Good Clinical Practice E6 (R3) Practice Test

What type of access to sponsor data should the investigator have?

Timely access to data, including relevant external sources. Access only after the trial ends Access limited to internal site data No access to external data

Correct Answer:

Timely access to data, including relevant external sources.

Explanation:

Timely access to data is essential for a investigator to effectively monitor safety, protect the rights and welfare of participants, and ensure data integrity throughout the trial. Having access to sponsor data, and including relevant external sources, lets the investigator see all information needed to assess risks, verify findings, and make informed decisions during the study. Delaying access until after the trial ends would prevent prompt safety actions and ongoing oversight. Limiting the view to internal site data excludes important information generated or compiled by the sponsor or external sources that can impact subject safety and trial conclusions. Not having access to external data similarly restricts the ability to evaluate the full context of the trial results.

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