Conduct↦Management↦Responsibility and Oversight↦Sponsor and Site-Investigator
Was betrifft es? Warum ist das wichtig?
A SP-INV and Site-INV are responsible to maintain ongoing study oversight, from study planning until completion.
The aim is to ensure that:
- The study is implemented in compliance with:
- The Ethics Committee (EC) and, if applicable, Swissmedic FOPH approved study protocol
- Applicable laws (e.g. Swiss laws, international)
- Principles of ethics and applicable guidelines (e.g. ICH-GCP, ISO 14155 , ISO 209106)
- 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
- Outsourced services provided by relevant partners are of high quality (e.g. statistic, data management, laboratory)
- The study retains ongoing financial coverage (e.g. study budget)
A SP-INV / Site-INV can delegate study tasks to study staff and partners (e.g. service providers). However responsibility cannot be delegated but remains under their charge.
Mehr
The study budget represents the total sum of money needed to guarantee for the successful set-up, conduct and completion of a study.
The SP-INV of the study is responsible to ensure the ongoing funding to the study. If needed, the SP-INV is responsible to obtain additional funding to offset unforeseen costs.
Circumstances that might 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
Was muss ich befolgen?
During study conduct:
At Site-INV level, oversight tasks include to:
- Ensure participant recruitment according to timeline
- Manage shifts and reassessments of staff responsibilities (e.g. site delegation-log)
- Ensure current 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 (IMP / IMD) (e.g. storage, access protected, product accountability)
- Ensure the correct handling of Biological Material (BM)
- Comply with document management requirements (e.g. in studies)
At SP-INV level, oversight tasks include to:
- Perform monitoring visits, based on a monitoring plan, to ensure data quality and protections of study participants (e.g. risk-benefit ratio)
- Ensure compliance with the study`s risk-based QMS (e.g. risk review, auditing of outsourced partner services)
- 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)
- Monitor study budget and obtain additional funding to offset unforeseen costs ahead of time
Mehr
As a SP-INV and Site-INV, ensure ongoing study oversight by planning and documenting regular staff meetings.
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 / findings
- Transparency and reference tool for absentees
- Evidence of study oversight in the event of an inspection by RA (e.g. Swissmedic)
Wo kann ich Hilfe anfordern?
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(R3) – see in particular guidelines
- 2.3 Responsibilities – Investigator
- 2.3.1 Supervision of delegated tasks
- 2.3.2 Qualification of delegated tasks
- 2.5 Protocol compliance
- 2.7 Participant Medical Care and Safety Reporting
- 3.4 Qualifications and Training - Sponsor
- 3.9 Sponsor Oversight
- 3.12 Noncompliance
ICH GCP E6(R3) – Annex 2 – see in particular articles
- 2.4 Investigator Oversight
- 3.8 Sponsor Oversight
ICH E8(R1) – see in particular article
- 2.1 Protection of Clinical Study Participants
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 and annex
- Art. 5 Rules of Good Clinical Practice
- Annex 1, number 2 Rules of Good Clinical Practice