Development↦Safety↦Safety Documentation↦The Protocol
Was betrifft es? Warum ist das wichtig?
The study protocol is a document that describes the set-up and implementation of a study.
With respect to safety, the study protocol should include:
- When and how (serious) Adverse Events (AEs) are collected, assessed, documented, reported and managed (e.g. AE in investigational Medicinal Product (IMP) studies, AE/ Device Effect in Investigational Medical Device (IMD) studies)
- Safety outcomes, representing variables that are collected and monitored in order to assess the safety of the study, based on its intervention and/or procedures
The objective of collecting safety data during study conduct, and if applicable study follow-up, is to:
- Ensure study participants are protected from harm
- Maintain safety outcome oversight
- Detect the occurrence of new (serious) safety events, to be added to the therpeutic product’s safety profile (e.g. IB for IMP/IMD, SmPC / PI for marketed MP, IFU for marketed MDs)
- Enable risk-benefit assessments on an ongoing basis
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Safety outcomes should be clearly described in the protocol. They should:
- Cover study relevant safety events (e.g. laboratory parameters, vital signs)
- Have defined thresholds for abnormal values (e.g. acceptable values below or above given parameters)
- Describe causality relationship between AE and study intervention or procedures
- Reflect the dynamic change resulting from the study intervention or procedures (e.g. evolution of AE)
Based on study risk-category, requirement for AE documentation varies. For study risk category:
- C: all AEs are documented in a standardised manner
- B: only AEs mentioned in the protocol or requested by authorities are documented
- A: no obligation of AE documentation exists
Still, irrespective of study risk-category, the documentation and reporting of Serious AEs (SAE / SAE / Serious Device Effect) is mandatory.
Was muss ich befolgen?
As a SP-INV describe:
- Safety endpoint/outcome measures (e.g. laboratory parameters, particular AEs and/or frequency)
- The collection of adverse events and other safety related events
- The timeframe for safety reporting (i.e. recording of AEs in the eCRF)
Define procedures for the:
- Assessment of safety events (e.g. seriousness, severity, expectedness)
- Reporting of Serious AEs (MP-SAEs, MD-SAEs / Serious Device Effect). Reporting is done to the Ethics Committee (EC), and as applicable to Swissmedic, participating Site-INV(s), and marketing authorization holder
Additional documentation includes:
- A clear description, in blinded studies, on how to break the blind
- Study safety termination criteria (e.g. interim analysis, DSMB report)
- The study`s risk-benefit assessment, and how its ratio supports the safe conduct of your study
Study safety management must be documented in a study protocol. Specific safety procedures can be delegated and described in a SOP or WI. The protocol must provide applicable references and the commitment to adhere to its specifications.
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Timeframe for safety reporting (i.e. recording of AEs in the eCRF). Safety reporting:
- Starts when the participant signs the Informed Consent (ICF)
- Ends when the last participant has completed the last study visit, but can also depend on the study design (e.g. wash-out period of IMP, or safety follow up until adverse events are no longer anticipated)
Access the swissethics website for applicable and mandatory protocol templates.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
Documents
External Links
Swissethics – see in particular
- Templates / Checklists
- Study protocols
References
ICH GCP E6(R3) – see in particular guidelines
- 2.7 Participant Medical Care and Safety Reporting
- 3.13 Safety Assessment and Reporting
- Appendix B Clinical Trial Protocol and Protocol Amendment(s)
- Appendix B.9 Assessment of safety
ICH E8(R1) – see in particular guideline
- 6. Conduct, safety monitoring, and reporting
Declaration of Helsinki – see in particular principles
- 21-22 Protocol requirements
ISO 14155:2020 Medical device (access liable to cost) - see in particular sections and annex
- 6.4 Clinical Investigational Plan (CIP)
- Annex A CIP
Swiss Law
ClinO – see in particular articles
- Art. 19-20, 49, and 61 Categorisation
HRO – see in particular article
- Art. 7 Categorisation