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 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 the Ethics Committee (EC) and, if applicable, to Swissmedic
- If applicable, the 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 EC and, if applicable, to regulatory authorities (e.g. Swissmedic, international)
- Correspondence with EC and, if applicable, Swissmedic (e.g. subission of an Annual Safety Report, Clinical Study Report)
- 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)
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
- 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)
- Obtain ISO 14155 training certification for the use of Investigational Medical Device (IMD) (e.g. ClinO-MD studies)
- Obtain ISO 20916 training certification 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. If a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise a relevant non-medical profession
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
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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 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