M11 CLINICAL ELECTRONIC 
STRUCTURED HARMONISED 
PROTOCOL  
(CESHARP)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page.  The draft guidance has been left in the original 
International Council for Harmonisation format.  The final guidance will be reformatted and edited to 
conform with FDAs good guidance practice regulation and style. 
 
 
 
 
 
 
  
 
 
For questions regarding this draft document, contact (CDER) Veronica Pei, 240-402-7091, 
Veronica.Pei@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
   
 
FOREWORD 
 
 
 
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to 
ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in 
the most resource-efficient manner.  By harmonizing the regulatory expectations in regions around 
the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented 
unnecessary animal studies, standardized safety reporting and marketing application submissions, 
and contributed to many other improvements in the quality of global drug development and 
manufacturing and the products available to patients.  
 
 
 
ICH is a consensus-driven process that involves technical experts from regulatory authorities and 
industry parties in detailed technical and science-based harmonization work that results in the 
development of ICH guidelines.  The commitment to consistent adoption of these consensus-based 
guidelines by regulators around the globe is critical to realizing the benefits of safe, effective, and 
high-quality medicines for patients as well as for industry.  As a Founding Regulatory Member of 
ICH, the Food and Drug Administration (FDA) plays a major role in the development of each of the 
ICH guidelines, which FDA then adopts and issues as guidance to industry.  
 
 
 
 
 
   
   
 
 
   
 
 
 
 
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL 
REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 
 
 
 
 
 
ICH HARMONISED GUIDELINE 
 
 
 
 
 
CLINICAL ELECTRONIC STRUCTURED HARMONISED 
PROTOCOL 
(CESHARP) 
 
M11 
 
Draft version 
 
Endorsed on 27 September 2022 
 
Currently under public consultation 
 
 
 
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH 
Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH 
regions for internal and external consultation, according to national or regional procedures. 
   
ICH M11 Guideline 
 
 
M11 
Document History 
 
Code  History  Date 
M11  Endorsement by the Members of the ICH Assembly  27 September 
under  Step  2  and  release  for  public  consultation  2022 
(document dated 4 September 2022).  
 
 
 
 
 
 
 
 
 
 
 
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from this copyright holder. 
   
ICH M11 Guideline 
 
ICH HARMONISED GUIDELINE 
STRUCTURE AND CONTENT OF A CLINICAL PROTOCOL 
M11 
ICH Consensus Guideline 
 
 
 
TABLE OF CONTENTS 
1.  INTRODUCTION ............................................................................................................... 1 
1.1  Background ........................................................................................................................... 1 
1.2  Purpose .................................................................................................................................. 1 
1.3  Scope ..................................................................................................................................... 2 
2.  GENERAL DESIGN PRINCIPLES .................................................................................. 2 
2.1  Clinical Electronic Structured Harmonised Protocol - Template .......................................... 2 
2.2  Clinical Electronic Structured Harmonised Protocol - Technical Specification ................... 3 
3.  TEMPLATE CONVENTIONS AND DESIGN ................................................................. 4 
 
 
 
 
 
   
ICH M11 Guideline 
 
1  1.  INTRODUCTION 
2  1.1  Background 
3  The clinical protocol describes the processes and procedures directing the conduct and analysis of 
4  a clinical trial of medicinal product(s) in humans. To date, no internationally adopted harmonised 
5  standard has been established for the format and content of the clinical protocol to support 
6  consistency across sponsors and for the electronic exchange of protocol information.    
7  Variability in format and core content among sponsors contributes to inefficiencies and difficulties 
8  in searching, reviewing, and assessing clinical trial protocols. Use of the clinical trial protocol 
9  template aids the sponsor or sponsor-investigator in the development of a protocol that is complete, 
10  free from ambiguity, well organised, and aligned with quality by design principles as set forth in 
11  other ICH guidelines. By conveying information consistently and in the same location across 
12  clinical trial protocols, a protocol template is intended to provide value to parties that include 
13  sponsors, investigators, clinical site personnel, trial participants, ethics committees, and regulators. 
14  A technical specification presenting the business requirements and common structured protocol 
15  content  components  and  an  open,  non-proprietary  standard  for  electronic  exchange  enables 
16  development of interoperable electronic tools to facilitate exchange, review, and execution of 
17  protocols. 
18  1.2  Purpose 
19  The purpose of this guideline is to describe the general protocol design principles and approach 
20  used to develop the separate associated documents, the ICH M11 Clinical Electronic Structured 
21  Harmonised Protocol Template [Template] and the Technical Specification that are acceptable to 
22  all regulatory authorities of the ICH regions. The Template presents the format and structure of the 
23  protocol,  including  the  table  of  contents,  common  headers,  and  contents.  The  Technical 
24  Specification presents the conformance, cardinality, and other technical attributes that enable the 
25  interoperable electronic exchange of protocol content. 
26  Conformance with this Template and Technical Specification should ensure that protocols are 
27  provided in a harmonised data exchange format acceptable to the regulatory authorities. The 
28  Template and Technical Specification have been developed with built-in flexibility and are 
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ICH M11 Guideline 
 
