Free Sample Clinical Research Proposal Template

Sample Clinical Research Proposal


Researcher: [Your Name]

Date: [Date]


I. Introduction

This proposal outlines a clinical study aimed at evaluating the effectiveness of a new medical intervention. The study will follow a structured approach, focusing on testing specific hypotheses while ensuring patient safety and adherence to ethical guidelines.

II. Objectives

  • Primary Objective: To assess the safety and efficacy of the new intervention in reducing symptoms of the targeted condition.

  • Secondary Objective: To gather additional data on long-term effects and patient satisfaction with the treatment.

III. Methodology

  • Study Design: Randomized Controlled Trial (RCT).

  • Study Population: Adult participants aged 18-65 with the specified condition, meeting inclusion criteria.

  • Intervention: Administer the treatment at a specified dosage and frequency.

  • Data Collection: Regular assessments using surveys, lab tests, and clinical evaluations.

  • Data Analysis: Statistical analysis using t-tests and regression to compare treatment groups.

IV. Ethical Considerations

  • Informed Consent: All participants will provide signed informed consent.

  • Risk-Benefit Assessment: The study will proceed only if the benefits are expected to outweigh any risks.

  • Confidentiality: Participant data will be anonymized and securely stored.

  • Ethical Approval: Approval will be obtained from an Institutional Review Board (IRB).

V. Budget

Category

Estimated Cost

Personnel

$40,000

Equipment

$8,000

Supplies

$4,000

Data Management

$5,000

Analysis

$7,000

Total

$64,000

VI. Timeline

Phase

Duration

Preparatory

1 month

Recruitment

3 months

Data Collection

5 months

Analysis

2 months

Reporting

1 month

Total Duration

12 months

VII. References

  • Smith, J. (2050). Clinical Research Methodology. New York: Medical Press.

  • Johnson, L. & Brown, K. (2051). Ethical considerations in clinical trials. Journal of Medical Ethics, 45(1), 123-130.


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