Description
Check protocolDay ≤ amendmentDay ≤ approvalDay and compare approval with affectedEventDay.
Laboratory study records distinguish observations, sample identities, personnel, and supporting sources. Missingness and duplication depend on record scope; a metadata check cannot establish scientific validity or regulatory acceptance.
Check protocolDay ≤ amendmentDay ≤ approvalDay and compare approval with affectedEventDay.
When to use this tool
Use GLP Protocol Amendment Chronology Pair when you need a laboratory-record consistency or source-support check.
How to use the tool and how it works
- Enter protocolDay, amendmentDay, approvalDay, affectedEventDay, retroactiveAllowed. Use the units and conventions below.
- Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
- Read chronology, approvedBeforeEvent, retroactive, acceptableUnderFlag. Inspect chronology, approvedBeforeEvent, retroactive, acceptableUnderFlag before interpreting the associated values.
Check protocolDay ≤ amendmentDay ≤ approvalDay and compare approval with affectedEventDay. Return chronology, approvedBeforeEvent, retroactive, and acceptableUnderFlag when chronology holds and approval preceded the event or retroactiveAllowed.1
| Input field | Meaning and units | Accepted input |
|---|---|---|
| protocolDay | Protocol Day | Required. Safe integer. |
| amendmentDay | Amendment Day | Required. Safe integer. |
| approvalDay | Approval Day | Required. Safe integer. |
| affectedEventDay | Affected Event Day | Required. Safe integer. |
| retroactiveAllowed | Retroactive Allowed | Required. Boolean. |
| Output field | Interpretation | Returned shape |
|---|---|---|
| chronology | Chronology | Required. Boolean. |
| approvedBeforeEvent | Approved Before Event | Required. Boolean. |
| retroactive | Retroactive | Required. Boolean. |
| acceptableUnderFlag | Acceptable Under Flag | Required. Boolean. |
{
"input": {
"protocolDay": 100,
"amendmentDay": 110,
"approvalDay": 112,
"affectedEventDay": 120,
"retroactiveAllowed": false
},
"output": {
"chronology": true,
"approvedBeforeEvent": true,
"retroactive": false,
"acceptableUnderFlag": true
}
}Limitations and assumptions
- The flag is caller policy rather than legal authorization; actual amendments, approval evidence, study impact, and GLP compliance are not evaluated.
- 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
Review the controlled study records and audit trail for the complete evidentiary chain. Resolve duplicate identifiers, sampling units, and authorization rules before drawing study-level conclusions.
References
Similar or alternative tools
- GMP Deviation Approved Scope Dategap
Test process membership and eventDay inside the inclusive approval window, then combine those flags with approved for eligible.
- GLP Rawdata Correction Original Link
Compare originalId with correctionParent and originalValue with correctedValue.