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
What do I need to do?
Establish a tracking tool able to document adaptations and/or changes in study activities, such as:
- Study staff: fluctuations, introduction of novel tasks and responsibilities
- Partners: fluctuations, new partners (e.g. study sites, service providers)
- Study amendments: procedures based on study protocol, EC/RA approvals
- Safety: IB updates, adaptations in IMP/MD handling and administration
- QMS: adaptations in risk control measures, SOPs, WIs
- Finances: change in funding providers
For more information refer to Documents in this Study Guide.
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
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