Trial Arm Source Gap Tool

Description

Compare assigned trial arms with source labels.

Clinical research distinguishes supplied protocol metadata, participant/event records, allocation bookkeeping and an analysis target. A local count, permission flag or denominator choice can help reconcile records without establishing valid consent, randomization, regulatory compliance or a reliable treatment-effect estimate.

Compare assigned trial arms with source labels.

When to use this tool

Use Trial Arm Source Gap when checking the stated clinical-research record, allocation, timing, analysis or evidence-basis convention.

How to use the tool and how it works

Enter participantIds, assignedArms, sourceArms, validArms. Keep parallel arrays aligned. Use the units and conventions below.
Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
Read armMismatches, unknownAssignedArms, supportedAssignments. Use the output convention below.

Compare assigned trial arms with source labels. Require aligned participant IDs/assigned/source arms; count literal mismatches, assigned labels absent from validArms and matching valid assignments.^[1]

Input field	Meaning and units	Accepted input
participantIds	Participant Ids	Required. Array of text; maximum UTF-16 length 8192; maximum items 256.
assignedArms	Assigned Arms	Required. Array of text; maximum UTF-16 length 8192; maximum items 256.
sourceArms	Source Arms	Required. Array of text; maximum UTF-16 length 8192; maximum items 256.
validArms	Valid Arms	Required. Array of text; maximum UTF-16 length 8192; maximum items 256.

Output field	Interpretation	Returned shape
armMismatches	Arm Mismatches	Required. Safe integer.
unknownAssignedArms	Unknown Assigned Arms	Required. Safe integer.
supportedAssignments	Supported Assignments	Required. Safe integer.

json

{
  "input": {
    "participantIds": [
      "p1",
      "p2"
    ],
    "assignedArms": [
      "A",
      "B"
    ],
    "sourceArms": [
      "A",
      "A"
    ],
    "validArms": [
      "A",
      "B"
    ]
  },
  "output": {
    "armMismatches": 1,
    "unknownAssignedArms": 0,
    "supportedAssignments": 1
  }
}

Limitations and assumptions

Records are counted per row without deduplication; no allocation source, randomization or participant identity is 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

Use the complete approved protocol, authenticated source records and qualified clinical/statistical oversight for actual trial design, conduct and interpretation.

References

Calculation and input contract: clinical-trials/trial-arm-source-gap — tool.io

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