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A medical history form (also called a patient medical history questionnaire or baseline medical history case report form [CRF]) is a structured clinical intake instrument used by ambulatory clinics, hospitals, and clinical research sites to document a patient’s pre-existing health conditions, prior surgical interventions, current medications, allergies, biological family medical history, and social history before physical examination or protocol intervention.
In modern health informatics, paper and electronic medical history templates are designed so that every section maps directly to standardized HL7 C-CDA R2.1 document sections, LOINC section codes, HL7 FHIR R4 resources, or the CDISC CDASH/SDTM Medical History (MH) domain.
What Is a Medical History Form and When Is It Used?
A medical history form serves two distinct operational functions depending on whether it is deployed in routine clinical delivery or in a regulated clinical trial:
- Ambulatory & Inpatient Clinical Care: Completed by the patient prior to an initial evaluation and verified by a clinician during intake alongside medication reconciliation and a Review of Systems (ROS) template. It establishes baseline diagnostic risk, contraindicates unsafe prescriptions, and populates structured problem, allergy, and family history lists in the EHR.
- Clinical Trial Screening & Baseline Documentation: Completed by the investigator or clinical research coordinator during the screening visit to verify protocol inclusion/exclusion criteria and to establish which conditions existed prior to informed consent or first dose of investigational product. Any condition present at baseline is recorded on the Medical History (`MH`) form, whereas any new condition or clinically significant worsening after baseline is recorded as an Adverse Event (`AE`).
Copy-Ready Clinical & Family Medical History Form Template
The structured template below incorporates standard outpatient clinical intake fields, first- and second-degree family medical history form fields, and CDISC CDASH start/ongoing status indicators. Replace bracketed placeholders ([...]) with institutional header metadata:
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[INSTITUTION / CLINIC / STUDY SITE NAME] — PATIENT & FAMILY MEDICAL HISTORY FORM
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Patient / Subject ID: [________] Date of Birth: [YYYY-MM-DD] Sex: [______]
Encounter / Screening Date: [YYYY-MM-DD] Completed By: [ ] Patient [ ] Staff
SECTION 1: PAST MEDICAL HISTORY (LOINC 11348-0 | CDISC Domain: MH)
Check all conditions ever diagnosed by a healthcare professional and record year:
[ ] None / No known significant past medical history
Body System / Condition Description Diagnosis Year / Onset Currently Active?
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Cardiovascular (e.g., HTN, CAD, AFib, CHF): [____________________] [ ] Yes [ ] No
Endocrine / Metabolic (e.g., Type 1/2 DM): [____________________] [ ] Yes [ ] No
Respiratory (e.g., Asthma, COPD, OSA): [____________________] [ ] Yes [ ] No
Neurological (e.g., Stroke/TIA, Seizures): [____________________] [ ] Yes [ ] No
Gastrointestinal / Hepatic: [____________________] [ ] Yes [ ] No
Renal / Genitourinary (e.g., CKD): [____________________] [ ] Yes [ ] No
Oncologic / Hematologic (Specify site): [____________________] [ ] Yes [ ] No
Autoimmune / Rheumatologic: [____________________] [ ] Yes [ ] No
Psychiatric / Behavioral Health: [____________________] [ ] Yes [ ] No
Other Significant Medical Conditions: [____________________] [ ] Yes [ ] No
SECTION 2: PAST SURGICAL & HOSPITALIZATION HISTORY (LOINC 47519-4)
[ ] No prior surgeries or hospitalizations
1. Procedure / Reason: [___________________________] Year: [____] Facility: [______]
2. Procedure / Reason: [___________________________] Year: [____] Facility: [______]
3. Procedure / Reason: [___________________________] Year: [____] Facility: [______]
SECTION 3: CURRENT MEDICATIONS & ALLERGIES (LOINC 10160-0 & 48765-2)
Allergies: [ ] NKDA (No Known Drug Allergies)
- Allergen (Drug/Food/Latex): [________________] Reaction / Severity: [___________]
Current Medications (Prescription, OTC, Supplements):
1. Medication Name: [______________] Dose: [_____] Frequency: [____] Route: [___]
2. Medication Name: [______________] Dose: [_____] Frequency: [____] Route: [___]
SECTION 4: FAMILY MEDICAL HISTORY FORM (LOINC 10157-6 | FHIR FamilyMemberHistory)
[ ] Adopted / Biological family history unknown
[ ] No known family history of hereditary, cardiovascular, metabolic, or oncologic disease
Biological Relative Living? Medical Condition(s) Age at Diagnosis
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Mother [ ]Y [ ]N [_____________________________] [______________]
Father [ ]Y [ ]N [_____________________________] [______________]
Sibling(s) (M / F) [ ]Y [ ]N [_____________________________] [______________]
Children (Son / Dtr) [ ]Y [ ]N [_____________________________] [______________]
