What is it? Why is it important?

Logs are records that provide official proof of a performed activity or task. In studies a variety of logs are in use, such as a:

  • Training Log: records staff trainings (e.g. SOP, study protocol, IMP handling)
  • Delegation Log: records delegated tasks and responsibilities within a study team
  • Screening Log: documents participants screened for study participation
  • Recruitment Log: lists participants recruited for study participation
  • Participant Identification Log: matches participant study ID with participant identifiers (e.g. name, date of birth)
  • IMP Accountability Log: records IMP/IMD stored and dispensed at the study site during study conduct
  • Destruction Log: records destruction of IMP/IMD and applicable study material
  • Site Visit Log: documents performed monitoring visits at a given study site
  • Protocol Deviation Log: lists deviations to the study protocol during study conduct

More

Logs provide important information on the conduct of a study. Incomplete or missing logs can indicate study mismanagement, which could potentially endanger participant safety and the quality of study data.

Based on data protection laws, the identity of study participant must be protected at all times. Thus, the Participant-Identification-Log must remain at the study site and never be disclosed to the SP-INV of the study, or any other third party

What do I need to do?

When preparing your study:

  • Define and make a list of required logs
  • Consult experts to ensure logs are correctly designed able to include all required data
  • If applicable, include a test phase with the aim to validate logs based on their applicability and robustness, This is especially useful when documenting complex processes involving different study team members, even departments (e.g. blood sampling and biobank storage)
  • Ensure study staff is trained

During study conduct:

  • Ensure study logs are current and access protected, and only available to study staff
  • Ask for WI user feedback in order to include improvement measures
  • Perform regular quality checks to ensure logs are correctly filled in
  • Consider retraining in the event of poorly completed logs

Where can I get help?

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

Abbreviations
  • CTU – Clinical Trials Unit
  • ID – Identification
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Basic ↦ Documents ↦ Logs ↦ Purpose
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 ↦ Logs ↦ Purpose

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