withdrawal of subjects from clinical trial

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Withdrawal of Subjects from clinical trial

The protocol should have a clear statement about the right of study participants to withdraw from the trial. Participants are free to withdraw from the trial at any time, without having to give any reasons and without prejudice to further treatment.

Protocol should mention the subject withdrawal criteria and procedures identifying:

Ø When and how to withdraw subjects.

Ø The type and timing of any data to be collected for withdrawn subjects.

Ø Whether subject should be replaced and if so the methods for doing this.

Ø The follow up procedures for withdrawn subjects.

Dr. Smita

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