Description
Compare consent versions and signature timing.
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 consent versions and signature timing.
When to use this tool
Use Trial Consent Reconsent Version 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 oldVersion, newVersion, signedVersion, changeDay, signedDay, visitDay. Use the units and conventions below.
- Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
- Read versionChanged, signedCurrent, gapDays, currentBeforeVisit. Inspect versionChanged, signedCurrent, currentBeforeVisit before interpreting the associated values.
Compare consent versions and signature timing. versionChanged compares old/new, signedCurrent compares signed/new, gapDays = signedDay-changeDay; currentBeforeVisit requires current version and changeDay <= signedDay <= visitDay.1
| Input field | Meaning and units | Accepted input |
|---|---|---|
| oldVersion | Old Version | Required. Text; maximum UTF-16 length 8192. |
| newVersion | New Version | Required. Text; maximum UTF-16 length 8192. |
| signedVersion | Signed Version | Required. Text; maximum UTF-16 length 8192. |
| changeDay | Change Day | Required. Safe integer. |
| signedDay | Signed Day | Required. Safe integer. |
| visitDay | Visit Day | Required. Safe integer. |
| Output field | Interpretation | Returned shape |
|---|---|---|
| versionChanged | Version Changed | Required. Boolean. |
| signedCurrent | Signed Current | Required. Boolean. |
| gapDays | Gap Days | Required. Safe integer. |
| currentBeforeVisit | Current Before Visit | Required. Boolean. |
{
"input": {
"oldVersion": "v1",
"newVersion": "v2",
"signedVersion": "v2",
"changeDay": 100,
"signedDay": 103,
"visitDay": 110
},
"output": {
"versionChanged": true,
"signedCurrent": true,
"gapDays": 3,
"currentBeforeVisit": true
}
}Limitations and assumptions
- Labels and dates do not verify informed consent, capacity, required reconsent, identity or a legally valid signature.
- 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.
- Numeric calculations use binary floating point unless exact decimal-integer arithmetic is explicitly stated. No hidden measurement tolerance or decimal rounding is added; nonfinite or out-of-contract results are rejected. Numeric signed-zero results are exported as zero.
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
Similar or alternative tools
- Consent Purpose Support Count
Count distinct requested purposes present or absent in a supplied consent-support list.
- Trial Result Prespecified Estimand Label Tool
Audit supplied estimand labels and metadata without deriving an estimand.