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Claude Skills by Manoj-11-Dahal
github.com/Manoj-11-Dahal15,860 skills0 installs0 views
- Trial Ops Deviation Log Exception Triage QueueUse when the protocol-deviation documentation workflow has exceptions, missing evidence, or competing priorities to produce a prioritized exception queue for the protocol deviation evidence log with evidence, owner, and next action. Success means every exception has a severity rationale, source, owner or explicit unassigned state, and a bounded next step; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use configured search, fetch...Votes: 0GitHub stars: 2
- Trial Ops Deviation Log Recovery Readiness DrillUse when the protocol-deviation documentation workflow needs a safe recovery, rollback, replay, or continuity check to produce a recovery-drill record for the protocol deviation evidence log with starting state, test, and observed outcome. Success means the dry-run or approved non-production drill meets the predeclared recovery target and leaves the baseline intact; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use configured se...Votes: 0GitHub stars: 2
- Trial Ops Deviation Log Scenario Sensitivity MatrixUse when the protocol-deviation documentation team needs to compare options under changing assumptions to produce a baseline-plus-scenarios matrix for the protocol deviation evidence log with assumptions and ranges. Success means the baseline is reproducible, scenario inputs are explicit, comparable units are used, and conclusions state uncertainty; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use configured search, fetch, read...Votes: 0GitHub stars: 2
- Trial Ops Deviation Log Scope Intake GateUse when a new protocol-deviation documentation request needs a bounded work scope to produce a scoped intake card for the protocol deviation evidence log. Success means owner, objective, permitted sources, acceptance condition, exclusions, and deadline are explicit; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. Record ev...Votes: 0GitHub stars: 2
- Trial Ops Deviation Log Source Provenance LedgerUse when a decision about protocol-deviation documentation depends on facts from several records or public sources to produce a source-to-claim provenance ledger for the protocol deviation evidence log. Success means each material claim has a source, version/date, location, and confidence note; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use configured search, fetch, read, browser, test, and write capabilities only when releva...Votes: 0GitHub stars: 2
- Trial Ops Deviation Log Threshold Rule CheckUse when a protocol-deviation documentation decision depends on a limit, eligibility rule, policy, or target to produce a rule-check record for the protocol deviation evidence log showing source, units, boundary case, and outcome. Success means the rule source and effective date are verified, units and scope match, and borderline cases are flagged rather than auto-approved; events are described without assigning seriousness or causality unless the qualified investigator recorded it. Use confi...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Approval Evidence PacketUse when a electronic data-capture change control result is ready for a human owner to approve, reject, or redirect to produce a decision packet for the EDC change-impact checklist containing options, evidence, risks, and open questions. Success means the decision owner, requested decision, source evidence, alternatives, uncertainty, and consequence of no action are all visible; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fe...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Closeout Handoff LedgerUse when a electronic data-capture change control work item is nearing completion, pause, or transfer to another owner to produce a closeout ledger for the EDC change-impact checklist with status, evidence, owner, and retention state. Success means all deliverables, unresolved items, approvals, and next owners are recorded, and the stop reason is explicit; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, tes...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Completeness ReconciliationUse when the electronic data-capture change control workflow receives records that must agree across sources, periods, or statuses to produce a reconciliation worksheet for the EDC change-impact checklist with matched, unmatched, and unresolved rows. Success means counts and key fields reconcile or every variance is quantified, sourced, and left unresolved for an owner; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Exception Triage QueueUse when the electronic data-capture change control workflow has exceptions, missing evidence, or competing priorities to produce a prioritized exception queue for the EDC change-impact checklist with evidence, owner, and next action. Success means every exception has a severity rationale, source, owner or explicit unassigned state, and a bounded next step; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, te...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Impact TraceUse when a version, rule, source, or stakeholder change may affect electronic data-capture change control to produce a before/after change record and impact map for the EDC change-impact checklist. Success means each material difference is tied to affected dependencies, consumers, owners, and a test or explicitly unknown impact; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, test, and write capabilities on...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Recovery Readiness DrillUse when the electronic data-capture change control workflow needs a safe recovery, rollback, replay, or continuity check to produce a recovery-drill record for the EDC change-impact checklist with starting state, test, and observed outcome. Success means the dry-run or approved non-production drill meets the predeclared recovery target and leaves the baseline intact; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, ...