What is it? Why is it important?
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:
- 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:
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
What do I need to do?
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.
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
Swissethics – see in particular
- Instruction for EC submission
Swissmedic – see in particular
- Guidelines for CTA dossiers submitted
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)