Set-Up↦Documents↦Required Documents↦Master and Site File
What is it? Why is it important?
The Trial Master File (TMF) and the Investigator Site File (ISF) are repositories used to file study documents (e.g. essential-, quality documents).
As a document repository:
- SP-INV documents are filed in the TMF, while site documents are filed by the SIte-INV in the ISF
- Documents are filed both prior, during and after study completion
- Filing can either include hardcopies, electronic copies, original documents or a mix
- A TMF/ISF index system greatly facilities the document management of the study
- The TMF/ISF are important resources during audits and inspections
TMF/ISF files are important documents that bear witness to the conduct of the study. They confirm the study’s compliance with the study protocol, ICH-GCP, including regulatory requirements. Incomplete filing bears the risk of non-compliance, jeopardising participant safety and the quality of study data.
The ISF binder is checked during:
- Study monitoring both at the beginning, during and after the completion of the study
- SP-INV audits
Both TMF and ISF binders are checked during
- Regulatory inspection (e.g. Swissmedic)
Upon study completion TMF/ISF folders must be archived for a required number of years (e.g. based on legal requirements or specifications in the study protocol). This will allow applicable authorities to re-visit the study should that become necessary.
What do I need to do?
As a SP-INV of a planned study:
- Establish and start to file study relevent documents in the TMF already while planning your study
- Include a binder directory
- In a multicentre study, set-up and provide each study site with an ISF
- During monitoring check TMF and ISF folders at study site(s) to ensure that document filing is complete and current
As a SP-INV and Site -INV
- Keep TMF/ISF binders in a place only accessible to study staff
- Update both TMF/ISF whenever applicable documents become available
- Ensure that an essential document-tracking list is set-up and up to date
- The SP-INV and Site-INV are responsible to maintain a record stating the location(s) of all essential study documents
- Irrespective of media used, the storage system:
- Should allow for the correct document identification, location and retrieval
- Must ensure that documents are protected against accidental disclosure, change or deletion
- The set-up of a study relevant DMS is here the key
- Once the study is terminated archiving procedures must ensure that documents remain readable during the entire archiving period
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
ICH GCP E6(R2) – see in particular guidelines
- 4.9 Records and Reports
- 5.5 Record Keeping
- 8 Essential Documents for the Conduct of a Clinical Trial