Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

3. Summary statistics and
raw analysis outputs
• With regard to the provision of raw data in electronic
format, the guidance document is inconsistent
regarding whether this is a default requirement or “on
request”.
– Please clarify.
• The guidance document states that “The statistical
analysis programs, logs and outputs should be
provided for the purposes of review”.
– To provide all this information by default seems excessive.
– Please clarify whether this is a default requirement or “on
request”.
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