Structured Data Capture
3.0.0 - STU 3
Structured Data Capture
3.0.0 - STU 3
Structured Data Capture, published by HL7 International / FHIR Infrastructure. This guide is not an authorized publication; it is the continuous build for version 3.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/sdc/ and changes regularly. See the Directory of published versions
Bundle questionnaire-sdc-profile-example of type collection
Entry 1 - fullUrl = http://AHRQ.org/form/Questionnaire/F8-1.2
Resource Questionnaire:
LinkId Text Cardinality Type Description & Constraints MedicationOrOtherSubstances
Questionnaire http://hl7.org/fhir/uv/sdc/Questionnaire/F8-1.2 Medication/header
null 0..1 group Medication/DE2
Event ID: 1..1 string Initial Report Date (HERF Q1) 1..1 string Medication or Other Substance 0..1 group Medication/SEC00.0
Use this form to report any patient safety event or unsafe condition involving a substance such as a medications, biological products, nutritional products, expressed human breast milk, medical gases, or contrast media. Do not complete this form if the event involves appropriateness of therapeutic choice or decision making (e.g., physician decision to prescribe medication despite known drug-drug interaction). If the event involves a device, please also complete the Device or Medical/Surgical Supply including Health Information Technology (HIT) form. Narrative detail can be captured on the Healthcare Event Reporting Form (HERF). 0..1 display null 1..1 group Medication/DE270
What type of medication/substance was involved? 1..1 open-choice Definition: http://AHRQ.gov/data_element_identifier#Type%20of%20substance%20involved
Value Set: D1e551vsWhat type of medication? 1..1 open-choice Definition: http://AHRQ.gov/data_element_identifier#Type%20of%20medication%20involved
Value Set: D1e639vsPlease list all ingredients: 0..* string Definition: http://AHRQ.gov/data_element_identifier#Compounded%20preparation%20ingredients What type of biological product? 0..1 open-choice Value Set: D1e910vs What was the lot number of the vaccine? 1..1 string What type of nutritional product? 1..1 open-choice Value Set: D1e1125vs Which of the following best characterizes the event? 1..1 open-choice Value Set: D1e1558vs What was the incorrect action? 0..1 open-choice Value Set: D1e746vs Which best describes the incorrect dose(s)? 1..1 open-choice Value Set: D1e863vs Which best describes the incorrect timing? 1..1 open-choice Value Set: D1e2109vs Which best describes the incorrect rate? 1..1 open-choice Value Set: D1e2272vs Which best describes the incorrect strength or concentration? 1..1 open-choice Value Set: D1e2489vs What was the expiration date? 1..1 string Was there a documented history of allergies or sensitivities to the medication/substance administered? 1..1 open-choice Value Set: D1e2768vs What was the contraindication (potential or actual interaction)? 1..1 open-choice Value Set: D1e2928vs At what stage in the process did the event originate, regardless of the stage at which it was discovered? 1..1 open-choice Value Set: D1e3159vs null 0..* group Please provide the following medication details for any medications or other substances directly involved in the event. 0..1 display Generic name or investigational drug name 0..1 string Ingredient 0..1 string Brand name 0..1 string Brand name RXCUI 0..1 string Manufacturer 0..1 string Strength or concentration of product 0..1 string Clinical Component RXCUI 0..1 string Dosage form of Product 0..1 string Dose form RXCUI 0..1 string Was this medication/substance prescribed for this patient? 1..1 open-choice Value Set: D1e4024vs Was this medication/substance given to this patient? 1..1 open-choice Value Set: D1e4118vs null 0..1 group What was the intended route of administration? 1..1 open-choice Value Set: D1e4236vs What was the actual route of administration (attempted or completed)? 1..1 open-choice Value Set: D1e4716vs STOP 0..1 group The form is complete. 0..1 display Thank you for completing these questions. 0..1 group OMB No. 0935-0143 Exp. Date 10/31/2014 Public reporting burden for the collection of information is estimated to average 10 minutes per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer, Attention: PRA, Paperwork Reduction Project (0935-0143), AHRQ, 540 Gaither Road, Room #5036, Rockville, MD 20850. 0..1 display null 0..1 group AHRQ Common Formats - Hospital Version 1.2 - 2012 Medication or Other Substance 0..1 display Documentation for this format
Entry 2 - fullUrl = http://AHRQ.org/form/Questionnaire/HERF-1.2
Resource Questionnaire:
