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

References

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

Swiss Law

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • ED – Essential Documents
  • HRO – Human Research Ordinance
  • ICF – Inform Consent Form
  • ICH-GCP – International Council for Harmonisation – Good Clinical Practice
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Basic ↦ Documents ↦ Essential Documents ↦ Requirement
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Documents ↦ Essential Documents ↦ Requirement

Please note: the Easy-GCS tool is currently under construction.