What is it? Why is it important?
Essential Documents (ED) are documents collected prior-, during- and after study completion in order to demonstrate study staff compliance with the study protocol, GCP, and applicable regulatory requirements.
Based on essential documents:
- Study set-up and implementation can be retraced from start to finish
- Quality of study data can be evaluated
- Protocol compliance can be assessed
- Are reviewed during study monitoring, SP-INV audit, or during regulatory inspection
- Should only be accessible to study staff, study monitor, and if applicable auditors and inspectors
In order to track currency and revision of study documents, unique identifier should be given, such as:
- Appropriate name related to its use
- Date when the document was issued
- Version number based on minor or major changes (e.g. 1.0, 1.1, 1.2, 2.0, 2.1)
- Relevant author(s)
- If applicable, staff that reviewed, approved, and released the document (e.g. study protocol, monitoring plan, study specific SOPs)
What do I need to do?
Based on the planned study, various essential documents must be generated and filed. ICH-GCP section 8 and ISO 14155, Annex E give a non-exhaustive overview of essential documents before-, during-, and after study completion.
Essential documents are filed in a:
- Trial Master File (TMF): SP-INV documents
- Investigator Site File (ISF): documents generated and filed at a particular study site
Essential documents can also include various check-lists, process-, SOPs and WIs needed for the faultless running of the study.
For more information refer to Documents in this Study Guide.
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
- 1.23 Essential documents definition
- 5.18.4p Monitoring responsibilities
- 8.1-4 Filing of essential documents
ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections
- Annex E Essential clinical investigation documents