What is it? Why is it important?
Filing of study documents is important as they:
- Individually and collectively allow for the evaluation of study conduct
- Ensure ongoing important oversight and successful study management
Essential study documents are filed by the:
- SP-INV in a Trial Master File (TMF)
- Site-INV in an Investigator Site File (ISF)
- Provide a structured filing system as depicted in ICH-GCP (Chapter 8)
- The ongoing filing of study documents during study conduct
- Allows for easy retrieval
- Are an important source used during audits or inspections by RA (e.g. Swissmedic)
Documents are filed either electronically or in paper format. For electronic paper-copies, ensure to follow certified copying procedures.
Documents that have original wet-ink signatures (e.g. ICF, various logs, CVs) are, in addition to a potential electronic copy, retained in their original form.
What do I need to do?
As a SP-INV or Site-INV file documents:
- Prior-, during- and after the completion of your study
- As applicable, in the study TMF and/or ISF
- According to ICH-GCP guidelines
- Based on restricted access (e.g. available only to study staff who needs them for the execution of given study tasks)
- In a manner that prevents accidental or premature loss or destruction
- In a timely manner in order to ensure the DMS of the study remains current
For the most part essential documents are filed both by the SP-INV in the TMF and the Site-INV in the ISF. Still, there are exceptions where documents are only filed in the ISF, as they must never be made available to the SP-INV of the study (e.g. participant identification-log).
Based on data protections laws, any information that permit the identification of study participants must exclusively remain available to the study site. Example of such documents are:
- Signed Informed Consent Forms (include participant name and date of birth)
- Subject Identification-Log (matches subject name with study ID in the study CDMS)
- Subject Enrolment Log (lists name of all participants enrolled in the study)
- Source documents that include participant identifiers (e.g. participant name, address, date of birth)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 8 Essential Documents for the Conduct of a Clinical Trial