Your Easy Guide to Clinical Studies

The study protocol is the core document, that based on a research question, desribes the background, rationale, objective(s), design, statistical method, and safety aspects (e.g. risk-benefit ratio) of a study.

 

The protocol lays down “the rules” of the study. Once approved by the Ethics Committee (EC) and, if applicable, RA (e.g. Swissmedic, FOPH, international), the SP-INV, study staff, including participating study sites (i.e. Site-INV, site staff) are required to comply with its specifications.

 

Changes to a protocol require a protocol amendment, which must be re-submitted for approval. Only if changes are approved can the amendment be implemented.

 

In addition to specifications in the study protocol, researchers must comply with:

• The Swiss laws (e.g. HRA)
• The Declaration of Helsinki
• The principles of ethics
• ICH GCP guidelines for ClinO studies
• ISO 14155 for ClinO-MD studies
• ISO 20916 for In-Vitro-Diagnostic Medical Device studies

It is advisable to invest sufficient time in the development of the study protocol. Starting with a well thought through protocol will prevent the realisation of protocol inconsistencies during study conduct.

A protocol correction or amendment may require added resources, additional time until study completion, and most likely an increase in study costs.

 

As a SP-INV, access the protocol section of the Easy-GCS to get support on how to write your study protocol. The following aspects are discussed:

 

Formal Protocol Structure:

• Requirements
• Protocol template

 

Writing the Protocol:

• Content
• Responsibilities

 

Study Participants;

• Participant risks
• Participant right

External Links

Swissethics – see in particular

• Broad selection of protocol templates

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: Definition protocol
• II. Principles of ICH GCP Nr. 8 the study protocol
• Appendix B. Clinical trial protocol and protocol amendment(s)

ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections

• 6.4 Clinical Investigational Plan (CIP)
• Annex A CIP

Declaration of Helsinki – see in particular principles

• 21 – 22 Protocol requirements

SAMW – see in handbook ”Research with Human subjects”

Swiss Law

ClinO – see in particular articleand annexes

• Art. 29 Changes
• Annex 3 Application documents for EC
• Annex 4 Application documents for Swissmedic

ClinO-MD - see in particular article and annex

• Annex 1 application documents for study approval
• Art. 15 Changes

HRO – see in particular article and annex

• Art. 18 Changes
• Annex 1 application documents to EC