Page Last Updated: April 18, 2026

Clinical Data Validation Procedure🔗

Validation procedures for Electronic Health Records (EHR) data are performed as follows:

  1. Load EHR data from the site into the Landing Zone within the Secure Computing Environment
  2. Run a script to validate that the Landing Zone data was loaded correctly that checks for the following issues and coordinate with the site to correct these issues:
    • Dates only sent when expecting date / time
    • Time only sent when expecting date / time
    • Date / time format was unknown to import script so it was imported as a varchar (requires changes to import script)
    • Headers not sent so the column names are based on the first row of the data
    • Rows are all NULL values because the file had rows with no data
  3. Run the Landing Zone to OMOP mapping scripts for each site
    • Correct any known site-specific issues that can be automatically corrected in the scripts
    • Let the site know of any issues with their data preventing mapping of their data
    • Move data that passes QA into the central HBCD Clinical Data Repository (versioned for each year)
  4. Generate two reports back to each site
    [1] EHR data received by participant study ID
    [2] Summary Table 1 for the site
Example Table 1 Summary (Birth Parent) â–¸
Characteristic Total
N 870
Demographics  
Mean age (± SD) 31.69 (5.69)
Sex|FEMALE 870 (100.0)
Sex|MALE 0 (0.0)
Sex|No matching concept 0 (0.0)
Race|American Indian or Alaska Native 10 (1.1)
Race|Asian 39 (4.5)
Race|Black or African American 197 (22.6)
Race|Native Hawaiian or Other Pacific Islander < 10
Race|No matching concept 105 (12.1)
Race|White 517 (59.4)
Ethnicity|Hispanic or Latino 122 (14.0)
Ethnicity|Not Hispanic or Latino 748 (86.0)
Ethnicity|No Matching Concept 0 (0.0)
Conditions  
Major depression, single episode < 10
Second trimester pregnancy 127 (14.6)
Third trimester pregnancy 117 (13.4)
First trimester pregnancy 88 (10.1)
Disorder of pregnancy 87 (10.0)
Complication occurring during pregnancy 66 (7.6)
Anxiety disorder 66 (7.6)
Depressive disorder 64 (7.4)
Fetal condition affecting obstetrical care of mother 52 (6.0)
Gestation period, 36 weeks 50 (5.7)
Anemia of pregnancy 47 (5.4)
Mental disorders during pregnancy, childbirth and the puerperium 46 (5.3)
Finding related to pregnancy 34 (3.9)
Uncomplicated asthma 28 (3.2)
Disease of the respiratory system complicating pregnancy, childbirth and/or the puerperium 28 (3.2)
Poor fetal growth affecting management 27 (3.1)
Maternal obesity complicating pregnancy, childbirth and the puerperium, antepartum 24 (2.8)
Generalized anxiety disorder 18 (2.1)
Posttraumatic stress disorder 14 (1.6)
High risk pregnancy 11 (1.3)
Lab Results  
Body temperature (degree Celsius) 36.69 (0.18)
Systolic blood pressure (millimeter mercury column) 119.48 (9.42)
Diastolic blood pressure (millimeter mercury column) 72.49 (5.62)
Heart rate (counts per minute) 91.58 (8.91)
No matching concept (nanogram per milliliter) 358.33 (1243.37)
Pain severity - 0-10 verbal numeric rating [Score] - Reported 1.77 (1.01)
Hematocrit [Volume Fraction] of Blood by Automated count (percent) 34.81 (3.19)
MCV [Entitic volume] by Automated count (femtoliter) 88.14 (6.84)
MCH [Entitic mass] by Automated count (picogram) 29.53 (2.52)
Erythrocyte distribution width [Ratio] by Automated count (percent) 13.65 (1.58)
Respiratory rate (counts per minute) 17.35 (0.54)
Platelet mean volume [Entitic volume] in Blood by Automated count (femtoliter) 10.52 (1.09)
Body temperature (degree Fahrenheit) 97.87 (0.26)
Erythrocyte distribution width [Entitic volume] by Automated count (femtoliter) 43.61 (8.49)
No matching concept (milligram per deciliter) 98.85 (122.08)
Hemoglobin [Mass/volume] in Blood (gram per deciliter) 11.64 (1.14)
Oxygen saturation in Arterial blood by Pulse oximetry (percent) 97.99 (1.05)
Body weight (kilogram) 83.74 (25.21)
Body height (centimeter) 163.48 (6.62)
Procedures  
Ultrasound scan for fetal growth < 10
Antenatal screening 12 (1.4)
Monitoring of Products of Conception, Cardiac Rate, External Approach 10 (1.1)
Fetal biophysical profile < 10
Ultrasonography for antepartum monitoring of fetus < 10
Ultrasound scan - obstetric < 10
Ultrasound scan for fetal nuchal translucency < 10
Ultrasonography in first trimester < 10
Delivery of Products of Conception, External Approach < 10
Ultrasonography of Third Trimester, Single Fetus < 10
X-ray of chest anteroposterior view < 10
Extraction of Products of Conception, Low, Open Approach < 10
Drainage of Amniotic Fluid, Therapeutic from Products of Conception, Via Natural or Artificial Opening < 10
Ultrasonography of Second Trimester, Single Fetus < 10
Diagnostic radiography of chest, combined PA and lateral < 10
Counseling < 10
Ultrasonography of cervix uteri < 10
Insertion of Other Device into Products of Conception, Via Natural or Artificial Opening < 10
Repair Perineum Muscle, Open Approach < 10
Medications  
sodium chloride 142 (16.3)
ibuprofen 132 (15.2)
potassium chloride 125 (14.4)
calcium chloride 124 (14.3)
lactate 124 (14.3)
acetaminophen 85 (9.8)
ondansetron 79 (9.1)
sennosides, USP 63 (7.2)
oxycodone 62 (7.1)
folic acid 60 (6.9)
docusate 57 (6.6)
ketorolac 54 (6.2)
glucose 53 (6.1)
oxytocin 47 (5.4)
famotidine 45 (5.2)
simethicone 43 (4.9)
gabapentin 25 (2.9)
buprenorphine 11 (1.3)