# The Good Laboratory Practice Regulations 1997, Paragraph 13: Performance of the study


(1) 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.
(2) 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.

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Source: https://www.legislation.gov.uk/uksi/1997/654/schedule/2/paragraph/13 (the official version)
Page: https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.