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"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA

Without tracking, you are relying on memory and impression, both notoriously unreliable

The Society recognizes that it must assume, also, a role of advocacy for those who are defenseless or voiceless

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