Your Easy Guide to Clinical Studies

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/IMD 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 (e.g. dispensation log) 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
• *Note to File*:  to document an event and the implemented proactive steps to prevent this event from happening again
• Essential document tracking log: lists for each document the created versions and those that were accepted by the Ethics Committee (EC), and if applicable Swissmedic

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As a SP-INV/Site-INV, 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 on how to implement study logs and their required filing system (e.g. filing of Note to Files in the study TMF/ ISF)

 

During study conduct:

• Ensure study logs are current and access protected, and only available to study staff
• Ask for 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