Question

exam lesson name: introduction to biotechnology
exam number: 700795rr
exam guidelines
exam instructions
question 16 of 20 :
select the best answer for the question.

1. which acronym refers to a set of best practices for developing documentation as described by the fda?

a. csr
b. hsp
c. crf
d. alcoa
mark for review (will be highlighted on the review page)

Explanation:

To solve this, we analyze each option:

• Option A: CSR (Clinical Study Report) is a document summarizing clinical trial results, not about documentation best practices.
• Option B: HSP is not related to FDA - defined documentation best practices.
• Option C: CRF (Case Report Form) is used to collect clinical trial data, not a set of best practices for documentation.
• Option D: ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) is the set of best practices for developing documentation as described by the FDA.

Answer:

D. ALCOA