Clinical Documentation¶

1. TITLE PAGE
2. PROTOCOL SUMMARY
3. TABLE OF CONTENTS
4. LIST OF ABBREVIATIONS
5. INTRODUCTION AND RATIONALE
6. STUDY OBJECTIVES
   6.1 Primary Objective
   6.2 Secondary Objectives
7. STUDY DESIGN
   7.1 Overall Design
   7.2 Study Schema
   7.3 Duration of Participation
8. STUDY POPULATION
   8.1 Inclusion Criteria
   8.2 Exclusion Criteria
9. STUDY TREATMENTS
   9.1 Investigational Product
   9.2 Dosing and Administration
10. STUDY ASSESSMENTS
    10.1 Efficacy Assessments
    10.2 Safety Assessments
11. ADVERSE EVENTS
12. STATISTICAL CONSIDERATIONS
13. ETHICAL CONSIDERATIONS
14. ADMINISTRATIVE PROCEDURES

## 6. Study Objectives

### 6.1 Primary Objective

To evaluate the efficacy of [Drug] compared to placebo in
reducing [specific measure] in patients with [condition].

### 6.2 Secondary Objectives

- To assess the safety and tolerability of [Drug]
- To evaluate the effect of [Drug] on [secondary measure]
- To characterize the pharmacokinetic profile of [Drug]

## 8. Study Population

### 8.1 Inclusion Criteria

Patients must meet ALL of the following criteria:

1. Male or female, aged 18 to 65 years
2. Confirmed diagnosis of [condition] according to [criteria]
3. [Specific disease measure] score ≥ X at screening
4. Stable medication regimen for at least 4 weeks
5. Able to provide written informed consent

### 8.2 Exclusion Criteria

Patients meeting ANY of the following will be excluded:

1. History of hypersensitivity to [drug class]
2. Current use of prohibited medications (see Section 9.4)
3. Pregnant or breastfeeding women
4. Severe hepatic impairment (Child-Pugh Class C)
5. Participation in another clinical study within 30 days

# INFORMED CONSENT FORM

Study Title: [Full protocol title]
Protocol Number: [Number]
Sponsor: [Company name]
Principal Investigator: [Name, credentials]

## INTRODUCTION

You are being asked to participate in a research study. Before
you decide, it is important that you understand why the research
is being done and what it involves. Please read this information
carefully and ask questions if anything is unclear.

## PURPOSE OF THE STUDY

This study is testing a new medication called [Drug] for the
treatment of [condition]. The purpose is to find out if [Drug]
is safe and effective compared to a placebo (inactive treatment).

## WHAT WILL HAPPEN IN THIS STUDY

If you agree to participate:

1. **Screening Visit** (about 2 hours)
   - Medical history review
   - Physical examination
   - Blood and urine tests

2. **Treatment Period** (12 weeks)
   - Take study medication once daily
   - Visit the clinic every 4 weeks
   - Complete questionnaires

3. **Follow-up Visit** (4 weeks after treatment)
   - Final assessments
   - Safety evaluation

## RISKS AND SIDE EFFECTS

Common side effects (occurring in more than 10% of patients):
- Headache
- Nausea

Less common side effects (occurring in 1-10% of patients):
- Dizziness
- Fatigue

[Continue with all relevant risks]

## POTENTIAL BENEFITS

You may or may not benefit from participating. Possible benefits
include improvement in your [condition] symptoms.

## ALTERNATIVES

You do not have to participate. Alternative treatments for your
condition include [list alternatives].

## VOLUNTARY PARTICIPATION

Your participation is completely voluntary. You may refuse to
participate or withdraw at any time without affecting your
medical care.

## CONFIDENTIALITY

Your records will be kept confidential. Your name will not appear
in any publication resulting from this study.

## CONSENT

I have read this consent form and have had the opportunity to ask
questions. I voluntarily agree to participate in this study.

________________________    ____________
Participant Signature        Date

________________________    ____________
Person Obtaining Consent     Date

# Too Technical
The pharmacokinetic profile demonstrates first-order elimination
with a mean terminal half-life of 12.4 hours.

# Patient-Friendly
After you take the medication, it stays in your body for about
12 hours before being eliminated.

## Baseline Assessment

**Visit Date**: __ __ / __ __ __ / __ __ __ __
                DD    MMM    YYYY

**Was the patient fasting for this visit?**
○ Yes  ○ No

**Vital Signs**

| Parameter | Value | Unit |
|-----------|-------|------|
| Systolic BP | ___ | mmHg |
| Diastolic BP | ___ | mmHg |
| Heart Rate | ___ | bpm |
| Temperature | ___ | °C |
| Weight | ___ | kg |

**Was the primary endpoint assessment completed?**
○ Yes  ○ No → If No, provide reason: _______________

# Study Reference Manual

## 1. Study Overview
Brief description of study design and objectives.

## 2. Study Personnel
Roles and responsibilities of study team members.

## 3. Subject Management
- Screening procedures
- Enrollment process
- Visit schedules
- Protocol deviations

## 4. Study Procedures
Detailed instructions for each assessment.

## 5. Adverse Event Reporting
- Definitions
- Assessment procedures
- Reporting timelines

## 6. Data Management
- CRF completion guidelines
- Query resolution process