Conduct↦Safety↦Safety Reporting↦Responsibilities
What is it? Why is it important?
Main aim and concern for anyone conducting a study is to guarantee the safety and rights of study participants as well as the quality of the study data.
In order to fulfil safety management responsibilities, the SP-INV, Site-INV, and Project Leader (PL)of non-interventional research projects must:
- Implement a risk-based QMS with the aim to identify study risks (e.g. Critical to Quality factors) and define risk-control measures
- Provide study staff with safety management SOPs, WIs, and applicable training
- Allocate safety responsibilities in compliance with legal obligations and according to contractual agreement(s)
- Based on study risk-category and complexity inlcude a Data Safety Monitoring Board (DSMB)
- Ensure safety reporting procedures are complied with during study conduct
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Ethics Committee (EC) and Regulatory Authorities (RA) (e.g. Swissmedic, FOPH) responsibilities:
In the event of safety concerns:
- The EC may request safety information and/or documentation from the SP-INV and/or Site-INV, or PL . Decide to revoke or suspend study / project authorisation, or make its continuation subject to additional conditions
- Regulatory retain the right to initiate applicable measures (e.g. study / site inspections)
The EC and RA keep each other informed and coordinate their measures.
What do I need to do?
- Know and implement safety reporting laws and guidelines:
- The Human Research Ordinance (HRA)
- HRO for non-interventional research projects
- ICH GCP for Medicinal Product studies
- ISO 14155 for Medical Device studies
- Delegate safety responsibilities to safety trained staff (e.g. delegation-log)
- Assess safety events (see overview safety terminology) and evaluate if they require expedited reporting (e.g. within required hours or days)
- Maintain oversight on current and new safety concerns regarding the product under investigation (e.g. according to the safety management plan, IB updates)
- Implement risk reviews and assess applicability and efficacy of risk control-measures
- Implement applicable safety reporting procedures
- Ensure appropriate medical care to participant experiencing safety event(s)
As a SP-INV, PL:
- Ensure risk-based safety SOPs and/or WIs remain current
- Inform Site-INVs or participating project sites of new safety concerns (multi-centre studies)
- Evaluate necessary steps in the event of an unfavourable shift in the study/project risk-benefit ratio (e.g. a protocol / CIP amendment, premature study termination)
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Regardless of reporting deadlines, the Site-INV, SP-INV, and PL must first attend to participant safety and well-being.
AEs (both serious and non-serious) are followed until resolution or stabilisation of the event. Participants with ongoing AEs at study termination (including follow-up visits) are followed further up until recovery or stabilisation of the event.
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
Documents
External Links
Swissethics - see in particular
Swissmedic – see in particular information sheets
- Safety Notification
- BW101_10_002e_MB FAQ on clinical trials with medicinal products
- MU680_20_004e_MB Medical devices FAQs Patients
References
ICH GCP E6(R3 – see in particular guidelines
- 4.11 Safety reporting
- 5.16 Safety Information
- 5.17 Adverse Drug Reaction Reporting
- 7.1 Invetigator`s Brochure
ICH E8(R1) – see in particular
- 6.2 Participant safety during study conduct
ICH E2A Definition and standards for expedited reporting
ISO 14155:2020 Medical device (access liable to cost) – see in particular sections and annex
- 9.2.5 Safety evaluation and reporting (SP-INV)
- 10.8 Safety reporting (site-INV)
- Annex G EC responsibilities
Swiss Law
HRA – see in particular articles
- Art. 15 Safety and protective measures
- Art. 48 Official measures
ClinO – see in particular articles
- Art. 37 Notification of safety and protective measures
- Art. 39 Documentation of AE
- Art. 40 Documentation and reporting of SAE
- Art. 41 Documentation and reporting of SUSAR
- Art. 42 Documentation and reporting of SAE for in vitro MD
- Art. 43 ASR
- Art. 44 Reporting on the use of radiation sources
ClinO-MD – see in particular articles
- Art. 32 Documentation of AE
- Art. 33 Reporting of SAE
- Art. 34 reporting of safety and protective measures
- Art. 35 ASR
- Art. 39 Reporting on the use of radiation sources
HRO – see in particular articles
- Art. 3 Responsibilities of project leader and sponsor
- Art. 21 SE definition and reporting