What is it? Why is it important?

In studies strict document management requirements exist.


All information collected and applied in a study must be recorded, handled, and stored in a way that allows for the accurate reporting, interpretation, and verification of a study (e.g. document management in studies).


Essential documents play a key role in successful study management, and provide written evidence that the study is or was conducted in compliance with  the study protocol, ethics (EC), Swiss laws, guidelines such as GCP / ISO 14155, and the Declaration of Helsinki, and if applicable RA (e.g. Swissmedic).


A study can be audited or inspected at any time by  EC or RA. During study conduct study documents allow operational staff, monitors, auditors and inspectors to evaluate the safe conduct of the study, and the quality of the collected data.


Upon study termination, essential documents must be archived during a pre-determined number of years, as required by local laws.  

What do I need to do?

As a SP-INV and Site-INV implement a document filing system based on the following systems:

  • The TMF: Files documents and activities performed by the SP-INV and the trial site(s)
  • The ISF: Files documents and activities performed at a particular study site. Information enabling the identification of study participants is exclusively filed in the ISF, and remains at the site


Extent of documents collected and filed depends on:

  • Study type (e.g. clinical (ClinO / ClinO-MD), non-clinical (HRO))
  • Study risk-category  A higher risk category usually requires more extensive documentation
  • Mono- versus multi-centre studies
  • Study complexity (e.g. study design, numbers of participants included, study duration)


A successful document management system, whether electronic or paper-based, requires ongoing oversight and maintenance ensuring accurate and current document filing.



Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guidelines

  • 8 Essential documents for the conduct of a clinical trial
  • 4.9.4 Retention of study documents
  • 4.9.5 Document archiving
  • 5.5.6-7-8 Archiving of SP-INV documents


ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • Annex E Essential clinical investigational documents
  • 7.5 Clinical investigational documents and documentation
  • 7.8 Document and data control
  • 8.6 Document retention
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • HRO - Human Research Ordinance
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Management ↦ Document Management ↦ Requirements

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Management ↦ Document Management ↦ Requirements

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