What is it? Why is it important?
Essential Documents are all those documents which individually and collectively permit the full reconstruction of the study by evaluating:
- The validity of a study
- The integrity and quality of the data
- Factors affecting the study and actions taken
- The compliance by Site-INV, SP-INV and monitor with the study protocol, GCP and applicable regulatory requirements.
In order to allow for the above criteria, all essential documents generated during study conduct need to be retained and filed on an ongoing basis.
NOTE: “What has not been documented is considered not done!
- Are filed in the ISF by the Site-INV and in the TMF by the SP-INV
- Are filed in a timely manner starting at the beginning of a study until study closure by both Site-INV and SP-INV
- Are archived over a predefined period of time after study completion
- Are reviewed by the monitor during the monitoring of the study
- Are reviewed by RA during an inspection.
What do I need to do?
File all essential documents generated during study conduct in applicable files (TMF and/or ISF), which includes amongst others the:
- Investigator’s brochure and updates thereof
- The study protocol, PIS, ICF, and amendments thereof
- EC/RA approval(s), updates and communication
- Ongoing staff qualification and training records
- Laboratory maintenance, certification of analysis
- IMP/MD and material management
- Monitoring visits performed during study conduct, including applicable audits or inspections
- Communication between Site-INV and SP-INV, and other relevant partners
- Annual safety reports
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, 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
- 8.0 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