Basic↦Documents↦Document Management↦In Studies
Was betrifft es? Warum ist das wichtig?
Studies are highly complex involving many partners and stages of operation. Study documents or records are the foundation that allow for a study to be reproduced at some later date, providing credibility to study results.
Study documents/records 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/records 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
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Was muss ich befolgen?
As a SP-INV you are responsible for the development, approval and release of all study-required documents/records 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. This ensures documents remain relevant for the required documentation of study procedures
Keep a document tracking list within each TMF/ISF folder in order to maintain overview of current and archived documents.
Keeping study documents/records up-to date ensures:
- EC / Swissmedic approved documents are implemented in the study
- Roles and responsibilities are traceable, reflecting potential shifts in study staff
Wo kann ich Hilfe anfordern?
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
External Links
Swissethics – see in particular
- Instruction for EC submission
Swissmedic – see in particular
- Guidelines for CTA dossiers submitted
FOPH – see in particular
- Submission guidelines (e.g. illegal substances or stem cell therapies)
References
ICH GCP E6(R3) – see in particular guideline and section
- II ICH GCP principles Nr. 10 Documentation of study roles and responsibilities appropriately
- 3.16.3 Record keeping and retention
- Appendix C. Essential records for the conduct of a clinical trial