Clinical Protocol Template for ClinO - Chapter 4 Other Clinical Trials - v2.4

Sep 1, 2026

Upload by Cart

Clinical Protocol Template for ClinO provides structured guidance for drafting protocols for other interventional clinical trials under Swiss human research law. It specifies the legal basis, study scope exclusions related to drugs, devices, transplants, gene therapy, and pathogenic organisms, and defines intervention for trial participants. The template includes requirements for participant group representation by gender and age, sex and gender considerations, gender-neutral writing, and standardized headers. It also covers submission via BASEC in searchable OCR PDFs, signature and electronic signature acceptance conditions, confidentiality statement placeholders, and protocol sections for study identifiers, risk categorisation, registry information, and signatures aligned with ICH-GCP and local requirements.

LanguageEnglish

CategoryForms

FormatDOCX

Pages23

Reading Time8 min

AccessFree to download

General information and instructions

Legal basis and intended study scope

Language, participant representation, and sex/gender requirements

Document formatting, submission, and signatures

Protocol title and study metadata

Study type, risk categorisation, registration, and investigators

Confidentiality statement

Protocol signature form

Clinical Protocol Template for ClinO, Chapter 4 «Other Clinical Trials» General information and instructions Legal basis for other clinical trials The laws applicable in this template are the Federal Act on Research involving Human Beings (HRA) and its applicable ordinance (ClinO e/KlinV d/OClin f/OSRUm i) and the ICH-GCP guideline. The template is intended for studies: which are interventional clinical trials according to the definition given in HRA, Art. 3 lit. I and fall into the scope of ClinO Chapter 4 other clinical trials*, performed in Switzerland, respectively where the Investigator is located in Switzerland, (possibly there are additional international sites) where the study question does not relate to the use of drug(s), medical device(s), transplant products, gene therapy, genetically modified or pathogenic organisms and transplantation effect(s), but to other kinds of medical, psychological, physiological interventions or other procedures, * Intervention means any action performed on the trial participant whose effect on that person shall be investigated. For multicenter studies, the language used in the protocol should be English. For monocentric studies the protocol may also be written in a national language, i.e. German, French or Italian, even though the template is in English. Ensure that the criteria for selecting the persons intended to participate and the trial design allow an appropriate representation of the groups of persons who are relevant for answering the scientific question; in particular, they must take into account the distribution of genders and age groups. All applications submitted to the Ethics Committee should also address the issue of sex and gender (unless totally irrelevant). Based on the recommendations “sex and gender in research involving humans according to the HRA” (swissethics.ch / topics / sex and gender equitable research), a set of instructions has been elaborated by a group of experts to guide researchers in the writing of their research documentation, including a grid inspired by the SAGER guidelines. Researchers need to know that the check-up grid provided in the instructions are used by ethics committees’ members to review all protocols and related documents. Please use the text passages that are written in black. Please delete all instructions and explanations that are written in blue, including this page and the table ‘Change History’. Write the protocol in a gender-neutral language. Header and footer should contain the following information on all pages: [Study ID], [version x, DD/MM/YYYY], [Page x of xx]. In places where the information is redundant, it is acceptable to refer to another section or to state its redundancy but the section must not be deleted. The protocol must be submitted via BASEC in an Optical Character Recognition (OCR) PDF format, i.e. in a searchable PDF format. The protocol has to be signed by the principal investigator, the sponsor (if applicable) and in case of a multicentric project by the different local principal investigators as well. Electronic signatures are accepted under the following conditions: The service provider used for the electronic signature process must have a system that verifies that the electronic signature is correct and genuine and properly embedded in the document. Copy-paste of scanned signatures are not accepted. If the protocol is signed by hand, the scans of the wet-ink signed signature pages are uploaded to BASEC separately. Refer questions regarding use of this template to swissethics, HYPERLINK "mailto:info@swissethics.ch" info@swissethics.ch. Be aware that the content of the protocol has to be identical to the content of the BASEC research study application form. You can refer to the trial protocol in the research study application form in BASEC to avoid redundancies but not vice versa. Change history ( Please remove the ‘General information and instructions’ and the table ‘Change history’ ( Protocol Title

FAQs

What legal framework governs this Clinical Protocol Template for other clinical trials?

The template is based on the Federal Act on Research involving Human Beings (HRA) and its applicable ordinance, together with the ICH-GCP guideline.

Which studies are covered by the template under ClinO Chapter 4?

It applies to other interventional clinical trials under HRA definition, in scope of ClinO Chapter 4 other clinical trials, conducted in Switzerland (or with investigator locations in Switzerland), and not related to drugs, medical devices, transplant products, gene therapy, genetically modified or pathogenic organisms, or transplantation effects.

How should the protocol be submitted and signed for BASEC?

Submit via BASEC as a searchable OCR PDF. The protocol must be signed by the principal investigator and sponsor (if applicable), and by local principal investigators for multicenter projects; electronic signatures are accepted only when the provider verifies authenticity and embeds the signature correctly.

Sep 1, 2026

Upload by Cart