Development↦Management↦Study Management↦Tracking
What is it? Why is it important?
A study can last for many years. Tracking is an effective tool used to monitor study progress and might include:
- Adherence to study milestones:
- 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
What do I need to do?
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
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
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