What is it? Why is it important?
The protocol is the core document that describes the background, rationale, objective(s), design, statistical method, including safety aspects of a study.
By approving and signing the study protocol, the SP-INV, including any participating Site-INV(s) and other potential signees (e.g. statistician) confirm their commitment to conduct the study according to:
- Specifications given in the protocol
- The Declaration of Helsinki
- If applicable ICH-GCP guidelines
- ISO 14155 for studies with medical device
- The Swiss law (e.g. data protection laws, HRA, ClinO, ClinO-MD, HRO)
A protocol must have clearly marked identifiers (e.g. protocol version number, release date). In the event of protocol changes or amendments, requires that identifiers are adapted accordingly. This is important as ECs or RAs who approve study protocols, does this on the basis of a particular protocol version.
A given protocol version does not only define how to conduct a study, but is also the basis for any audits or inspections by a SP-INV or RA (e.g. Swissmedic), respectively.
What do I need to do?
As a SP-INV:
- Select and download the official protocol template applicable to your study from the swissethics webpage
- Fill in all required study information (e.g. rational, study design, safety issues)
- Include reviews by applicable experts who contribute to its content (e.g. statistician, quality-, project-, data manager, study nurse)
- Consider to have the protocol reviewed by an impartial expert who can provide important professional support
- Place the synopsis at the beginning of the protocol
Invest sufficient time in protocol development, as a well prepared and thought through protocol will:
- Avoid unexpected difficulties, requiring protocol amendments due to protocol inconsistencies during study conduct
- Save not only resources and costs, but also the required time needed to complete the study (e.g. amendments are costly and do significantly delay the study)
For more information refer to Protocol in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.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 Changes
HRO – see in particular articles
- Art. 7 Categorisation
- Art. 18 Changes