Table 2 Curriculum Overview of Clinical Research 1 and Clinical Research 2

Theoretical Classes

1

Clinical Research Overview

Cross-Sectional Study

2

The Ethics of Clinical Research and the Management of Clinical Trial Data

Cohort Study and Case Control Study

3

Common Statistical Methods in Clinical Research

Screening and Diagnostic Tests

4

Clinical Research Design: A Flipped Classroom for Randomized Controlled Trials

Real World Study

Precursor Class

Introduction to the Teaching Plan for the Simulation of Randomized Controlled Trials

Introduction to the Teaching Plan for the Simulation of Cross-Sectional Studies

Simulation Classes

1

Writing A Clinical Trial Protocol I

Writing A Precursor Class Cross-Sectional Study Protocol I

2

Writing A Clinical Trial Protocol II

Writing A Cross-Sectional Study Protocol II

3

Design of Case Report Form

Development of Implementation Manual

4

Review and Approval of Clinical Trials

Project Kick-Off Meeting (Project Training)

5

Registration of Clinical Trials

Field Investigation Workflow (Pilot Investigation, Field Investigation)

6

Generation of Random Sequence

Data Management

7

Drug Blinding

Statistical Analysis of Cross-Sectional Study I

8

Subject Recruitment, Informed Consent, and Random Allocation

Statistical Analysis of Cross-Sectional Study II

9

Source Data Collection and Filling of Case Report Forms

Curriculum Expansion: From Cross-Sectional to Longitudinal Study

10

Management and Report of Adverse Events

Writing A Clinical Research Report

11

Unblinding and Statistical Analysis

Oral Defense