What is it? Why is it important?
Study Management is the backbone of successful study implementation and outcome.
In other words:
The ability to plan, organise, coordinate, control activities and get things done with and through other people in order to achieve overall objective(s).
For studies this would mean to ensure:
- The safety and rights of study participants
- The quality of collected data necessary for study evaluation
Study management must operate within an ethics framework (e.g. Ethics Committee, Declaration of Helsinki, Declaration of Taipei), regulatory requirements (e.g. Swissmedic, Federal Office of Public Health, international), and applicable guidelines (e.g. ICH-GCP, ISO 14155, ISO 20916)
What do I need to do?
The successful management of a study requires:
- Adequate disposable free time for the ongoing management of the study
- Access to experienced supporting study staff (e.g. expert physician, study nurse, project manager, monitor, statistician, data manager)
- Access to professional supporting partners (e.g. field experts, additional study sites, laboratories, various service providers)
- Access to adequate financial resources to realise the study
When planning a study, various fields of expertise are required, such as:
- Specialist physician in the role as SP-INV
- Site-INV responsible for a study site
- Study nurse
- Study coordinator
- Project manager
- Data manager
- Quality manager or auditor
- Regulatory manager
- Laboratory manager
Depending on study type (e.g. ClinO, ClinO-MD, HRO, Other Clinical Studies) and activities involved, other players might also be important, such as biobanking experts, lawyers, patient organisations, cohort managers, etc.
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
Swissethics – see in particular
- Information on further education
- Staff List
ICH GCP E6(R2) – see in particular guideline
- 2.0 Principles of ICH GCP
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- 4 Summary of GCP principles
- 68 Clinical investigation planning, conduct and termination
SAMW – see in handbook
- Research with human subjects