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Scenario Sensitivity MatrixUse when the electronic data-capture change control team needs to compare options under changing assumptions to produce a baseline-plus-scenarios matrix for the EDC change-impact checklist with assumptions and ranges. Success means the baseline is reproducible, scenario inputs are explicit, comparable units are used, and conclusions state uncertainty; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, test, an...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Scope Intake GateUse when a new electronic data-capture change control request needs a bounded work scope to produce a scoped intake card for the EDC change-impact checklist. Success means owner, objective, permitted sources, acceptance condition, exclusions, and deadline are explicit; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. Record evidence, limit refin...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Source Provenance LedgerUse when a decision about electronic data-capture change control depends on facts from several records or public sources to produce a source-to-claim provenance ledger for the EDC change-impact checklist. Success means each material claim has a source, version/date, location, and confidence note; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. ...Votes: 0GitHub stars: 2
- Trial Ops Edc Change Threshold Rule CheckUse when a electronic data-capture change control decision depends on a limit, eligibility rule, policy, or target to produce a rule-check record for the EDC change-impact checklist showing source, units, boundary case, and outcome. Success means the rule source and effective date are verified, units and scope match, and borderline cases are flagged rather than auto-approved; each change has a controlled version and test evidence before a system owner releases it. Use configured search, fetch...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Approval Evidence PacketUse when a research ethics submission administration result is ready for a human owner to approve, reject, or redirect to produce a decision packet for the ethics submission completeness map containing options, evidence, risks, and open questions. Success means the decision owner, requested decision, source evidence, alternatives, uncertainty, and consequence of no action are all visible; every package item maps to a controlled version and ethics approval is never inferred from submission sta...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Change Impact TraceUse when a version, rule, source, or stakeholder change may affect research ethics submission administration to produce a before/after change record and impact map for the ethics submission completeness map. Success means each material difference is tied to affected dependencies, consumers, owners, and a test or explicitly unknown impact; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured search, fetch, read, browser, t...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Closeout Handoff LedgerUse when a research ethics submission administration work item is nearing completion, pause, or transfer to another owner to produce a closeout ledger for the ethics submission completeness map with status, evidence, owner, and retention state. Success means all deliverables, unresolved items, approvals, and next owners are recorded, and the stop reason is explicit; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured sea...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Completeness ReconciliationUse when the research ethics submission administration workflow receives records that must agree across sources, periods, or statuses to produce a reconciliation worksheet for the ethics submission completeness map with matched, unmatched, and unresolved rows. Success means counts and key fields reconcile or every variance is quantified, sourced, and left unresolved for an owner; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use ...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Exception Triage QueueUse when the research ethics submission administration workflow has exceptions, missing evidence, or competing priorities to produce a prioritized exception queue for the ethics submission completeness map with evidence, owner, and next action. Success means every exception has a severity rationale, source, owner or explicit unassigned state, and a bounded next step; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured se...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Recovery Readiness DrillUse when the research ethics submission administration workflow needs a safe recovery, rollback, replay, or continuity check to produce a recovery-drill record for the ethics submission completeness map with starting state, test, and observed outcome. Success means the dry-run or approved non-production drill meets the predeclared recovery target and leaves the baseline intact; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use co...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Scenario Sensitivity MatrixUse when the research ethics submission administration team needs to compare options under changing assumptions to produce a baseline-plus-scenarios matrix for the ethics submission completeness map with assumptions and ranges. Success means the baseline is reproducible, scenario inputs are explicit, comparable units are used, and conclusions state uncertainty; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured search, ...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Scope Intake GateUse when a new research ethics submission administration request needs a bounded work scope to produce a scoped intake card for the ethics submission completeness map. Success means owner, objective, permitted sources, acceptance condition, exclusions, and deadline are explicit; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Source Provenance LedgerUse when a decision about research ethics submission administration depends on facts from several records or public sources to produce a source-to-claim provenance ledger for the ethics submission completeness map. Success means each material claim has a source, version/date, location, and confidence note; every package item maps to a controlled version and ethics approval is never inferred from submission status. Use configured search, fetch, read, browser, test, and write capabilities only ...Votes: 0GitHub stars: 2
