A pharmaceutical company is conducting a Phase II clinical trial and requires proper documentation to ensure compliance with good clinical practice (GCP). The clinical research associate (CRA) notices missing participant signatures on informed consent forms. Why is proper documentation critical in this scenario? Select one: a. It allows researchers to modify data without external review. b. It helps pharmaceutical companies avoid regulatory scrutiny. c. It is only necessary for FDA-regulated trials. d. It ensures transparency and adherence to ethical and legal requirements.
[Verified Answer]: A pharmaceutical company is conducting a…
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