Your Easy Guide to Clinical Studies

A study can last for many years. Tracking is an effective tool used to monitor study progress and might include:

• Adherence to study milestones:
  • Participant recruitment within timelines as defined by the study protocol
  • Ongoing data entry including query resolution
• Partners: service providers and the recruitment of additional study sites
• Amendments: changes to study protocol or design, including amended study documents (e.g. study protocol, ICF, CRF)
• QMS: risk assessment, monitoring
• Finances

As a SP-INV and Site-INV, establish a tracking tool able to track adaptations and/or changes in study activities including study documents, such as:

• Study staff: fluctuations, introduction of novel tasks and responsibilities
• Partners: fluctuations, new partners (e.g. study sites, service providers)
• Study amendments: changes and validity of essential documents (e.g. study protocol, ICF)
• Study approval(s): submission to the Ethics Committee (EC) and Swissmedic 
• Safety: IB updates, adaptations in IMP/IMD handling and administration
• QMS: adaptations in risk-control measures, SOPs, WIs
• Finances: change in funding providers

 

References

ICH GCP E6(R2) – see in particular guidelines

• 1.44 Protocol definition
• 6. Clinical trial protocol and protocol amendment(s)
• 7. Investigators brochure

ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

• 6.4 Clinical investigation plan
• 6.5 Investigators brochure
• 7.5.1 Amendments