Maternal Grandparents [ ]Y [ ]N [_____________________________] [______________]
Paternal Grandparents [ ]Y [ ]N [_____________________________] [______________]
SECTION 5: SOCIAL & PREVENTIVE HISTORY (LOINC 29762-2)
Tobacco / Nicotine Status: [ ] Never [ ] Former (Quit year: ____) [ ] Current
Alcohol Consumption: [ ] None [ ] Occasional [ ] Regular (Drinks/wk: ____)
Occupation / Environmental Exposures: [_____________________________________________]
Clinician / Coordinator Review Signature: _______________________ Date: [YYYY-MM-DD]
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Required Sections Mapped to LOINC, HL7 FHIR R4, and CDISC Standards
To ensure that digital medical history questionnaires built in REDCap, electronic data capture (EDC) systems, or EHR patient portals interoperate across clinical repositories, each form section maps to explicit federal and international standards:
| Form Section | LOINC Section Code | HL7 FHIR R4 Resource & Coding Vocabulary | CDISC CDASH / SDTM Domain & Key Variables |
|---|---|---|---|
| History of Present Illness (HPI) | 10164-2 (History of Present illness Narrative) |
Condition (category = encounter-diagnosis) & Composition.section |
Captured in disease-specific baseline assessment domains or MH with MHCAT. |
| Past Medical History (PMH) | 11348-0 (History of Past illness note) |
Condition (clinicalStatus = active | resolved); coded in SNOMED CT and ICD-10-CM |
MH (Medical History): MHTERM (verbatim), MHDECOD (MedDRA Preferred Term), MHBODSYS (SOC), MHSTDTC, MHENRF/MHONGO. |
| Past Surgical History (PSH) | 47519-4 (History of Procedures Document) |
Procedure (status = completed, performedDateTime); coded in SNOMED CT or CPT |
PR (Procedures) or MH (with MHCAT = SURGICAL HISTORY). |
| Medication History | 10160-0 (History of Medication use Narrative) |
MedicationStatement / MedicationRequest; coded in RxNorm |
CM (Concomitant / Prior Medications): CMTRT, CMDOSE, CMROUTE, CMSTDTC, CMONGO (coded to WHODrug). |
| Allergies & Intolerances | 48765-2 (Allergies and adverse reactions Document) |
AllergyIntolerance (criticality, reaction.manifestation); coded in RxNorm / SNOMED CT |
Recorded in MH (MHCAT = ALLERGY HISTORY) or dedicated hypersensitivity CRFs. |
| Family Medical History | 10157-6 (History of family member diseases Narrative) |
FamilyMemberHistory (relationship via HL7 v3 RoleCode, condition.code in SNOMED CT, condition.onsetAge) |
MH or Subject Characteristics (SC) / Family History supplemental qualifiers depending on genetic protocol scope. |
| Social History | 29762-2 (Social history Narrative) |
Observation (category = social-history, LOINC smoking/alcohol/SDOH codes) |
SU (Substance Use): SUTRT, SUCAT (Tobacco, Alcohol, Caffeine), SUDOSE, SUSTDTC. |
Common Mistakes in Clinical and Research Medical History Forms
- Omitting Ongoing Status (`MHONGO` / `MHENRF`) in Clinical Trials: In regulated trials, failing to document whether a pre-existing condition is resolved (`End Date` known) or still active (`Ongoing = Yes`) at baseline makes it impossible for safety monitors to distinguish a pre-existing chronic symptom from a treatment-emergent Adverse Event (`TEAE`).
- Conflating Maternal and Paternal Lineages on Family History Forms: Generic checkboxes that ask whether a “grandparent, aunt, or uncle” had breast, ovarian, or colorectal cancer without specifying maternal vs. paternal side cannot be used to compute validated hereditary cancer risk scores (such as Tyrer-Cuzick or Gail models) or populate the HL7 FHIR `FamilyMemberHistory.relationship` value set (`MGRMTH`, `PGRMTH`, etc.).
- Leaving Sections Blank Instead of Recording Explicit Negatives: Under Good Clinical Practice (ICH E6) and ALCOA+ data integrity rules, an empty table row is ambiguous (it could mean “not asked”). Every medical history section should include an explicit negative checkbox (e.g.,
[ ] None / No known past medical history, coded to `MHPRESP = Y` and `MHOCCUR = N` in CDISC CDASH).
Frequently Asked Questions
What is a medical history form?
A medical history form (or medical history questionnaire) is a structured clinical data collection instrument used at patient intake or clinical trial screening to record a person’s past medical diagnoses (PMH), prior surgeries and hospitalizations (PSH), current medications, allergies, biological family medical history, social determinants of health, and baseline review of systems.
How is a medical history form standardized in EHRs and clinical trials?
In electronic health records (EHRs), medical history form sections are tagged using Logical Observation Identifiers Names and Codes (LOINC)—such as 11348-0 for Past Medical History, 47519-4 for Surgical History, and 10157-6 for Family History—and exchanged via HL7 C-CDA R2.1 or HL7 FHIR Questionnaire and FamilyMemberHistory resources. In regulated clinical trials, medical history case report forms follow the CDISC Clinical Data Acquisition Standards Harmonization (CDASH) Medical History (MH) domain.







