FDA 483 - Capstone Clinical Trials, Inc. - February 17, 2009

Capstone Clinical Trials, Inc. in Birmingham, AL, received a Form FDA 483 with five observations related to clinical trial conduct. The inspection revealed issues including inadequate documentation for subject unblinding, lack of IRB approval for off-site study activities and subject reimbursement, and discrepancies in study closure reporting. Additionally, the firm failed to accurately document delegation of duties and did not adhere to the protocol for subject randomization.