Conduct↦Management↦Responsibility and Oversight↦Sponsor and Site-Investigator
What is it? Why is it important?
During study conduct, both SP-INV and Site-INV are responsible to maintain study oversight with the aim to ensure that:
- The study is implemented in compliance with:
- The approved study protocol
- Ethics Committee (EC), and if applicable RA (e.g. Swissmedic, FOPH) requirements
- Applicable laws (e.g. Swiss laws, international)
- Applicable guidelines (e.g. ICH-GCP for ClinO studies, ISO 14155 for ClinO-MD studies, ISO 209106 for IVD studies)
- Study relevant SOPs and WIs (e.g. informed consent process)
- Study staff is trained on delegated tasks
- Tasks are correctly executed (e.g. based on a site delegation-log)
- Participants rights and safety are protected (e.g. data confidentiality, ongoing safety reporting)
- The integrity and quality of study data is guaranteed (e.g. data quality and assurance)
- A risk-based Quality Management System (QMS) is in place, and risk control-measures remain effective and relevant
- The study retains ongoing financial coverage (e.g. study budget)
A SP-INV and Site-INV can delegate study tasks, however overall responsibility remains with them.
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The study budget represents the total sum of money needed to guarantee for the successful set-up, conduct and completion of a study.
Circumstances that might jeopardize and increase study costs during study conduct are unforeseen events such as:
- Protocol amendments
- Inclusion of additional study sites due to poor recruitment at existing study sites
- Slow recruitment rate with an extended period needed for study conduct, coupled with grant providers with a restricted funding period (e.g. only for 2 years)
- Staff fluctuations and additional staff requirements resulting in addtional costs and trainings
What do I need to do?
At Site-INV level, oversight tasks during study conduct include to:
- Ensure ongoing recruitment of study participants proceeds according to timeline
- Manage shifts and reassessments of staff responsibilities (e.g. site delegation-log)
- Ensure ongoing staff trainings (e.g. SOPs, WIs and processes)
- Ensure risk control-measures remain effective and relevant
- Comply with safety reporting responsibilities
- Ensure the correct handling of the investigational product (e.g. IMP/IMD storage and accountability)
- Ensure the correct handling of Biological Material (BM)
- Comply with document management requirements (e.g. in studies)
At SP-INV level, oversight tasks during study conduct include to:
- Perform routine monitoring visits based on a monitoring plan
- Ensure compliance with the study`s risk-based QMS (e.g. risk review, audit)
- Provide the site (as applicable) with additional SOPs, essential documents, IMP/IMD, and other material needed for study conduct
- Follow-up on safety reporting requirements (e.g responsibilities)
- Follow-up on data entry and data quality requirements
- Monitor study budget and obtain additional funding to offset unforeseen costs ahead of time
As a SP-INV and Site-INV, ensure ongoing study oversight by planning and documenting regular staff meetings.
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During staff meetings, pending issues and problems are addressed, which ensure the protection of study participants and the quality of study data. In addition, measures are implemented early on avoiding unnecessary delays during study conduct.
Document meetings and decisions taken in an applicable meeting protocol. The meeting protocol provides:
- Resolution of pending issues
- Transparency and reference tool for absentees
- Evidence of study oversight in the event of an inspection by RA (e.g. Swissmedic)
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 4.2.5 Supervision of delegated tasks
- 4.2.6 Qualification of delegated tasks
- 4.5 Protocol compliance
- 4.11 Safety reporting
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 10 Responsibilities of the principle investigator
Swiss Law
ClinO – see in particular article
- Art. 5 Rules of good clinical practice