

Route of administration. Alias: via

dosis_frecuencia

string

Dosage and frequency (e.g., “500mg cada 8 horas”)

fecha_inicio

string

Product start date

fecha_fin

string

Product end date

desaparecio_al_suspender

string

Did the event resolve upon discontinuation? Values: “si”, “no”, “no_aplica”

desaparecio_al_disminuir_dosis

string

Did the event resolve with dose reduction? Values: “si”, “no”, “no_aplica”

reaparecio_reexposicion

string

Did the event recur upon rechallenge? Values: “si”, “no”, “no_aplica”

antecedente_reaccion

string

History of previous reaction? Values: “si”, “no”, “no_aplica”

paciente_recibio_tratamiento_ram

string

Did patient receive treatment for the adverse reaction? Values: “si”, “no”, “no_aplica”

detalle_tratamiento_ram

string

Treatment details. Alias: detalle_tratamiento

concomitantes

array

Array of concomitant medications. Each entry includes:

Show Concomitant Medication Schema

nombre_producto

string

required

Product name

dosis_frecuencia

string

Dosage and frequency

nro_lote

string

Batch number

via_administracion

string

Route of administration. Alias: via

fecha_inicio

string

Start date

fecha_fin

string

End date

motivo_prescripcion

string

Reason for prescription. Alias: motivo

seguimientos

array

Array of followup entries. Alias: seguimiento, seguimiento_items. Each entry includes:

Show Followup Entry Schema

numero

integer

Followup number/sequence

fecha

string

Followup date

comentarios

string

Followup comments/notes

Timeline Fields

lt_fecha_recibido_colaborador

string

Date received by collaborator

lt_fecha_recibido_ufv

string

Date received by pharmacovigilance unit (UFV)

lt_dias_colab_ufv

integer

Days between collaborator receipt and UFV receipt

lt_fecha_limite_digemid

string

DIGEMID submission deadline. Alias: lt_fecha_limite_envio_digemid

lt_fecha_envio_digemid

string

Actual DIGEMID submission date

lt_dias_ufv_digemid

integer

Days between UFV receipt and DIGEMID submission

lt_comentarios_no_sometimiento

string

Comments if not submitted to DIGEMID

lt_problemas_adicionales

string

Additional timeline problems or notes

Quality Control

qc_realizado_por

string

QC performed by (user/reviewer name). Alias: cc_realizado_por

qc_fecha

string

QC date

revision_senales

string

Signal detection review notes

comentarios_adicionales

string

Additional comments

Followup Settings

seg_contactar_paciente

boolean

Whether patient wishes to be contacted. Alias: paciente_desea_contacto

seg_adicional_fecha

string

Additional followup date

seg_adicional_comentarios

string

Additional followup comments

seg_adicional_estado

string

Additional followup status

Response

integer

Unique ICSR identifier assigned by the system

created_at

string

Timestamp when the case was created

paciente_iniciales

string

Patient initials

paciente_edad

integer

Patient age

producto_sospechoso

string

Suspected product

descripcion_evento

string

Event description

productos

array

Array of product objects with id field added

concomitantes

array

Array of concomitant medication objects with id field added

seguimientos

array

Array of followup objects with id field added

eventos

array

Array of adverse event objects (initially empty for new cases)

Behavior

Auto-Processing

When a new ICSR is created:

Contact Auto-Detection: If reportante_contacto contains ”@”, it’s copied to reportante_email. Otherwise, it’s copied to reportante_telefono.
Internal Notifications: Configured users receive email notification based on environment variables:
- ICSR_NOTIFY_CARGOS - Job titles to notify
- ICSR_NOTIFY_AREAS - Department areas to notify
- ICSR_NOTIFY_EMAILS - Additional email addresses
Missing Data Auto-Reply: If reporter email is available and required fields are missing, an automatic followup email is sent requesting additional information.
Duplicate Detection: Background duplicate detection runs automatically comparing against existing cases.

Validation

The API validates:

Required fields are present
Data types match schema
Date formats are ISO-8601 (YYYY-MM-DD)
Nested arrays contain valid objects
Field lengths don’t exceed limits

