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Time Series, Health & Evidence Synthesis · Clinical Research & Protocols

Clinical research: Industry standards, documentation, and reporting

Public introduction · full guide in Eikos

Introduction

What this guide covers

Introduction Introduction Industrial Reference Guide

Overview

Topics covered

  • Introduction
  • Clinical Research Standards: Data, Regulation and Biostatistics
  • Global Regulatory Frameworks and ICH-GCP
  • The ICH E6(R2) Guideline and the Evolution to Version E6(R3)
  • FDA (21 CFR) and EMA (Regulation 536/2014) regulations
  • Biostatistical Design Methodology

Related concepts

Main connections

  • Missing data & multiple imputation
  • Survival analysis & Kaplan-Meier
  • Calculus & differentiation
  • Variance & standard deviation
  • Clinical trials & RCT design
  • Confidence interval

Compatible notation

Mathematical sample in LaTeX

The expression is rendered accessibly, with its LaTeX source preserved below.

H0:μTest−μControl≤−Δfrente aH1:μTest−μControl>−Δ
View LaTeX sourceH_0: \mu_{\text{Test}} - \mu_{\text{Control}} \leq -\Delta \qquad \text{frente a} \qquad H_1: \mu_{\text{Test}} - \mu_{\text{Control}} > -\Delta