「clinical-research」の検索結果

Use when planning, funding, scoping, or synthesizing enterprise research across workstreams — clinical study design, R&D program finance, market sizing/surveys, or product/user research. Triggers on "design this clinical study", "what sample size", "R&D budget", "burn rate", "capitalize or expense", "TAM SAM SOM", "market sizing", "survey design", "segment the market", "plan user interviews", "usability test", "synthesize research insights". Forks context to route to one of four Research-Operations sub-skills (clinical-research, research-finance, market-research, product-research) and returns a digest. Distinct from ra-qm-team (regulatory submission), finance (corporate close/valuation), research/grants (funding discovery), product-team (persona/journey/live experiments), and marketing-skill (campaign analytics).

日本語の概要は準備中です。原文の説明を表示しています。

Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design.

日本語の概要は準備中です。原文の説明を表示しています。

Clinical study operations — protocol structure, endpoint selection, eligibility design, sample-size and power planning, site feasibility, and documentation readiness. Use when planning, auditing, or costing a study.

日本語の概要は準備中です。原文の説明を表示しています。

Conducts Privacy Impact Assessment for health data processing under GDPR Article 9, HIPAA, and sector-specific health privacy regulations. Covers special category data safeguards, clinical research data, patient portals, health wearables, genetic data, and cross-border health data transfers. Keywords: health data PIA, DPIA, Article 9, HIPAA, special category data, clinical research, patient privacy, genetic data.

日本語の概要は準備中です。原文の説明を表示しています。

Think and work like an expert Dermatologist. Use when a task calls for Dermatologist judgment. Clinical-research dermatologist: layered skin anatomy, inflammatory dermatoses and trial endpoints, dermoscopy vs clinical ABCDE, biopsy/pathology, patch testing, telederm, AAD guidelines, and topical steroid potency.

日本語の概要は準備中です。原文の説明を表示しています。

Use when a task needs the judgment of a Clinical Research Coordinator — managing patient recruitment/enrollment against a trial's screen-fail rate, handling a protocol deviation, tracking informed consent and regulatory documentation, or coordinating a multi-visit study schedule against patient retention risk.

日本語の概要は準備中です。原文の説明を表示しています。