- Trial Ops Ethics Submission Threshold Rule CheckUse when a research ethics submission administration decision depends on a limit, eligibility rule, policy, or target to produce a rule-check record for the ethics submission completeness map showing source, units, boundary case, and outcome. Success means the rule source and effective date are verified, units and scope match, and borderline cases are flagged rather than auto-approved; every package item maps to a controlled version and ethics approval is never inferred from submission status...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Approval Evidence PacketUse when a research monitoring and inspection readiness result is ready for a human owner to approve, reject, or redirect to produce a decision packet for the monitoring evidence index containing options, evidence, risks, and open questions. Success means the decision owner, requested decision, source evidence, alternatives, uncertainty, and consequence of no action are all visible; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Change Impact TraceUse when a version, rule, source, or stakeholder change may affect research monitoring and inspection readiness to produce a before/after change record and impact map for the monitoring evidence index. Success means each material difference is tied to affected dependencies, consumers, owners, and a test or explicitly unknown impact; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fetch, read, browser, test, and...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Closeout Handoff LedgerUse when a research monitoring and inspection readiness work item is nearing completion, pause, or transfer to another owner to produce a closeout ledger for the monitoring evidence index with status, evidence, owner, and retention state. Success means all deliverables, unresolved items, approvals, and next owners are recorded, and the stop reason is explicit; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fet...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Completeness ReconciliationUse when the research monitoring and inspection readiness workflow receives records that must agree across sources, periods, or statuses to produce a reconciliation worksheet for the monitoring evidence index with matched, unmatched, and unresolved rows. Success means counts and key fields reconcile or every variance is quantified, sourced, and left unresolved for an owner; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configur...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Exception Triage QueueUse when the research monitoring and inspection readiness workflow has exceptions, missing evidence, or competing priorities to produce a prioritized exception queue for the monitoring evidence index with evidence, owner, and next action. Success means every exception has a severity rationale, source, owner or explicit unassigned state, and a bounded next step; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fe...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Recovery Readiness DrillUse when the research monitoring and inspection readiness workflow needs a safe recovery, rollback, replay, or continuity check to produce a recovery-drill record for the monitoring evidence index with starting state, test, and observed outcome. Success means the dry-run or approved non-production drill meets the predeclared recovery target and leaves the baseline intact; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Scenario Sensitivity MatrixUse when the research monitoring and inspection readiness team needs to compare options under changing assumptions to produce a baseline-plus-scenarios matrix for the monitoring evidence index with assumptions and ranges. Success means the baseline is reproducible, scenario inputs are explicit, comparable units are used, and conclusions state uncertainty; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fetch, r...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Scope Intake GateUse when a new research monitoring and inspection readiness request needs a bounded work scope to produce a scoped intake card for the monitoring evidence index. Success means owner, objective, permitted sources, acceptance condition, exclusions, and deadline are explicit; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. Record...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Source Provenance LedgerUse when a decision about research monitoring and inspection readiness depends on facts from several records or public sources to produce a source-to-claim provenance ledger for the monitoring evidence index. Success means each material claim has a source, version/date, location, and confidence note; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use configured search, fetch, read, browser, test, and write capabilities only when rel...Votes: 0GitHub stars: 2
- Trial Ops Monitoring Threshold Rule CheckUse when a research monitoring and inspection readiness decision depends on a limit, eligibility rule, policy, or target to produce a rule-check record for the monitoring evidence index showing source, units, boundary case, and outcome. Success means the rule source and effective date are verified, units and scope match, and borderline cases are flagged rather than auto-approved; every finding links to the controlled evidence and participant identifiers are minimized in shared outputs. Use co...Votes: 0GitHub stars: 2
- Trial Ops Query Management Approval Evidence PacketUse when a research data-query administration result is ready for a human owner to approve, reject, or redirect to produce a decision packet for the data query aging report containing options, evidence, risks, and open questions. Success means the decision owner, requested decision, source evidence, alternatives, uncertainty, and consequence of no action are all visible; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch,...Votes: 0GitHub stars: 2
- Trial Ops Query Management Change Impact TraceUse when a version, rule, source, or stakeholder change may affect research data-query administration to produce a before/after change record and impact map for the data query aging report. Success means each material difference is tied to affected dependencies, consumers, owners, and a test or explicitly unknown impact; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, and write capabilities only w...Votes: 0GitHub stars: 2