LinkId Text Cardinality Type Description & Constraints Questionnaire http://hl7.org/fhir/uv/sdc/Questionnaire/HERF-1.2 null 0..1 group Event ID 1..1 string Initial Report Date 1..1 string null 0..1 group Report Date 1..1 string What is being reported? 1..1 open-choice Value Set: ValueSet[null] Briefly describe the event that occurred or unsafe condition 1..* string Briefly describe the location where the event occurred or where the unsafe condition exists 1..* string Which of the following categories are associated with the event or unsafe condition? 1..* open-choice Value Set: ValueSet[null] PATIENT INFORMATION (COMPLETE ONLY IF INCIDENT) 0..1 group Enable When: HERF/DE3 = A3 (DE3-cs#A3) Please complete the patient identifiers below. Additional patient information is captured on the Patient Information Form (PIF). (When reporting a perinatal incident that affected a mother and a neonate, please complete the patient identifiers below for the mother (Q8 – Q11) and the neonate (Q12 – Q15). Please also complete a separate PIF for the neonate involved.) 0..1 display Event Discovery Date 1..1 string Event Discovery Time 1..1 string Patient Information (COMPLETE ONLY IF INCIDENT): 0..1 group Enable When: HERF/DE3 = A3 (DE3-cs#A3) Please complete the patient identifiers below. Additional patient information is captured on the Patient Information Form (PIF). (When reporting a perinatal incident that affected a mother and a neonate, please complete the patient identifiers below for the mother (Q8 – Q11) and the neonate (Q12 – Q15). Please also complete a separate PIF for the neonate involved.) 0..1 display Patient's Name 1..1 string Patient's Date of Birth 0..1 string Patient's Medical Record # 1..1 string Patients' Gender 0..1 open-choice Value Set: ValueSet[null] Neonatal Patient Information: 0..1 group COMPLETE ONLY FOR NEONATE AFFECTED BY PERINATAL INCIDENT 0..1 display Is this event a perinatal incident that affected a neonate? 0..1 open-choice Value Set: ValueSet[null] Neonate's Name 0..1 string Neonate's Date of Birth 0..1 string Neonate's Medical Record # 1..1 string Neonate's Gender 1..1 open-choice Value Set: ValueSet[null] REPORT AND EVENT REPORTER INFORMATION 0..1 group Anonymous Reporter 0..1 open-choice Value Set: ValueSet[null] Reporter's Name 1..1 string Telephone Number 1..1 string Email Address 1..1 string Reporter's Job or Position 0..1 string Thank you for completing these questions. 0..1 group OMB No. 0935-0143 Exp. Date 10/31/2014 Public reporting burden for the collection of information is estimated to average 10 minutes per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer, Attention: PRA, Paperwork Reduction Project (0935-0143), AHRQ, 540 Gaither Road, Room #5036, Rockville, MD 20850. 0..1 display null 0..1 group AHRQ Common Formats - Hospital Version 1.2 - 2012 Medication or Other Substance 0..1 display
Entry 3 - fullUrl = http://AHRQ.org/form/Questionnaire/3921052v1.0
Resource Questionnaire:
LinkId Text Cardinality Type Description & Constraints Questionnaire http://hl7.org/fhir/uv/sdc/Questionnaire/3921052v1.0 Mandatory Diagnosis Questions 1..1 group These items must be included when this data is collected for reporting. 0..1 display Date of Current Pathologic Diagnosis 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#62667v3.0 Diagnosis Type 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#3914869v1.0
Value Set: D1e8086vsPrimary Site 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#3914972v1.0 Conditional Diagnosis Questions 0..1 group There are business rules to indicate situations under which these elements should be used on a case report form. 0..1 display Diagnosis Time Point 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2816923v1.0
Value Set: D1e8407vsOptional Diagnosis Questions 0..1 group There is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included. 0..1 display Reviewing Pathologist 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#64320v3.0 MedDRA disease code 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2004425v4.0 Assessment Method 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#3914983v1.0
Value Set: ValueSet[null]Tumor grade 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2785839v2.0
Value Set: ValueSet[null]
Entry 4 - fullUrl = http://AHRQ.org/form/Questionnaire/F2674812v4.0
Resource Questionnaire:
LinkId Text Cardinality Type Description & Constraints Questionnaire http://hl7.org/fhir/uv/sdc/Questionnaire/2674812v4.0 Mandatory Demography Questions 1..1 group These items must be included when this data is collected for reporting 0..1 display Gender 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2200604v3.0
Value Set: ValueSet[null]Race 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2192199v1.0
Value Set: ValueSet[null]Patient's Date of Birth 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#793v5.1 Ethnicity 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2192217v2.0
Value Set: ValueSet[null]Conditional Demography Questions 0..1 group There are business rules to indicate situations under which these elements should be used on a case report form. 0..1 display ZIP Code 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2179606v2.0 Payment Method 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2865130v1.0