29  versioned documents. As clinical protocol requirements evolve and technology advances, they may 
30  be revised subject to a change control process. 
31  1.3  Scope 
32  The Template and Technical Specification documents supported by this guideline are intended to 
33  assist  stakeholders  (those  who  use  and  exchange  protocol  information,  including  sponsors, 
34  investigators, institutional review boards / ethics committees and regulators in the development, 
35  amendment,  review, conduct, and closeout of  a clinical trial). The Template and  Technical 
36  Specification are applicable to interventional clinical trials of medicinal products across all phases 
37  and therapeutic areas of clinical research. Interventional trials may include but are not limited to 
38  human pharmacology, exploratory, confirmatory, and post-approval studies (see ICH E8(R1) 
39  General Considerations for Clinical Studies). The term medicinal product in this guideline, and 
40  the term trial intervention in the protocol Template refer to any therapeutic, prophylactic, or 
41  diagnostic agent including pharmaceuticals, biologics, vaccines, cell or gene therapy products 
42  (when applicable), as well as drug-device combination products when registered as a drug.  
43  Neither  this  Guideline  nor  the  Template  or  Technical  Specification  are  intended  to  specify 
44  processes related to development and maintenance of a protocol. They do not supersede or negate 
45  other guidelines that establish requirements for protocol content. They neither provide instruction 
46  on either the development of a well-designed trial nor do they characterise a well-crafted final 
47  protocol.  Rather,  the  ICH  M11  Guideline,  Template,  and  Technical  Specification  establish 
48  common instructions for placement of content, as reflected in other prevailing guidelines, as well 
49  as the technical attributes for interoperable electronic exchange of that content. 
50  2.  GENERAL DESIGN PRINCIPLES 
51  2.1  Clinical Electronic Structured Harmonised Protocol - Template 
52  The Template was designed based on general principles that would support a harmonised standard 
53  protocol to facilitate consistency and efficiency in the development, amendment, review, conduct 
54  and closeout of a clinical trial and the exchange of protocol information. Specifically, the principles 
55  include: 
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ICH M11 Guideline 
 
56    Build common core content - The Template design represents a core set of information 
57  for a clinical trial of any medicinal product(s). 
58    Serve  the  needs  of  stakeholders  -  The  Templates  structure  and  content  provide  a 
59  framework for relevant stakeholders to develop, review and use protocols that consistently 
60  and unambiguously include a uniform table of contents, common section headers and 
61  content, as well as common terminologies. 
62    Define content for electronic exchange - The protocol content can be electronically 
63  exchanged among parties, including sponsors and regulators, using current (for example, 
64  electronic common technical document) and other future technologies. 
65    Design for content re-use - The clinical protocol is a rich source of information that can 
66  be re-used as part of the clinical trial management and review process, and, for example, 
67  published on clinical trial registries to promote clinical trial transparency and used in 
68  standardised clinical trial data capture. 
69    Maintain flexibility - The Template incorporates both recommended and optional text and 
70  data fields to maintain flexibility. Higher-level heading structure is conserved, while lower 
71  level sections can be added, removed, or modified as needed. 
72  The Template should be used in conjunction with other ICH Guidelines relevant to the conduct of 
73  clinical trials. 
74  2.2  Clinical Electronic Structured Harmonised Protocol - Technical Specification 
75  The Technical Specification includes detailed descriptions of the structured content components 
76  (for example, specific data fields and blocks of text-based content), along with other defining 
77  attributes and business rules as established in the Template. 
78  The Technical Specification is based on the following design principles: 
79    Promote structured common core content 
80    Define content specifications for electronic exchange 
81    Develop a data model based on specifications 
82    Focus on relevant content use and re-use 
83    Use an open, non-proprietary exchange message standard 
84    Maintain flexibility for technical innovation and region-specific use 
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ICH M11 Guideline 
 
85   
86   
87  3.  TEMPLATE CONVENTIONS AND DESIGN 
88  The Template must obviously enable a final protocol that meets the needs of its diverse audience, 
89  which include investigators, and site staff,  regulatory reviewers, and  sponsor personnel. To 
90  facilitate  efficient  and  accurate  execution,  chief  consideration  was  given  to  the  needs  of 
91  investigators and site staff. Accordingly: 
92    The Template is designed with the most vital information for execution (for example, 
93  Synopsis, Schema, Schedule of Activities) near the front. 
94    The Template is organised in a Main Body/Appendix framework, in which trial-specific 
95  information is in the Main Body, while reference details and more general (non-trial-
96  specific) information is in the Appendix. This organisational construct was adopted merely 
97  for its utility during execution. 
98    Content in the Appendix carries equal weight and rigor as the content in the Main Body. 
99    Unnecessary repetition is eliminated wherever possible.  
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