What is it? Why is it important?

A study is closed once the last study participant has had the last study visit.

 

Upon study closure, various activities are implemented, such as:

What do I need to do?

As a SP-INV and Site-INV finalize the document management of your study, and prepare documents/records for archiving:

  • Date and sign the study CRF (electronic and paper)
  • Establish a document filing system that guarantees document identification and traceability. Allows for easy retrieval of documents at some later date.
  • Ensure TMF/ISF filing of study relevant essential documents/records and logs (i.e. ensure filing is complete and applicable documents are dated and signed)
  • Ensure all study documents/records and study data comply with ALCOAO principles. These principles define that data must be Attributable, Legible, Contemporaneous, Original, and Accurate. Thus, changes must be traceable (dated and signed), and corrected entries must remain identifiable. In eCRFs, an integrated audit trail takes on that task
  • In the event study documents / records are copied, ensure compliance with the requirements for “certified copies

More

ALCOA-O principles state that data must be:

  • Attributable - it must be clear to which participant they belong
  • Legible - they must be readable
  • Contemporaneous - they must be noted immediately after the data is generated
  • Original - they must be the original
  • Accurate - they must be reliably correct
  • Originator information – who entered the data and when
  • Thus, changes must be traceable (dated and signed), and corrected entries must remain identifiable.

Where can I get help?

Your local Research Support Centre can assist you with experienced staff regarding this topic

  • Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

  • Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

  • Bern, Department of Clinical Research (DCR), dcr.unibe.ch

  • Geneva, Clinical Research Center (CRC), crc.hug.ch

  • Lausanne, Clinical Research Center (CRC), chuv.ch

  • St. Gallen, Clinical Trials Unit (CTU), h-och.ch

  • Zürich, Clinical Trials Center (CTC), usz.ch

References

ICH GCP E6(R3) – see in particular

  • Appendix C. Essential records for the conduct of a clinical trial
Abbreviations
  • ALCOA – Attributable Legible Contemporaneous, Original Accurate
  • CRF – Case Report Form (p – paper; e – electronic)
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • (S)AE – (Serious) Adverse Event
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Completion ↦ Documents ↦ Required Documents ↦ Study Closure
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Completion ↦ Documents ↦ Required Documents ↦ Study Closure

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