Development↦Protocol↦Writing the Protocol↦Responsibilities
What is it? Why is it important?
The SP-INV is responsible for writing the study protocol. Once finalised, the SP-INV officially approves the protocol by dating and signing the signature page. Other potential collaborators required to date and sign the protocol are the:
- Statistician responsible for the analysis of study results (e.g. statistical analysis plan)
- Site-INV(s) in a multicentre study responsible for a given study site
- Other relevant collaborators (e.g. a medical writer, laboratories analysing biological material, CRO or monitoring institution)
By signing the protocol, both the SP-INV and study collaborators confirm:
- The feasibility of delegated study tasks (e.g. the implementation of the study at a given site, analysis of biological material)
- Data confidentiality (i.e. storage of health related data and biological material)
- Ongoing compliance with the protocol from start to completion
Once signed the protocol:
- Must be approved by the Ethics Committee (EC) and if applicable Swissmedic (e.g. risk-category B and C)
- Is officially registered in a publically accessible registry
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Study registration:
- Is mandatory for interventional studies and highly recommended for observational studies. Several scientific journals only publish interventional studies registered in a clinical trials registry
- Fulfils research transparency and promotes result propagation
- Is updated in accordance with registry requirements, but at least once a year
What do I need to do?
As a SP-INV, write a protocol where:
- The research question is clear, supported by current scientific knowledge
- Ethics and regulatory requirements (e.g. Swissmedic, FOPH) are correctly sited
- Procedures are feasible, clear, and void of unsolicited interpretations (e.g. participant access and recruitment, administration of IMP/IMD, data collection, safety reporting, analysis of study results)
- Internal inconsistencies or mistakes are removed, and all relevant information is included
As a rule, a protocol is written in a manner that allows the study to be reproduced, later or by other researcher(s).
For persons signing the protocol, include contact details (e.g. name, study role, address). In multicentre studies, add a separate signature page for each participating Site-INV.
Aspects to consider:
- Any changes of an EC / Swissmedic approved protocol escalates an amendment
- In order to ensure data quality and participant safety, base the risk-management of your study on the study protocol
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Electronic signatures are only acceptable if based on approved electronic signature procedures
Once approved by EC and if applicable Swissmedic, the protocol becomes binding and must be complied with during study conduct.
Changes to an approved protocol escalates an amendment that requires prior EC / Swissmedic approval. Exception are safety and protective measures needed to protect study participants.
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
Swiss Law
HRA – see in particular articles
- Art. 5 Scientific relevant topic
- Art. 10 Scientific requirements
ClinO – see in particular articles
- Art. 1 d Study registration
- 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. 24 – 29 Procedures for the Ethics Committee
- Art. Art. 23, 27, 31 Procedures for the agency (Swissmedic)
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