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 other participating study sites in the event of a multicentre study.
Responsibilities include:
- Selection of a study design
- Study feasibility and selection of participating study sites (e.g. feasibility questionnaire)
- Definition of the the study`s research question, study outcome / endpoint. and define the Statistical Analysis Plan
- Set-up the study database and ensure ongoing data security and protection
- Implementation of a risk based QMS,(e.g. risk-based monitoring, study-site or partner auditing, and ongoing risk management)
- Definition of the study`s safety assessment, reporting. and review procedures, including the submission of an Annual Safety Report to the Ethics Committee (EC) and, if applicable, to Swissmedic
- Management of:
- 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
- Study insurance
- Set-up of partner contracts
- Submission to and correspondence with (e.g. Clinical Study Report) EC and, if applicable, regulatory authorities (e.g. Swissmedic, international)
- Study Registration
- Publication and dissemination of study results
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The SP-INV:
- Initiates and conducts, alone or with others, a clinical study
- Retains ongoing study oversight from start to finish, including the archiving of study documents
- Manages the distribution of the IMP/IMD to the study sites (to Site-INV)
A SP-INV must exercise an applicable medical profession and have the professional knowledge and scientific expertise required for the planned study. If a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise a relevant non-medical profession
This term SP-INV specifically refers to an individual and excludes entities such as corporations or agencies.
What do I need to do?
As a SP-INV:
- Familiarize yourself with SP-INV responsibilities
- Ensure to have the required professional trainings for study conduct, such as to have and/or guarantee the required:
- Qualification, knowledge, and experience
- Knowledge and skills in the areas of data security and data protection
- Legal knowledge for governing studies
- Retain ongoing oversight of study activities, including delegated tasks
- Attend GCP training courses on the use of Investigational Medicinal Products (IMP) (e.g. ClinO studies)
As a SP-INV you carry both:
- Sponsor responsibilities: overall responsibility for a study, which in a multi-centre study includes all participating study sites
- Investigator responsibilities: represents the responsibility for a particular study site. A site responsible investigator is named the Site-INV
Depending on whether you are the SP-INV of a study or solely the Site-INV, will greatly affect study obligations and responsibilities.
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Based on your planned study, as a SP-INV you must also comply with:
- The Swiss Law and its Ordinances (e.g. the HRA act, the data protection act, ClinO, ClinO-MD)
- 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)
- ISO 14155 for studies with Investigational Medical Device (IMD) (e.g. ClinO-MD studies)
- ISO 20916 for studies with in vitro medical device studies
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 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 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
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 articles
- Art. 2d Definition sponsor
- Art. 6 Professional qualifications
ClinO-MD – see in particular articles
- Art. 2d Definition of sponsor
- Art. 5 Professional qualifications
HRO – see in particular article
- Art. 4 Professional qualifications