Set-Up↦Documents↦Required Documents↦Study Initiation
What is it? Why is it important?
At the Site Initiation Visit (SIV) the monitor prepares the site for study start. As the correct handling of study documents is essential for the documentation of study conduct, an important aim is to train study staff on document management.
Study documents that are handled during study conduct include:
- The study protocol
- The PIS and ICF
- Various logs such as the delegation, training, screening, inclusion, identification, monitoring visit, drug accountability, sampling, temperature
- Guidelines for IMP/IMD handling: pharmacy manual, shipment documents
- Safety documents: safety reporting, IB, product information (e.g. IMP) / instruction for use (IMD)
- EC and RA (e.g. Swissmedic) approval certificates
- The study CRF, in paper and/or electronic form
- Source documents (SD)
- Quality documents: SOP, WIs, checklists
- Study management documents: insurance, contracts, communication
- Advertisement, patient compensation, worksheets, questionnaires
What do I need to do?
As a SP-INV and Site-INV define and delegate document management responsibilities to a qualified staff member.
Document management responsibilities to ensure that:
- The ongoing oversight of study documents is guaranteed (e.g. draft-, currently active- versus archived documents)
- Essential documents are filed in a current and complete manner both in the TMF and/or ISF
- Only current and EC/RA approved documents remain in circulation and consequently used in the study (e.g. ICF, PIS, study protocol)
- Study logs are complete and kept current
- Study documents are locked away and access protected, but made available to study staff who need them for the execution of their study tasks
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