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+# Clinical Study Report (CSR) Template
+## ICH-E3 Format
+
+---
+
+# TITLE PAGE
+
+**Study Title:** [Full descriptive title including compound, indication, phase]
+
+**Protocol Number:** [Sponsor protocol number]  
+**Protocol Version:** [Final protocol version and date]
+
+**Sponsor:** [Company name and address]  
+**Compound/Drug Name:** [Generic and proprietary names, compound code]  
+**Indication:** [Therapeutic area and specific indication studied]
+
+**Study Phase:** [I / II / III / IV]  
+**Study Type:** [Interventional / Observational]
+
+**Report Date:** [MM/DD/YYYY]  
+**Report Version:** [Version number]
+
+**Medical Expert:** [Name, MD, Title]  
+**Biostatistician:** [Name, PhD, Title]
+
+**Confidentiality Statement:**
+"This document contains confidential information belonging to [Sponsor]. It may not be reproduced or distributed without permission."
+
+---
+
+# SYNOPSIS
+
+**Title:** [Abbreviated title]
+
+**Protocol Number:** [Number]  
+**Study Phase:** [Phase]  
+**Study Period:** [Start date - End date]
+
+## Study Objectives
+
+**Primary Objective:**
+[State primary objective clearly and concisely]
+
+**Secondary Objectives:**
+- [Secondary objective 1]
+- [Secondary objective 2]
+
+## Methodology
+
+**Study Design:**
+[Randomized, double-blind, placebo-controlled, parallel-group, etc.]
+
+**Study Population:**
+- Target population: [Patient population]
+- Key inclusion criteria: [Main criteria]
+- Key exclusion criteria: [Main criteria]
+
+**Sample Size:**
+- Planned: [N participants]
+- Randomized: [N participants]
+- Completed: [N participants]
+
+**Treatment:**
+- Treatment A: [Drug name, dose, route, frequency]
+- Treatment B: [Comparator/placebo]
+- Treatment duration: [Weeks/months]
+- Follow-up duration: [Weeks/months]
+
+**Endpoints:**
+
+Primary:
+- [Primary endpoint definition and timepoint]
+
+Secondary:
+- [Secondary endpoint 1]
+- [Secondary endpoint 2]
+
+**Statistical Methods:**
+[Brief description of analysis approach, significance level, handling of multiplicity]
+
+## Results
+
+**Participant Disposition:**
+- Screened: [N]
+- Randomized: [N Treatment A, N Treatment B]
+- Completed: [N Treatment A, N Treatment B]
+- Discontinued: [N overall, % - main reasons]
+
+**Demographics and Baseline:**
+[Summary of key baseline characteristics, comparability across groups]
+
+**Efficacy Results:**
+
+Primary Endpoint:
+- [Result for Treatment A vs B, effect size, 95% CI, p-value]
+
+Secondary Endpoints:
+- [Results for each secondary endpoint]
+
+**Safety Results:**
+- Any AE: [% Treatment A vs B]
+- Treatment-related AE: [% Treatment A vs B]
+- Serious AE: [% Treatment A vs B]
+- Discontinuations due to AE: [% Treatment A vs B]
+- Deaths: [N Treatment A vs B]
+- Common AEs (≥5%): [List with percentages]
+
+## Conclusions
+
+[Overall conclusions regarding efficacy and safety, benefit-risk assessment]
+
+---
+
+# TABLE OF CONTENTS
+
+[Detailed table of contents with page numbers]
+
+---
+
+# LIST OF ABBREVIATIONS
+
+| Abbreviation | Definition |
+|--------------|------------|
+| AE | Adverse Event |
+| ANCOVA | Analysis of Covariance |
+| CI | Confidence Interval |
+| CSR | Clinical Study Report |
+| FAS | Full Analysis Set |
+| GCP | Good Clinical Practice |
+| ICF | Informed Consent Form |
+| ITT | Intent-to-Treat |
+| PP | Per-Protocol |
+| SAE | Serious Adverse Event |
+| SD | Standard Deviation |
+| [Add study-specific abbreviations] | |
+
+---
+
+# ETHICS (Section 2)
+
+## 2.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
+
+[List of all IECs/IRBs that approved the study]
+
+| Site Number | Institution | IRB/IEC Name | Approval Date |
+|-------------|------------|--------------|---------------|
+| 001 | [Institution] | [IRB name] | [MM/DD/YYYY] |
+
+## 2.2 Ethical Conduct of the Study
+
+This study was conducted in accordance with:
+- ICH Good Clinical Practice (GCP) E6(R2)
+- Declaration of Helsinki (current version)
+- Applicable regulatory requirements
+- Sponsor Standard Operating Procedures
+
+## 2.3 Patient Information and Consent
+
+Informed consent was obtained from all participants before any study-specific procedures. The informed consent process included:
+- Written information about study purpose, procedures, risks, and benefits
+- Opportunity to ask questions
+- Voluntary participation with right to withdraw
+- Signatures of participant and person obtaining consent
+- Copy provided to participant
+
+---
+
+# INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE (Section 3)
+
+## 3.1 Investigators and Study Centers
+
+[Table listing all investigators, sites, and enrollment]
+
+| Site No. | Investigator | Institution | City, Country | Subjects Enrolled |
+|----------|--------------|-------------|---------------|-------------------|
+| 001 | [Name, MD] | [Institution] | [City, Country] | [N] |
+
+**Coordinating Investigator:** [Name, if applicable]
+
+## 3.2 Study Administrative Structure
+
+**Sponsor:**
+- Medical Monitor: [Name, credentials]
+- Project Manager: [Name]
+- Biostatistician: [Name, credentials]
+
+**Contract Research Organization (CRO):** [Name, if applicable]
+- [Responsibilities]
+
+## 3.3 Responsibilities of Parties Involved
+
+[Description of sponsor, investigator, CRO, DSMB responsibilities]
+
+---
+
+# INTRODUCTION (Section 4)
+
+## 4.1 Background
+
+[Detailed background on disease/condition, unmet medical need, treatment landscape]
+
+## 4.2 Nonclinical Studies
+
+[Summary of relevant preclinical pharmacology, toxicology, and safety findings]
+
+## 4.3 Previous Clinical Studies
+
+[Summary of prior clinical experience with investigational product]
+
+## 4.4 Study Rationale and Objectives
+
+[Justification for conducting this study, specific objectives]
+
+---
+
+# STUDY OBJECTIVES AND PLAN (Section 5)
+
+## 5.1 Objectives and Endpoints
+
+**Primary Objective:**
+[Objective statement]
+
+**Primary Endpoint:**
+[Detailed endpoint definition, measurement method, timepoint]
+
+**Secondary Objectives:**
+1. [Objective]
+2. [Objective]
+
+**Secondary Endpoints:**
+1. [Endpoint definition]
+2. [Endpoint definition]
+
+## 5.2 Study Design
+
+[Detailed description of study design with diagram if helpful]
+
+**Design Type:** [Parallel, crossover, factorial, etc.]
