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Safety Report Seriousness Source Label

Preserve explicitly reported seriousness wording and source without assigning a regulatory classification.

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Description

Preserve explicitly reported seriousness wording and source.

Medication-study records distinguish supplied coverage intervals, observed person-days, dispensing reversals and source event definitions. Inclusive calendar-day counting differs from continuous elapsed time. Recorded supply and washout flags are study conventions rather than evidence of ingestion, drug clearance, causal effect or suitable treatment.

Preserve explicitly reported seriousness wording and source.

When to use this tool

Use Safety Report Seriousness Source Label when you already have reportId, seriousnessWording, source and need to preserve explicitly reported seriousness wording and source.

How to use the tool and how it works

  1. Enter reportId, seriousnessWording, source. Use the units and conventions below.
  2. Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
  3. Read token. Use the output convention below.

Enter reportId, seriousnessWording, source using the field constraints below. Encode these values, in exactly that order, as a JSON array and return the serialized array as text in token. String values are preserved without trimming or external terminology lookup.1

Input fieldMeaning and unitsAccepted input
reportIdReport IdRequired. Text; minimum UTF-16 length 1; maximum UTF-16 length 8192.
seriousnessWordingSeriousness WordingRequired. Text; minimum UTF-16 length 1; maximum UTF-16 length 8192.
sourceSourceRequired. Text; minimum UTF-16 length 1; maximum UTF-16 length 8192.
Output fieldInterpretationReturned shape
tokenTokenRequired. Text; maximum UTF-16 length 8192.
json
{
  "input": {
    "reportId": "AE17",
    "seriousnessWording": "reported serious",
    "source": "Investigator record"
  },
  "output": {
    "token": "[\"AE17\",\"reported serious\",\"Investigator record\"]"
  }
}

Limitations and assumptions

  • The result records supplied values without assigning a regulatory classification. Sources and asserted relationships are not independently authenticated.
  • Inputs must satisfy both the field types and the cross-field conditions above. Invalid input causes an error; a successful false flag or documented placeholder is a different result.

Alternative or Complementary methods

Construct exposure episodes from a documented study rule and verified dispensing or observation history. Keep inclusive calendar coverage distinct from elapsed time and actual ingestion; evaluate causal questions with a complete study design rather than one interval flag.

References

  1. Calculation and input contract: pharmacoepidemiology/safety-report-seriousness-source-label — tool.io

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