What is it? Why is it important?

At the Site Initiation Visit (SIV) the monitor prepares the site for study start. As the correct handling of study documents is essential for the documentation of study conduct, an important aim is to train study staff on document management.

Study documents that are handled during study conduct include:

  • The study protocol
  • The PIS and ICF
  • Various logs such as the delegation, training, screening, inclusion, identification, monitoring visit, drug accountability, sampling, temperature
  • Guidelines for IMP handling: pharmacy manual, shipment documents
  • Safety documents: SAE reporting documents, IB, product information (IMP) / instruction for use (IMD)
  • EC/RA approval certificates
  • The study CRF, in paper and/or electronic form
  • Source documents
  • Quality documents: SOP, WIs, checklists
  • Study management documents: insurance, contracts, communication
  • Advertisement, patient compensation, worksheets, questionnaires
  • etc.

What do I need to do?

As a SP-INV and Site-INV define and delegate document management responsibilities to a qualified staff member.

Document management responsibilities to ensure that:

  • The ongoing oversight of study documents is guaranteed (e.g. draft-, currently active- versus archived documents)
  • Essential documents are filed in a current and complete manner both in the TMF and/or ISF
  • Only current and EC/RA approved documents remain in circulation and consequently used in the study (e.g. ICF, PIS, study protocol)
  • Study logs are complete and kept current
  • Study documents are locked away and access protected, but made available to study staff who need them for the execution of their study tasks

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

  • 4.9 Records and Reports
  • 5.5 Record Keeping
  • 8 Essential Documents for the Conduct of a Clinical Trial
Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IMP – Investigational Medicinal Product
  • IB – Investigator’s Brochure
  • ISF – Investigator Site File
  • ICF – Informed Consent Form
  • IMD – Investigational Medical Device
  • PIS – Participant Information Sheet
  • SAE – Serious Adverse Event
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedure
  • TMF – Trial Master File
  • WI – Working Instruction
Set-Up ↦ Documents ↦ Required Documents ↦ Study Initiation
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): Set-Up ↦ Documents ↦ Required Documents ↦ Study Initiation

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