A clear record of what the participant already had before the study is what makes adverse event reporting accurate. This template captures each condition with its onset, whether it is ongoing, and its severity at baseline.
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Condition or procedure
MHTERMBody system
MHBODSYSOnset date
MHSTDATYear-only onset accepted
Ongoing at screening?
MHONGOSeverity at baseline
What this template gives you
Why it matters
An adverse event is anything untoward that happens after consent (or first dose, depending on the protocol). A condition the participant already had is not an adverse event, unless it gets worse. That rule is simple on paper and hard in practice: without a clear record of what was present at baseline and how severe it was, sites either report pre-existing conditions as AEs (inflating safety tables) or miss real worsening.
The medical history form is that record. Completed at screening, it lists each relevant condition with its onset and whether it is ongoing, and captures severity at baseline. When the participant later reports a headache, the investigator can see that migraines were ongoing and moderate at baseline, and judge whether this episode represents a worsening worth recording on the adverse event form.
Most protocols ask for clinically significant conditions and surgeries, sometimes with a look-back period (for example the past five years) plus any lifetime history of specific conditions. Collecting every childhood illness adds burden without value. Write the rule into the CRF completion guidelines so every site collects the same scope.
Many studies add targeted questions for conditions that affect eligibility or safety: prior cancer, cardiovascular events, psychiatric history, substance use. These work best as specific yes or no questions with follow-up fields shown by skip logic, alongside the general log.
Participant reports a headache at Week 4
Check medical history
Migraine ongoing at baseline, moderate
Investigator judges: worse than baseline?
Severity or frequency increased
If worse: record on the AE log
Otherwise document as baseline condition
Field specification
| Field | Variable | Question type | Notes |
|---|---|---|---|
| Condition or procedure | MHTERM | Text | Verbatim; coded to MedDRA later. |
| Body system | MHBODSYS | Dropdown | Helps review and coding; optional. |
| Onset date | MHSTDAT | Date | Partial dates accepted. |
| Ongoing at screening? | MHONGO | Single choice | Yes shows baseline severity. |
| End date | MHENDAT | Date | When not ongoing. |
| Severity at baseline | Sponsor-defined | Single choice | Mild, moderate, severe; reference for later AEs. |
| Currently treated? | Sponsor-defined | Single choice | Yes prompts a con med entry. |
CDASH-style names with the SDTM MH domain label. Not a validated SDTM transformation.
At screening
Medical history belongs on the screening visit, alongside demographics, eligibility and vital signs. Because the schedule places it there, the status overview shows immediately which screened participants are missing it, before they are enrolled.
Start screening
Screen new subject
Not screened before
Rescreen subject
Needs a new screening number
ICF date
14-Sep-2026
Year of birth
1971
Sex
Female
Demographics, medical history, vital signs and eligibility, ready in the free sandbox.
Coding and review
Medical history terms are entered as the site writes them and coded to MedDRA later by data management, keeping the verbatim term alongside the code. Coding matters for more than tables: a medical monitor reviewing eligibility needs to see at a glance whether any participant has a condition the protocol excludes, and coded terms make that search reliable.
Most protocols also add targeted history questions for conditions that matter to the study. These are best asked as specific yes or no questions with follow-up fields shown only when the answer is yes, rather than relying on sites to remember to list them in the general log.
Cardiovascular safety studies ask about prior myocardial infarction, heart failure and arrhythmia. CNS studies ask about seizures, psychiatric history and substance use. Oncology studies ask about prior malignancies and treatments. Dermatology studies ask about prior systemic therapies. Each becomes a short structured section, and each answer can support an eligibility check.
Before you approve
Look-back period and conditions of interest written into completion guidelines.
Specific yes or no questions for eligibility-relevant conditions.
For ongoing conditions, so later worsening can be judged.
MedDRA version and conventions named in the data management plan.
Treated conditions matched to concomitant medications.
Placed on the screening visit before enrolment.
Relevant past and current conditions and procedures, with onset date, whether each is ongoing, and often severity at baseline.
No, unless it worsens after the AE reporting period begins. The medical history record is what lets the investigator make that judgement.
The protocol defines it, often clinically significant conditions within a set period plus lifetime history of specific conditions.
Usually to MedDRA, by data management after entry, keeping the verbatim term.
Yes, in the Capture template library in the free sandbox.
Keep exploring
Adverse event eCRF template
Where worsening is recorded.
Concomitant medications template
Treatments for these conditions.
Demographics eCRF template
Also completed at screening.
Physical exam eCRF template
Baseline examination findings.
Adverse event reporting
The safety workflow.
Reference interval
Baseline lab values.
Copy the medical history template and adapt it. Free sandbox.