Your Easy Guide to Clinical Studies

A protocol 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 (statistics and the 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 and 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

 

Consult applicable experts, such as:

• A data manager for the development of the study database
• A statistician for the evaluation of study results (e.g. sample size calculation / blinding / interim and final analysis)
• A monitor for quality control

More

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  guidelines

• 1.44 Protocol definition

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 Scientific relevant topic
• Art. 10 Scientific requirements
• Art. 11 Protection of participants / Subsidiary
• 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