Your Easy Guide to Clinical Studies

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

• Adherence to study milestones:
  • Participant recruitment within timelines as defined by the study protocol
  • Ongoing data entry with queries or findings including their resolution during study monitoring
• 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

 

Apart from study tracking, changes in the law (e.g. Swiss law) or applicable guidelines (e.g. ICH GCP, ISO 14155) require tracking and ensuing adaptations. These changes can have a significant impact on how to conduct a study (e.g. adaptations regarding the data protection act, SP-INV and Site-INV expected responsibilities)

As a SP-INV and Site-INV, implement as part of study oversight responsibilities, a tracking system with the aim to track adaptations and/or changes to study activities.

 

Tracking may include aspects such as: 

• Study documentation: study documents are identifiable, up to date, and correctly filed 
• Study staff: fluctuations, introduction of novel tasks and responsibilities (e.g. delegation log)
• Partners: fluctuations, new partners (e.g. study sites, service providers)
• Study amendments: changes and validity of essential documents (e.g. protocol-, ICF amendments), with consequential submission to the Ethics Committee (EC), and if applicable, to Swissmedic for approval
• Safety: IB updates, adaptations in the handling of the investigational therapeutic product (IMP / IMD)
• QMS: adaptations in risk-control measures, SOPs, WIs
• Finances: change in funding providers

 

An efficient tracking system is the implementation of study team meetings. During joint meetings, the current status of the study can be discussed, and potential risk-control-measures can be assessed and implemented.

 

External Links

Swissethics – see in particular

• Template: Staff List

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: Definitions of Investigator’s brochure, Protocol and Protocol amendment
• 2.3 Site-INV responsibilities
• 3. SP-INV responsibilities
• 3.5 Financing
• 3.9 Sponsor Oversight
• 3.10 Quality Management
• 3.11 Quality Assurance and Quality Control
• Appendix A. Investigator’s brochure
• Appendix B. Clinical trial protocol and amendment(s)

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