Basic↦Protocol↦Study Protocol↦Aim
What is it? Why is it important?
The aim of a study protocol, also referred to as a Clinical Investigational Plan in Medical Device studies, is to provide a detailed description of a planned study or research project.
Descriptions include the:
- Background and rational of the study
- Research question (e.g. study hypothesis, study outcome / endpoint, expected benefit)
- Study design (e.g. methodology, randomisation, intervention and control group)
- Study population (e.g. population descriptive)
- Safety considerations (e.g. study risk-benefit-ratio)
- Statistical analysis plan
- Authorities (e.g. Ethics Committee (EC), Swissmedic, FOPH, international authorities), laws (e.g. HRA, HRO, ClinO, ClinO-MD, data protection act), and regulations (e.g. ICH-GCP, ISO 14155, ISO 20916) under which a study will be conducted
- Data confidentiality (i.e. storage of health related data and biological material)
- Quality aspects (e.g. SOPs, WIs)
Prior to implementation, the protocol/CIP is reviewed and approved by the EC, and if applicable other regulatory authorities (e.g. Swissmedic (risk-category B and C), FOPH or international).
Once approved, the SP-INV, Site-INV, and project leader must ensure protocol / CIP specifications are complied with during study / project conduct.
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Important incentives of having a well-defined protocol/CIP would be to:
- Convince others of the value and importance of one´s study or research project
- Provide transparency with standardize methods allowing for a successful replication by other researchers
- Facilitate the assessment of study results through peer reviews (evaluation by persons with same competence)
What do I need to do?
As a SP-INV or project leader, you are responsible for the write up of the study protocol/CIP. In the protocol you describe what you want to do in the study, why you want to do it, and how you plan to do it.
Ensure your study:
- Is described in a clear, concise and operationally feasible protocol.
- Is designed in such a way as to;
When writing a protocol/CIP:
- Only use templates that have been approved by swissethics. For international studies, different protocol templates may apply (i.e. refer to the Swiss protocol appendix to cover Swiss requirements)
- Preferably use the English language in order to reach an international audience
- Select qualified staff to support you in the write-up of the protocol/ICIP (e.g. statistician, monitor, data manager, regulatory expert)
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Changes to an already approved protocol/CIP require the submission of a protocol/CIP amendment and approval by EC and as applicable Swissmedic.
When working with an international protocol template, consider a Swiss Appendix to the protocol to cover the required national descriptions from the respective swissethics template.
Protocol/CIP deviations during study conduct must be handled by a SP-INV or project leader without delay.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
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
SPIRIT – see in particular
- SPIRIT Statement
- Checklist
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: Protocol definition
- Appendix B. Clinical trial protocol and protocol amendment(s)
ICH GCP E8(R1) – see in particular guidelines:
- 2.2 Scientific approach to study planning and implementation
ISO 14155:2020 Medical device (access liable to cost) – see in particular sections
- 6.4 Clinical Investigational Plan (CIP)
- Annex A CIP
Declaration of Helsinki – see in particular principles
- 21-22 Protocol requirements
Swiss Law
HRA – see in particular articles
- Art. 5 Scientifically relevant topic
- Art. 10 Scientific requirements
- Art. 11 Protection of participants / Subsidiarity
- Art 12 Protection of participants / Risks and burdens
- Art. 15 Safety and protective measures
ClinO – see in particular articles
- Art. 5 Rules of Good Clinical Practice
- Art. 18 Storage of health-related data and biological material
- Art. 19, 20, 49, and 61 Categorisation
- Art. 29, 34, 55 Changes
ClinO-MD – see in particular article
- Art. 6 Categorisation of clinical investigations
- Art. 15 Modifications
HRO – see in particular article
- Art. 5 Storage of health-related data and biological material
- Art. 7 Categorisation
- Art. 18 Changes