Concept↦Documents↦Required Documents↦Protocol and Synopsis
What is it? Why is it important?
The protocol is the core document that:
- Describes the study background, rationale, objective(s), outcome(s), design, assessment(s), statistical method(s), including applicable safety aspects
- Lays down the rules for study conduct, that must be complies with by study staff
The protocol synopsis is a short summary of the protocol and provides a kind of roadmap or panoramic view of the planned study.
The protocol is often an extensive document. As a result, the synopsis is often presented when applying for grants or seeking other types of support.
Swissethics provides a selection of mandatory protocol templates. Which template to use depends on study:
- Type with ClinO, ClinO-MD versus HRO studies (e.g. intervention versus other- or non-clinical studies)
- Risk category (A, B or C)
What do I need to do?
As a SP-INV and based on your planned study:
- Start by selecting the applicable protocol template provided by swissethics. The template ensures that you will include all protocol required information. If unsure clarify with EC beforehand
- Consider what additional support or expertise must be recruited for the protocol write-up (e.g. a study statistician, quality-, project-, data manager, an experienced study nurse)
In the protocol evaluate what kind of impact study findings wouls have on public health. In other words, how will study findings contribute to disease prevention and/or contribute to any health improvement of your target population.
For more information refer to Protocol in this Study Guide.
For the development of the study protocol:
- Analyse the particular medical/public health problem under investigation, and include a review of current existing knowledge
- Define the hypothesis and objectives (research question(s)) of your study.
- Calculate the study sample size needed to answer the research question(s)
- Based on the research question(s), choose the appropriate study design
- Decide on achievable and measurable study endpoints (outcome measures), including applicable statistical methods needed for data analysing
- Describe current knowledge regarding IMP/MD safety profiles. Consider the implementation of preventive measures
- Consider the procurement and handling of the IMP/MD
- Determine study visit assessments / study schedule
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissethics – see in particular
- Broad selection of protocol templates
ICH GCP E6(R2) – see in particular guidelines
- 1.44 Protocol definition
- 1.45 Protocol Amendment
- 2.5, 2.6 Principles of ICH-GCP
- 6 Clinical Trial Protocol and Protocol Amendment(s)
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- 6.4 Clinical Investigational Plan (CIP)
- Annex A CIP
Declaration of Helsinki – see in particular principles
- 21 – 22 Protocol requirements
ClinO – see in particular articles
- Art. 19, 20, 49 and 61 Categorisation
- Art. 29 Change
HRO – see in particular articles
- Art. 7 Categorisation
- Art. 18 Change