What is it? Why is it important?

Studies are highly complex involving many partners and stages of operation. Study documents are the foundation that allow for a study to be reproduced at some later date, providing credibility to study results.

Study documents certify that:

  • The study was conducted according to:
    • Local regulatory and ethical requirements
    • The study protocol
  • Participant safety and rights were protected
  • data is of high quality
  • IMP/IMD was correctly handled (e.g. storage, administration)

In studies, documents are filed in special folders:

  • SP-INV documents are filed in a TMF binder
  • Site-INV documents are filed in an ISF binder

TMF/ISF are part of the DMS needed to document, file and track:

  • Study relevant activities
  • Documents provided by SP-INV/Site-INV including collaborating partners (e.g. essential documents, EC/RA approvals, communication and contract(s), safety information, lab-manuals).

More

Some key study documents need initial EC and/or RA approval prior to being implemented (e.g. study protocol, PIS, ICF, CRF, questionnaires or other material handed out to participants, IB, contracts)

What do I need to do?

As a SP-INV you are responsible for the development, approval and release of all study-required documents during study planning and conduct, such as:

  • Study protocol
  • PIS and ICF
  • Contracts and insurance
  • Study CRF for data recording
  • Study relevant quality documents (SOPs, WIs)
  • Various study logs

Define processes for:

  • The implementation of a study DMS including its ongoing oversight and management
  • Document identification (e.g. naming, version control)
  • DMS training of study staff
  • The incorporation of user feedback regarding implemented documents

Keep a document tracking list within each TMF/ISF folder in order to maintain overview of current and archived documents.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Instruction for EC submission

Swissmedic – see in particular

  • Guidelines for CTA dossiers submitted

References

ICH GCP E6(R2) – see in particular guideline

  • 8 Essential Documents for the Conduct of a Clinical Trial

BAG – see in particular

  • BAG submission guidelines (e.g. illegal substances or stem cell therapies)
Abbreviations
  • BAG – Bundesamt für Gesundheit
  • CRF – Case Report Form
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • DMS – Document Management System
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IB – Investigator’s Brochure
  • ICF – Informed Consent Form
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • PIS – Participant Information Sheet
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Basic ↦ Documents ↦ Document Management ↦ In Studies
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 ↦ Document Management ↦ In Studies

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