[Company Name]

[Company Group, Division, Location]

Document Title: Human Clinical Studies

Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

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Revision Revision DCO/ECO Revision

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DRAFT DD/MM/Y YY-00000 Draft Author Name
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COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Human Clinical Studies
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

Table of Contents.....................................................................................................................................................1

1.0 Purpose..........................................................................................................................................................2

2.0 Scope.............................................................................................................................................................2

3.0 Responsibilities and Requirements...............................................................................................................2

4.0 Reference Documents...................................................................................................................................2

5.0 Procedure......................................................................................................................................................2

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 2

[Company Name] Human Clinical Studies
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
The purpose of this document is to outline the procedure for conducting human clinical studies.

2.0 Scope
This procedure applies to all human clinical studies conducted using products developed at the [City],
[State] facilities of [Company X].

3.0 Responsibilities and Requirements

[The area, department or position that is responsible for doing human trials].

4.0 Reference Documents

 United States Code of Federal Regulations, Title 21, Part 50; Protection of Human Subjects.
 United States Code of Federal Regulations, Title 21, Part 812; Investigational Device
Exemptions.
 United States Food and Drug Administration (FDA), Medical Device Clinical Study
Guidance.
 European Standard, EN 540; Clinical investigation of medical devices for human subjects.

5.0 Procedure
[Insert procedures for conducting a clinical human trial. Include as appropriate FDA Medical Device
Clinical Study Guidance and the European Standard EN 540 including the design and conduct of the
study protocol].

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 2