PHASE 1 CLINICAL TRIAL PROTOCOL

TEMPLATE

[Sponsor Name]

CLINICAL RESEARCH PROTOCOL

[PROTOCOL NAME]

PROTOCOL NO.
VERSION NO.	DATE
PRINCIPLE INVESTIGATOR(S)
RESEARCH TEAM MEMBERS

APPROVED BY:

Principle Investigator or Sponsor Signature and Title	Date

SITE

PROTOCOL AGREEMENT

I have read and understand the protocol below. In my capacity as Investigator, my duties include making sure of the safety of the study participants enrolled under by supervision and providing [PI or SPONSOR NAME] with complete and timely information. This information will be provided as outlined in this study protocol. All the information relating to this study will be held in strict confidence and this confidentiality requirements applies to all staff at this study site or involved with this study. I agree to maintain the procedures required to perform this study in accordance with Good Clinical Practice principles and to abide by the terms of this protocol.

PROTOCOL NO.	PROTOCOL DATE
PROTOCOL TITLE

Investigator Signature	Date

Name and Title (Print)

CONTACT INFORMATION

Table of Contents

PROTOCOL AGREEMENT	2

1.	ABSTRACT	4

2.	BACKGROUND AND SIGNIFICANCE OF PRELIMINARY STUDIES	4

3.	STUDY AIMS	4

4.	ADMINISTRATION	4

5.	STUDY DESIGN	5

6.	Study Procedures	5

SUBJECT SELECTION PROCEDURES	5

RANDOMIZATION PROCEDURES (if applicable)	5

STUDY INTERVENTION	6

7.	SAFETY MONITORING PLAN	6

8.	ANALYSIS PLAN	7

9.	REFERENCES	7

ABSTRACT

Describe the study background, aims, and design.

BACKGROUND AND SIGNIFICANCE OF PRELIMINARY STUDIES

Describe the basis for the proposed research, presenting the problem and a review of the current literature. Also include an evaluation of the current knowledge and any preliminary studies relative to this proposed research. Describe how the research will enhance the current knowledge.

STUDY AIMS

Describe the study purpose, primary objective(s), secondary objective(s), and hypotheses.

ADMINISTRATION

Describe the participating study sites, units, laboratories, data centers, and any coordinating centers applicable.

STUDY DESIGN

Describe the study design, population, sample size, power analyses, anticipated outcomes, and endpoints.

Study Procedures

SUBJECT SELECTION PROCEDURES

Describe the sampling plan, including the inclusion and exclusion criteria, and the recruitment procedures. For the recruitment procedures, describe where recruitment will occur, where and when consent will be obtained, who will obtain consent, describe the advertising plan, and describe the recruitment materials. Finally, describe the screening procedures, including the screening schedule, which procedures are part of standard care versus research purposes, and what happens in screen failures with the subject and the data.

RANDOMIZATION PROCEDURES (if applicable)

STUDY INTERVENTION

For drug or device studies, describe the:

Active study agent(s)

Placebo study agents(s)

Blinding, labeling, agent(s) preparation

Storage

Administration

Toxicities

For other types of studies, describe the:

Intervention

Control group

SAFETY MONITORING PLAN

For the safety monitoring plan, describe the:

Adverse event and serious adverse event definitions.

Subject safety procedures.

How adverse events will be identified, documented, and reported.

The review frequency of safety information summaries and review procedures.

The safety and efficacy stopping rules.

ANALYSIS PLAN

Describe the statistical analysis methods, as appropriate.

REFERENCES

List references and citations in alphabetical order here.

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