Data Collection, Data Management and Document Control

Data Collection and Data Management

Study data will be collected in adherence with the study protocol and SOPs. Data will be recorded promptly, legibly, and in ink. The use of pencils, white out, correction tape, and erasers in GLP studies is strictly prohibited. Manually recorded data will include identification of the study, test system identification, date, name of person obtaining and recording the data, and all other information necessary for the reconstruction of the study. Corrections or changes to raw data and facility operational and administrative records (i.e., equipment logs, training records, room maintenance records, reagent logs) will be done so as not to obscure the original entry, will be dated at the time of the change, will identify the person making the change, and will give the reason for the change or correction.

Automated data systems generating, measuring, or assessing data will identify the person responsible for data entry or assessment at the time of entry. Electronic records, including environmental control records, will meet GLP requirements and 21 CFR, Part 11, Electronic Records, Electronic Signature regulations (as applicable). Corrections or changes to electronic records will not obscure the original entry and will be dated at the time of the change, will identify the person making the change, and will give the reason for the change or correction. When software does not provide audit trails, solutions designed to meet regulatory requirements will be developed in cooperation with the Texas A&M department responsible for managing information technology at the facility. Electronic records will be retained in accordance with the GLP regulations.

Access to GLP study data will be restricted to authorized personnel during the period of conduct of the study and after conclusion of the study. Data control procedures will be established by each organizational unit and adhered to by study personnel.

Electronic records will be maintained on secure systems with access limited to authorized personnel. Electronic study files will be organized in a manner that allows for expedient retrieval by authorized personnel. Computer systems or networks used to store electronic records will be backed up in accordance with Texas A&M policies and procedures approved by the institution information technology department.

Document Control

GLP study protocols, amendments, standard operating procedures, and forms used in data collection will be maintained as controlled documents to ensure that personnel involved in the direction or conduct of GLP studies are using the correct version of the document. Each department is responsible for establishing a procedure to ensure that only current versions of documents are distributed and used by personnel.