What is it? Why is it important?
Essential Documents (ED) are study relevant documents collected prior-, during- and after study completion.
Based on ED:
- Study set-up, implementation and conduct can be retraced from start to finish
- Quality of collected study data can be evaluated
- Compliance of the SP-INV/Site-INV with the study protocol, ICH-GCP and regulatory requirements can be assessed by:
- Monitors during monitoring visits
- Auditors during SP-INV audits
- Inspectors during Swissmedic inspections
Extent of ED that must be collected and filed depends on study type (e.g. ClinO, ClinO-MD, HRO) and study risk category (e.g. A, B, C).
Apart from ED listed ICH-GCP (chapter 8), additional quality documents such as SOPs, checklists, processes, and WIs are needed for the faultless running of a study.
What do I need to do?
As a SP-INV or Site-INV:
- Know the ICH-GCP requirements regarding ED (Chapter 8 lists documents to be collected before-, during-, and after study completion)
- Ensure EDs are kept current. Start filing during study planning ending with study completion
- Record and file EDs in a way that allows the study to be accurately reported and verified
- Keep EDs access restricted, but make them accessible to study staff, monitors and inspectors
- Include ED-identifiers in order to track document changes and updates
- Archive EDs upon study termination
In order to maintain ongoing ED management and oversight, file EDs in the:
- Trial Master File (TMF) for SP-INV relevant documents
- Investigator Site File (ISF) for site relevant document, including site specific generated documents (e.g. signed-ICFs, Participant-Identification-Log)
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 guidelines
- 1.23 Essential Documents definition
- 5.18.4p Monitor’s Responsibilities
- 8 Essential Documents for the Conduct of a Clinical trial
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- Annex E Essential clinical investigation documents
ClinO – see in particular article
- Art. 19 Categorisation of clinical trials
ClinO-MD – see in particular
- Art. 6 Categorisation of clinical trials
HRO – see in particular article
- Art. 7 Categorisation