Development↦Management↦Responsibilities↦Sponsor-Investigator
What is it? Why is it important?
The Sponsor-Investigator (SP-INV) carries the main responsibility for a study, such as:
- Selection of study design
- Set-up of study database
- Implementation of a risk based QMS (e.g. study monitoring, auditing, ongoing risk management)
- Process required for safety monitoring, evaluation and reporting
- Handling of IMP/MD (e.g. storage specifications)
- Submission to EC and applicable regulatory authorities
- Financial guarantee from concept until study completion
- Applicable study insurance
- Set-up of partner contracts
- Clinical Study Report
- Registration in a primary registry recognised by WHO or clinicaltrials.gov
- Publication of all research related work
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A SP-INV is an individual that carries both SP and INV obligations and responsibilities.
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/MD 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:
- Be familiar with legal requirements for the SP-INV
- Have GCP training for IMP studies (note: additional GCP courses are required for SP-INVs)
- Have ISO 14155 training for MD studies
- Exercise the applicable medical profession and have the required professional knowledge and scientific expertise
- Exercise the applicable type of research according ClinO (e.g. investigational medicinal product versus medical device versus transplantation versus other clinical studies according to ClinO)
- If no medical profession is needed and if applicable, exercise another profession (non-medical) for ClinO chapter 4 studies or studies performed under the HRO ordinance (e.g. research or further use of data involving measures for sampling of biological material or collection of health-related personal data)
Depending whether you are a SP-INV or Site-INV will highly affect types of obligations and responsibilities.
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Write-up, define, and implement 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/MD, laboratory, CRF completion guideline)
- Applicable processes (e.g. safety reporting)
- Submission to EC and RA
Defining these processes may need the input of different specialists.
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