Your Easy Guide to Clinical Studies

The safety management plan address procedures needed for the ongoing safety evaluation of a study. The aim is to guarantee the timely capturing, accurate assessment, documentation and management of safety events.

 

The plan includes procedures on how to:

• Define safety collection timeframe – safety collection start / stop
• Assess safety events – safety assessment procedures
• Report safety events – safety reporting procedures
• Delegate safety tasks – safety responsibilities
• Define and manage safety protective measures
• Manage blinding/un-blinding procedures in blinded studies (e.g. where the allocation of an intervention is unknown to participants and  also researchers)
• Act upon a shift in the study’s risk-benefit ratio

 

For the ongoing risk-benefit assessment during study conduct, access to newly observed and documented safety information is crucial (e.g. IB updates for IMP/IMD, doctor’s letter, pharmacovigilance).

As a SP-INV:

• Create safety forms (e.g. safety questionnaires) and guidelines (e.g. SOPs, WIs) that describe SAE reporting procedures. Include reporting procedures for pregnancy and other safety issues
• Build and maintain a safety database (e.g. eCRF, pCRF) for the collection of safety information (e.g. based on protocol requirements)
• Define and delegate safety tasks and responsibilities in writing (e.g. contracts and agreements, site-delegation-log)
• Set-up study procedures that describe how to centralise and manage safety events:
  • Triage of all safety events notified by the Site-INV (e.g. check for data accuracy and completeness)
  • Assignment of case numbers (e.g. SAE numbering)
  • Communication with site(s) to obtain required documents needed for the resolution of inconsistencies and the completeness of data
  • Expedited safety reports and annual safety reporting to EC/RA (e.g. Swissmedic)
  • Exchange of information with Site-INV regarding safety issues

More

External Links

Swissethics – see in particular

• Templates and checklists / Notifications
  • SAE medicinal products
  • SAE medical devices
  • Annual Safety Report

Swissmedic – see in particular

• Human medicine
  • Clinical trials on medicinal products
  • Safety measures in clinical trials
• Medical devices
  • Clinical trials
  • Submissions during ongoing clinical trials

References

ICH GCP E6(R2) – see in particular guideline

• 4.11 Safety reporting
• 5.16 Safety Information
• 6.8 Assessment of Safety

 

ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

• 9.2.5 Safety evaluation and reporting
• 10.8 Safety reporting

 

MDCG 2020 – see in particular guideline

• 5 Reportable Events

Swiss Law

HRA – see in particular article

• Art. 15 Safety and protective measures

ClinO – see in particular article

• 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. 43 Annual safety report
• Art. 63 Documentation and notification of SAE

ClinO-MD – see in particular article

• Art. 32 Documentation of AE
• Art. 33 Reporting of SAE
• Art. 34 Reporting of safety and protective measures
• Art. 35 Annual Safety Report

HRO – see in particular article

• Art. 21 SE definition and reporting

Documents

• Safety Expert Finder
• Safety Reporting Forms for Clinical Research Projects
• Online Safety Training