Example Request

{
  "paciente_iniciales": "JD",
  "paciente_edad": 45,
  "paciente_sexo": "M",
  "paciente_peso": 72.5,
  "paciente_dni": "12345678",
  "paciente_fecha_nacimiento": "1978-03-15",
  "reportante_nombre": "Dr. Maria Garcia",
  "reportante_email": "mgarcia@hospital.com",
  "reportante_ocupacion": "Médico",
  "producto_sospechoso": "Amoxicilina 500mg",
  "descripcion_evento": "Paciente desarrolló rash eritematoso generalizado 3 días después de iniciar tratamiento con amoxicilina para infección respiratoria. El rash fue pruriginoso y se resolvió 48 horas después de suspender el antibiótico.",
  "fecha_inicio_evento": "2024-01-15",
  "fecha_fin_evento": "2024-01-18",
  "gravedad": "No grave",
  "ea_causalidad": "Probable",
  "ea_desenlace": "Recuperado",
  "estado": "Pendiente",
  "tipo_notificacion": "Inicial",
  "fuente_notificacion": "Profesional de salud",
  "productos": [
    {
      "nombre_producto": "Amoxicilina",
      "ifa": "Amoxicilina trihidratada",
      "forma_farmaceutica": "Tableta",
      "laboratorio_pais": "Laboratorio ABC - Perú",
      "registro_sanitario": "EE-123456",
      "nro_lote": "LOT2024-001",
      "via_administracion": "Oral",
      "dosis_frecuencia": "500mg cada 8 horas",
      "fecha_inicio": "2024-01-12",
      "fecha_fin": "2024-01-16",
      "desaparecio_al_suspender": "si",
      "reaparecio_reexposicion": "no_aplica"
    }
  ],
  "concomitantes": [
    {
      "nombre_producto": "Paracetamol",
      "dosis_frecuencia": "500mg PRN",
      "via_administracion": "Oral",
      "motivo_prescripcion": "Fiebre"
    }
  ]
}

Example Response

{
  "id": 1234,
  "created_at": "2024-01-20T10:30:00Z",
  "paciente_iniciales": "JD",
  "paciente_edad": 45,
  "paciente_sexo": "M",
  "paciente_peso": 72.5,
  "paciente_dni": "12345678",
  "paciente_fecha_nacimiento": "1978-03-15",
  "reportante_nombre": "Dr. Maria Garcia",
  "reportante_email": "mgarcia@hospital.com",
  "reportante_ocupacion": "Médico",
  "producto_sospechoso": "Amoxicilina 500mg",
  "descripcion_evento": "Paciente desarrolló rash eritematoso generalizado...",
  "fecha_inicio_evento": "2024-01-15",
  "fecha_fin_evento": "2024-01-18",
  "gravedad": "No grave",
  "ea_causalidad": "Probable",
  "ea_desenlace": "Recuperado",
  "estado": "Pendiente",
  "tipo_notificacion": "Inicial",
  "fuente_notificacion": "Profesional de salud",
  "productos": [
    {
      "id": 5678,
      "nombre_producto": "Amoxicilina",
      "ifa": "Amoxicilina trihidratada",
      "forma_farmaceutica": "Tableta",
      "laboratorio_pais": "Laboratorio ABC - Perú",
      "registro_sanitario": "EE-123456",
      "nro_lote": "LOT2024-001",
      "via_administracion": "Oral",
      "dosis_frecuencia": "500mg cada 8 horas",
      "fecha_inicio": "2024-01-12",
      "fecha_fin": "2024-01-16",
      "desaparecio_al_suspender": "si",
      "reaparecio_reexposicion": "no_aplica"
    }
  ],
  "concomitantes": [
    {
      "id": 9012,
      "nombre_producto": "Paracetamol",
      "dosis_frecuencia": "500mg PRN",
      "via_administracion": "Oral",
      "motivo_prescripcion": "Fiebre"
    }
  ],
  "seguimientos": [],
  "eventos": []
}

Error Responses

400 Bad Request

{
  "detail": [
    {
      "loc": ["body", "paciente_iniciales"],
      "msg": "field required",
      "type": "value_error.missing"
    }
  ]
}

401 Unauthorized

{
  "detail": "Not authenticated"
}

403 Forbidden

{
  "detail": "Permission denied: icsr:create required"
}

Notes

The system automatically creates audit log entries for case creation
Duplicate detection runs asynchronously and doesn’t block case creation
Internal codes can be auto-generated using /api/v1/icsr/codigo-interno/next
Product registration data is automatically enriched from the product catalog if registro_sanitario matches an existing product

ICSR API Overview

List ICSR Cases

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Authentication

ICSR

IPS Reports

Document Management

Surveillance

OCR & NLP

Products & MedDRA

Create ICSR Case

Endpoint

Authentication

Request Body

Required Fields

Patient Information

Reporter Information

Event Information

Case Metadata

Product Arrays

Timeline Fields

Quality Control

Followup Settings

Response

Behavior

Auto-Processing

Validation

Example Request

Example Response

Error Responses

400 Bad Request

401 Unauthorized

403 Forbidden

Notes

Build docs developers (and LLMs) love

Authentication

ICSR

IPS Reports

Document Management

Surveillance

OCR & NLP

Products & MedDRA

Documentation Index

​Endpoint

​Authentication

​Request Body

​Required Fields

​Patient Information

​Reporter Information

​Event Information

​Case Metadata

​Product Arrays

​Timeline Fields

​Quality Control

​Followup Settings

​Response

​Behavior

​Auto-Processing

​Validation

​Example Request

​Example Response

​Error Responses

​400 Bad Request

​401 Unauthorized

​403 Forbidden

​Notes

Build docs developers (and LLMs) love

Endpoint

Authentication

Request Body

Required Fields

Patient Information

Reporter Information

Event Information

Case Metadata

Product Arrays

Timeline Fields

Quality Control

Followup Settings

Response

Behavior

Auto-Processing

Validation

Example Request

Example Response

Error Responses

400 Bad Request

401 Unauthorized

403 Forbidden

Notes