Development↦Management↦Responsibilities↦Sponsor-Investigator
What is it? Why is it important?
A Sponsor-Investigator (SP-INV) carries the main responsibility for a study, including potential participating study sites in a multicentre study.
Responsibilities include the:
- Selection of a relevant study design
- Study feasibility and the selection of participating study sites (e.g. feasibility questionnaire)
- Set-up of the study database
- Implementation of a risk based QMS,(e.g. risk-based monitoring, study-site or partner auditing, and ongoing risk management)
- Definition of safety assessment, reporting. and review procedures, including the submission of an Annual Safety Report to Ethics Committee (EC) and if applicable Swissmedic
- As applicable, the handling of study:
- IMP/IMD (e.g. distribution, storage, and administration specifications)
- Biological Material (e.g. handling of BM)
- Financial guarantee from study concept until completion, including archiving
- Provision of applicable study insurance
- Set-up of partner contracts
- Submission for study approval by EC and if applicable regulatory authorities (e.g. Swissmedic, international)
- Subission of a Clinical Study Report to EC and as applicable Swissmedic
- Registration of the study
- Publication of research results
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The SP-INV both:
- Initiates and conducts, alone or with others, a clinical study
- Retains ongoing study oversight from start to finish, including the archiving of study documents
- Directs to whom the IMP/IMD is administered and dispensed (to Site-INV)
The term does not include any person other than an individual. It does not include a corporation or an agency.
What do I need to do?
As a SP-INV:
- Familiarize yourself with SP-INV responsibilities
- Retain ongoing oversight regarding study activities including its delegated tasks
- Attend GCP training courses for the use of Investigational Medicinal Products (IMP) (e.g. ClinO studies)
- Have ISO 14155 training for the use of Investigational Medical Device (IMD) (e.g. ClinO-MD studies)
- Have ISO 20916 training for the use of in vitro medical device studies
- Exercise an applicable medical profession and have the professional knowledge and scientific expertise required for the planned study. In the event a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise a study applicable non-medical profession
As a SP-INV you carry both:
- Sponsor responsibilities: with the main and overall responsibility for a study, which in a multi-centre study includes the responsibilities over several participating study sites
- Investigator responsibilities: represents the responsibility for a particular study site. A site responsible investigator is named the Site-INV
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Depending on whether you are the SP-INV of a study or solely the Site-INV, will greatly affect study obligations and responsibilities.
Based on your planned study, as a SP-INV you must also comply with:
- The Declaration of Helsinki
- The Declaration of Taipei for the management of a biobank
- Ethics requirements set forth by EC
- Regulatory authorities (e.g. Swissmedic, FOPH, international)
- The Swiss Law and its Ordinances (e.g. ClinO, ClinO-MD)
As a SP-INV, write-up, define, and implement among others the following study documents and processes:
- Study protocol
- Content of Trial Master File (TMF)
- Study essential documents (e.g. study forms, logs, checklists etc.)
- Participant information and consent
- Statistical plan
- Data management plan
- Risk based monitoring plan
- Risk based quality management system
- Study contracts
- Study insurance
- Study manuals (e.g. IMP/IMD, laboratory, CRF completion guideline)
- Applicable processes (e.g. safety reporting)
- Submission documents to EC and RA
These processes may need the input and support from various experts (e.g. data manager, statistician, project and safety manager, monitor, regulatory expert, study nurse)
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
External Links
Swissethics – see in particular
- Information on professional qualifications
- List of persons conducting a study
References
ICH GCP E6(R2) – see in particular guidelines
- 1.53 SP-INV definition
- 5 SP-INV responsibilities
- 8 Essential study documents
ISO 14155:2020 Medical Devices - see in particular sections (access liable to costs)
- 3.49 Sponsor definition (SP-INV)
- 9 Responsibilities of the sponsor (SP-INV)
Swiss Law
ClinO – see in particular article
- Art. 6 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications