Paragraph 13 Performance of the study

Purpose: To verify that written study plans exist and that the plans and the conduct of the study are in accordance with good laboratory practice principles.

The inspectors should check that—

• the study plan was signed by the study director,

• any amendments to the study plan were signed and dated,

• the date of the agreement to the study plan by the sponsor was recorded (where applicable),

• measurements, observations and examinations were in accordance with the study plan and relevant standard operating procedures,

• the results of these measurements, observations and examinations were recorded directly, promptly, accurately and legibly and were signed (or initialled) and dated,

• any changes in the raw data, including data stored in computers, did not obscure previous entries, included the reason for the change and were signed and dated,

• computer-generated or stored data have been identified and that the procedures to protect them against unauthorised amendments or loss are adequate,

• the computer software used within the study is reliable, accurate, and can be validated,

• any unforeseen events recorded in the raw data have been investigated and evaluated,

• the results presented in the reports of the study (interim or final) are consistent and complete and that they correctly reflect the raw data.