Your Easy Guide to Clinical Studies

Studies are highly complex involving many partners and stages of operation. Study documents are the foundation that allow for a study to be reproduced at some later date, providing credibility to study results.

 

Study documents certify that:

• The study was conducted according to:
  • Local regulatory (e.g. Swissmedic) and ethics requirements (e.g. Ethics Committee)
  • The study protocol
• Participant safety and rights were protected
• data is of high quality
• IMP/IMD was correctly handled (e.g. storage, administration)

 

In studies, documents are filed in special folders:

• SP-INV documents are filed in a TMF binder
• Site-INV documents are filed in an ISF binder

 

TMF/ISF are part of the DMS needed to document, file and track study relevant activities. They shouldbe kept up to date throughout the conduct of the study

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As a SP-INV you are responsible for the development, approval and release of all study-required documents during study planning and conduct, such as:

• Study protocol
• PIS and ICF
• Contracts and insurance
• Study CRF for data recording
• Study relevant quality documents (SOPs, WIs)
• Various study logs

 

Define processes for:

• The implementation of a study DMS including its ongoing oversight and management
• Document identification (e.g. naming, version control)
• DMS training of study staff
• The incorporation of user feedback regarding implemented documents

 

Keep a document tracking list within each TMF/ISF folder in order to maintain overview of current and archived documents.

External Links

Swissethics – see in particular

• Instruction for EC submission

Swissmedic – see in particular

• Guidelines for CTA dossiers submitted

References

ICH GCP E6(R2) – see in particular guideline

• 8 Essential Documents for the Conduct of a Clinical Trial

FOPH – see in particular

• Submission guidelines (e.g. illegal substances or stem cell therapies)