Warning Letter: eCRF lacks laboratory values (ucm340269)

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Ofni Systems

As an investigator, you are responsible for maintaining accurate, complete, and current records relating to the investigation. (See 21 CFR 812.140(a)). You failed to adhere to the above-stated regulations. Examples of these failures include, but are not limited to the following: a. (b)(6) • The Electronic Case Report Form (eCRF) lacks baseline vital signs, permanent pacemaker) interrogation findings, or laboratory values.

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