+**Blinding:** [Double-blind, open-label, etc.]
+**Randomization:** [1:1, 2:1, stratified, etc.]
+**Duration:** [Treatment period, follow-up period]
+
+**Study Schema:**
+[Flow diagram showing screening, randomization, treatment periods, follow-up]
+
+## 5.3 Study Population
+
+**Key Inclusion Criteria:**
+1. [Criterion]
+2. [Criterion]
+
+**Key Exclusion Criteria:**
+1. [Criterion]
+2. [Criterion]
+
+## 5.4 Treatments
+
+**Investigational Product:**
+- Name: [Generic, trade, code]
+- Formulation: [Tablet, capsule, injection]
+- Dose: [Dose and regimen]
+- Route: [PO, IV, SC, etc.]
+- Packaging and labeling: [Description]
+
+**Comparator:**
+[Similar details for comparator or placebo]
+
+**Concomitant Medications:**
+[Permitted and prohibited medications]
+
+## 5.5 Sample Size Determination
+
+**Target Sample Size:** [N per group, N total]
+
+**Justification:**
+- Assumed effect size: [Value]
+- Variability (SD): [Value]
+- Type I error (α): [0.05]
+- Power (1-β): [80% or 90%]
+- Expected dropout rate: [%]
+- Two-sided test
+
+## 5.6 Statistical Analysis Plan
+
+**Analysis Populations:**
+- Full Analysis Set (FAS): [Definition]
+- Per-Protocol Set (PPS): [Definition]
+- Safety Analysis Set: [Definition]
+
+**Statistical Methods:**
+- Primary endpoint: [Method - e.g., ANCOVA with baseline as covariate]
+- Secondary endpoints: [Methods]
+- Handling of missing data: [Approach]
+- Multiplicity adjustment: [Method if applicable]
+- Interim analyses: [If planned]
+
+**Significance Level:** α = 0.05 (two-sided)
+
+---
+
+# STUDY PATIENTS (Section 6)
+
+## 6.1 Disposition of Patients
+
+**Participant Flow (CONSORT Diagram):**
+
+[Include detailed CONSORT diagram showing screening through analysis]
+
+**Summary Table:**
+
+| Category | Treatment A | Treatment B | Total |
+|----------|-------------|-------------|-------|
+| Screened | N | N | N |
+| Screen failures | N (%) | N (%) | N (%) |
+| Randomized | N | N | N |
+| Received treatment | N (%) | N (%) | N (%) |
+| Completed | N (%) | N (%) | N (%) |
+| Discontinued | N (%) | N (%) | N (%) |
+| - Adverse event | N (%) | N (%) | N (%) |
+| - Lack of efficacy | N (%) | N (%) | N (%) |
+| - Lost to follow-up | N (%) | N (%) | N (%) |
+| - Withdrawal of consent | N (%) | N (%) | N (%) |
+| - Other | N (%) | N (%) | N (%) |
+
+## 6.2 Protocol Deviations
+
+**Major Protocol Deviations:**
+[Summary of major deviations, impact on data, subjects affected]
+
+**Important Protocol Deviations by Category:**
+
+| Deviation Type | Treatment A | Treatment B | Total |
+|----------------|-------------|-------------|-------|
+| Inclusion/exclusion criteria | N (%) | N (%) | N (%) |
+| Dosing errors | N (%) | N (%) | N (%) |
+| Prohibited medications | N (%) | N (%) | N (%) |
+| Missed visits | N (%) | N (%) | N (%) |
+
+---
+
+(Continues with sections 7-14 following ICH-E3 structure...)
+
+---
+
+**Note:** This is an abbreviated template. A complete CSR following ICH-E3 is typically 50-300 pages with extensive appendices. Key sections to complete:
+- Section 7: Efficacy Evaluation
+- Section 8: Safety Evaluation
+- Section 9: Discussion and Overall Conclusions
+- Section 10: Tables, Figures, and Graphs
+- Section 11: References
+- Section 12-14: Appendices (Protocol, CRFs, Investigator list, etc.)
+
+