Your Easy Guide to Clinical Studies

Writing a study protocol follows a set of formal structures that include a:

• Study title
• Title and signature page
• Table of content
• List of abbreviations
• Synopsis
• Scientific Content
• List of references
• List if appendices

 

The title and signature page(s) include:

• The study title
• Study registration / identification number
• Name address of the SP-INV (study responsible)
• Study type (e.g. risk-category, study phase, clinical non-clinical)
• Name of the investigational product (e.g. IMP/IMD)
• For a multi-centre study, name and address of participating Site-INVs (site responsible) 

 

A synopsis, which:

• Is a brief summary of a planned study, downsized to only one or two pages
• Provides a better study oversight than a full protocol with hundreds of pages
• Must not contradict the protocol or other study relevant documents (i.e. essential documents)
• Stands on its own and makes no reference to the full protocol

As a SP-INV:

• Select a protocol template applicable to your study from the swissethics homepage (i.e. templates provide the required formal protocol structures)
• Name your protocol and ensure the document remains clearly identifiable (e.g. author, protocol version number, page number, date of release)

 

When deciding on the protocol title ensure it:

• Conveys the idea or aim of your study. This will “set the stage” from the very beginning
• Is different from other or similarly named studies
• Includes the target population
• Includes the overall study design
• Includes relevant keywords needed for search engines to locate the study
• Is limited to 12 – 15 words (i.e. a good title uses a minimum of words to describe the main study idea)

 

By including all relevant information, a full study title can be rather long, making referencing difficult. Thus, provide the study with an added but much shorter title, or give it a catchy acronym.  

External Links

Swissethics – see in particular

• Templates / Checklists / “Flowchart to assist with the use of the template”
• Templates / Checklists / Study protocols / Requirement for study protocols according to HRA

 

References

ICH GCP E6(R2) – see in particular guideline

• 2.0 Principles of ICH GCP

ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

• 4 Summary of GCP principles
• 68 Clinical investigation planning, conduct and termination

SAMW – see in handbook ”Research with Human subjects”