Your Easy Guide to Clinical Studies

Apart from the study protocol, other study and reference documents provide study relevant safety information, such as the:

 

• Participant Information Sheet (PIS) / Informed Consent Form (ICF): explains expected study benefits and risks to study participants
• Case Report Form (CRF) / Study Database: where (serious) Adverse Events (AE) (e.g. AEs in investigational Medicinal Product (IMP) studies,  AEs / Device Effects in Investigational Medical Device (IMD) studies) are documented in a standardised manner
• Product Information (PI): summarises all currently known safety information on marketed Medicinal Products
• Instruction for use (IFU): summarises all currently known safety information on marketed Medical Devices
• Investigator Brochure (IB): summarises all currently known safety information on non-marketed products (e.g. IMP, IMD)
• Monitoring plan: describes the risk-based monitoring strategy of the study (e.g. high risk studies require more extensive monitoring)

As a SP-INV ensure safety information are describd in applicable study documents, such as:

• Study Protocol
• PIS / ICF: include a list of foreseeable frequent AEs sorted by frequency. For infrequent ones include only serious ones
• Safety Management Plan: describes the strategy on how do identify, assess, control, and manage safety issues during study conduct (e.g. risk assessment form)
• Monitoring plan: adapt your monitoring strategy based on the risk assessment of your study (e.g. high risk requires more frequent monitoring visits)
• The study CRF: Irrespective whether in electronic or paper form (e.g. questionnaires), include sections for the documentation of safety events (e.g. IMP safety reporting, IMD safety reporting). Define whether SAE forms are available in electronic or paper form

 

Based on your study, describe the reference documents that apply to your study (e.g. Investigator`s Brochure (IB) for IMP/IMD, SmPC / PI for marketed MP, IFU for marketed MDs).

More

Documents

• Monitoring Plan Template
• Guidelines for Risk-Based monitoring in Clinical Trials
• Position paper: Monitoring in Non-Interventional Human Research Projects

External Links

Swissethics – see in particular

• Templates / Checklists
  • Study protocols
  • Patient information and consent

References

ICH GCP E6(R3) – see in particular guidelines

• 2.7 Participant Medical Care and Safety Reporting
• 3.11.4.3 Monitoring plan
• 3.13 Safety Assessment and Reporting
• Appendix B Clinical Trial Protocol and Protocol Amendment(s)
• Appendix B.9 Assessment of safety

ICH E8(R1) – see in particular guideline

• 6. Conduct, safety monitoring, and reporting