Interim Clinical Trial (Study) Report

Interim clinical trial (clinical study) report – is a document generated during the course of a clinical trial to provide an overview of the ongoing trial progress up to a specific point in time, typically before the final analysis of all trial data is completed.

Definitions

ICH E6(R2)

1.32 Interim Clinical Trial/Study Report:

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

Purpose of Interim reports

Interim study report serves as an update to stakeholders such as regulatory authorities, sponsors, and investigators, providing documentation important for:

• monitoring the progress of given clinical study,
• identifying potential safety issues,
• identifying efficacy trends,
• making informed decisions regarding the continuation, modification, or termination of trial.

It is essential to interpret intermediate data cautiously, as periodical reports may not provide the complete picture of trial outcomes until the final analysis is conducted.

Content of Interim reports

The Interim clinical trial (study) report typically includes information on:

1. Trial progress: details on recruitment, adherence to the study protocol, and any significant deviations
2. Safety data: summary of safety concerns observed during the trial, including information on adverse events and serious adverse events
3. Efficacy data: preliminary analysis of efficacy endpoints providing insights into the effectiveness of the investigational product or intervention
4. Data quality: assessment of completeness, integrity, and overall quality to ensure the reliability and validity of trial results
5. Protocol amendments: documentation of any protocol amendments made during the trial period and their impact on trial conduct and outcomes

See also

Another relevant pages

• Clinical study reports