Value Set: ValueSet[null]Country of Residence 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#315v4.0 Date Completed 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2003745v5.0 CDC Race Code 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2200286v1.0 CDC Ethnicity Code 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2200284v2.0 Optional Demography Questions 0..1 group There is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included. 0..1 display Highest Education Level 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2681552v1.0
Value Set: ValueSet[null]Country of Birth 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2001708v5.0
Value Set: ValueSet[null]Highest Education Level 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2674076v2.0
Value Set: ValueSet[null]Census Tract Code at Enrollment 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2943243v1.0 Marital Status 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2188083v2.0
Value Set: ValueSet[null]
Entry 5 - fullUrl = http://AHRQ.org/form/Questionnaire/3265657v2.0
Resource Questionnaire:
LinkId Text Cardinality Type Description & Constraints A sample questionnaire example for sdc-questionnaire profile Questionnaire http://hl7.org/fhir/uv/sdc/Questionnaire/3265657v2.0 Mandatory Adverse Event Questions 1..1 group Must be included when this data is collected for reporting. 0..1 display Adverse Event Term (v4.0) 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#3125302v1.1
Value Set: ValueSet[null]Describe 'Other' Adverse Event 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2188132v1.0 Adverse Event Grade 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2944515v1.0
Value Set: ValueSet[null]Conditional Adverse Event Questions 0..1 group There are business rules to indicate situations under which this data element should be used in a CRF. 0..1 display AE Start Date 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2744993v1.0 Was patient hospitalized for toxicity? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2552398v1.0
Value Set: ValueSet[null]Cycle # 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2744948v1.0 Optional Adverse Event Questions 0..1 group No requirement for inclusion of this element on the CRF; if the design and scientific questions posed in the study dictate the need to collect this type of data, this is the element to include on the CRF. 0..1 display To what is the AE attributed? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2179892v2.0
Value Set: ValueSet[null]Other Attribution, Specify 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2201348v1.0 AE Stop Date 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2189843v1.0 MedDRA System Organ Class (SOC) 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2943864v1.0
Value Set: ValueSet[null]MedDRA AE Code (CTCAE v4.0) 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#3133353v1.0
Value Set: ValueSet[null]AE Attribution 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#1285v3.0
Value Set: ValueSet[null]Reporting Period End Date 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2006851v4.0 Were adverse events assessed during most recent period 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2179971v1.0
Value Set: ValueSet[null]Expected? (Yes/No) 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2183619v1.0
Value Set: ValueSet[null]Serious? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2199908v1.0
Value Set: ValueSet[null]Event Onset Time 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2585234v1.0 Course 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2732184v1.0 AE Evaluation Period Start Date 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2744943v1.0 Pre-existing AE? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2746280v1.0
Value Set: ValueSet[null]AE Resolved Time 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2746301v1.0 AE Ongoing? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2746311v1.0
Value Set: ValueSet[null]Participant Status/Outcome 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2746517v1.0
Value Set: ValueSet[null]Adverse Event Condition Pattern 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2008418v1.0
Value Set: ValueSet[null]Did event reappear after study agent was reintroduced? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2179615v1.0
Value Set: ValueSet[null]Comments 0..1 string Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#797v5.0 Optional Serious Adverse Event Questions 0..1 group The following additional elements are optional on a SAE form. 0..1 display Why serious? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2179679v3.0
Value Set: ValueSet[null]Dose-Limiting Toxicity? 0..1 open-choice Definition: http://example.org/nci.nih.gov/xml/owl/cadsr/data_element_scoped_identifier#2004106v3.0
Value Set: ValueSet[null]
IG © 2022+ HL7 International / FHIR Infrastructure. Package hl7.fhir.uv.sdc#3.0.0 based on FHIR 4.0.1. Generated 2023-12-07
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