Your Easy Guide to Clinical Studies

A Protocol or Clinical Investigation Plan (CIP) (i.e. definition used in Medical Device studies) describes the scientific, safety, and management aspects of a study. Once defined, they outline the rules of the study that must be complied with during study conduct.  

 

Scientific aspects describe study:

• Background, rational, and scientific relevance
• Population
• Research question
• Outcome / endpoint
• Design (i.e. sample size calculation, randomisation)
• Statistical analysis (e.g. analysis plan, interim analysis)

 

Safety aspects describe study:

• Risk categorisation
• Risk-benefit ratio
• Participant protection (e.g. safety and protective measures)
• Data confidentiality (i.e. storage of health related data and biological material)

 

Management aspects describe study:

• SP-INV and if applicable Site-INV(s) responsibilities
• Applicable laws and guidelines
• Potential conflict of interest
• Participant rights (e.g. informed consent, data confidentiality)
• Partners (e.g. data manager, monitoring, statistician, laboratories, data safety monitoring board)
• Quality assurance (e.g. qualified staff, availability of resources, data quality, monitoring, audits)
• Amendment
• Notification of study termination
• Insurance
• Funding
• Study registration and publication responsibilities
• Archiving

As a SP-INV describe:

• Based on a literature search, the background, rational, and scientific relevance of your study. A search provides the arguments needed to justify the conduct of your study, such as what:
  • Is currently known about the IMP/IMD under investigation (e.g. preclinical and clinical evidence)
  • What research questions remain open to be investigated
• The selection and justification of your study population (e.g. inclusion / exclusion criteria, diagnosis, age range, gender)
• The investigational product (i.e. IMP/IMD)
• The study outcome(s) / endpoint(s). Outcome(s) must be measurable and relevant to the research question
• The study design, which must be fit for purpose, providing explanatory power

 

Ensure your study is designed in such a way as to be operationally feasible. In addition:

• Minimize unnecessary complexities to your study
• Mitigate or eliminate risks to the rights, safety, and well-being of study participants
• Ensure study processes guarantee the quality of your study data

 

When writing the protocol consider inputs from interested parties, such as health care professionals and patient perspective.

Mehr

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
• II. Principles of ICH GCP Nr. 8 the study protocol
• Appendix B1-B16. Content of a trial protocol

ICH GCP E8(R1) – see in particular guidelines:

• 2.3 Patient Input into drug development
• 5. Design and data source for clinical studies
• 5.1 Study population

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 

ClinO-MD – see in particular article

• Art. 6 Categorisation of clinical investigations

HRO – see in particular article

• Art. 5 Storage of health-related data and biological material
• Art. 7 Categorisation