- Trial Ops Query Management Closeout Handoff LedgerUse when a research data-query administration work item is nearing completion, pause, or transfer to another owner to produce a closeout ledger for the data query aging report with status, evidence, owner, and retention state. Success means all deliverables, unresolved items, approvals, and next owners are recorded, and the stop reason is explicit; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, a...Votes: 0GitHub stars: 2
- Trial Ops Query Management Completeness ReconciliationUse when the research data-query administration workflow receives records that must agree across sources, periods, or statuses to produce a reconciliation worksheet for the data query aging report with matched, unmatched, and unresolved rows. Success means counts and key fields reconcile or every variance is quantified, sourced, and left unresolved for an owner; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, br...Votes: 0GitHub stars: 2
- Trial Ops Query Management Exception Triage QueueUse when the research data-query administration workflow has exceptions, missing evidence, or competing priorities to produce a prioritized exception queue for the data query aging report with evidence, owner, and next action. Success means every exception has a severity rationale, source, owner or explicit unassigned state, and a bounded next step; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, ...Votes: 0GitHub stars: 2
- Trial Ops Query Management Recovery Readiness DrillUse when the research data-query administration workflow needs a safe recovery, rollback, replay, or continuity check to produce a recovery-drill record for the data query aging report with starting state, test, and observed outcome. Success means the dry-run or approved non-production drill meets the predeclared recovery target and leaves the baseline intact; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, brow...Votes: 0GitHub stars: 2
- Trial Ops Query Management Scenario Sensitivity MatrixUse when the research data-query administration team needs to compare options under changing assumptions to produce a baseline-plus-scenarios matrix for the data query aging report with assumptions and ranges. Success means the baseline is reproducible, scenario inputs are explicit, comparable units are used, and conclusions state uncertainty; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, and wr...Votes: 0GitHub stars: 2
- Trial Ops Query Management Scope Intake GateUse when a new research data-query administration request needs a bounded work scope to produce a scoped intake card for the data query aging report. Success means owner, objective, permitted sources, acceptance condition, exclusions, and deadline are explicit; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. Record evidence, limit refinemen...Votes: 0GitHub stars: 2
- Trial Ops Query Management Source Provenance LedgerUse when a decision about research data-query administration depends on facts from several records or public sources to produce a source-to-claim provenance ledger for the data query aging report. Success means each material claim has a source, version/date, location, and confidence note; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, read, browser, test, and write capabilities only when relevant and authorized. Reco...Votes: 0GitHub stars: 2
- Trial Ops Query Management Threshold Rule CheckUse when a research data-query administration decision depends on a limit, eligibility rule, policy, or target to produce a rule-check record for the data query aging report showing source, units, boundary case, and outcome. Success means the rule source and effective date are verified, units and scope match, and borderline cases are flagged rather than auto-approved; query status is evidence-backed and no value is changed without the authorized source record. Use configured search, fetch, re...Votes: 0GitHub stars: 2
- Trial Ops Safety Intake Approval Evidence PacketUse when a research safety-event intake administration result is ready for a human owner to approve, reject, or redirect to produce a decision packet for the safety-event routing packet containing options, evidence, risks, and open questions. Success means the decision owner, requested decision, source evidence, alternatives, uncertainty, and consequence of no action are all visible; events are routed on time without severity, causality, or treatment conclusions being generated. Use configure...Votes: 0GitHub stars: 2
- Trial Ops Safety Intake Change Impact TraceUse when a version, rule, source, or stakeholder change may affect research safety-event intake administration to produce a before/after change record and impact map for the safety-event routing packet. Success means each material difference is tied to affected dependencies, consumers, owners, and a test or explicitly unknown impact; events are routed on time without severity, causality, or treatment conclusions being generated. Use configured search, fetch, read, browser, test, and write cap...Votes: 0GitHub stars: 2
- Trial Ops Safety Intake Closeout Handoff LedgerUse when a research safety-event intake administration work item is nearing completion, pause, or transfer to another owner to produce a closeout ledger for the safety-event routing packet with status, evidence, owner, and retention state. Success means all deliverables, unresolved items, approvals, and next owners are recorded, and the stop reason is explicit; events are routed on time without severity, causality, or treatment conclusions being generated. Use configured search, fetch, read, ...Votes: 0GitHub stars: 2
- Trial Ops Safety Intake Completeness ReconciliationUse when the research safety-event intake administration workflow receives records that must agree across sources, periods, or statuses to produce a reconciliation worksheet for the safety-event routing packet with matched, unmatched, and unresolved rows. Success means counts and key fields reconcile or every variance is quantified, sourced, and left unresolved for an owner; events are routed on time without severity, causality, or treatment conclusions being generated. Use configured search,...Votes: 0GitHub stars: 2