Protocol for Data Capture and Record-keeping in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic collection, recording, and management of data generated during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in data collection, including Study Coordinators, Clinical Research Associates (CRAs), Laboratory Technicians, and Data Managers.

Responsibilities

• The Study Coordinator is responsible for overseeing data collection activities, ensuring compliance with the study protocol and regulatory requirements.
• The Clinical Research Associate (CRA) is responsible for monitoring data collection procedures at the study site and verifying the accuracy and completeness of study records.
• The Laboratory Technician is responsible for documenting analytical results, instrument readings, and sample handling procedures according to established protocols.
• The Data Manager is responsible for maintaining study databases, organizing and archiving study documents, and ensuring data integrity and security.

Procedure

1. Develop a data collection plan outlining the types of data to be collected, data sources, collection methods, and responsible personnel.
2. Train study personnel on data collection procedures, including proper documentation techniques, data entry protocols, and confidentiality requirements.
3. Collect data systematically and accurately using standardized data collection forms, electronic data capture systems, or laboratory notebooks.
4. Record data promptly and legibly, ensuring that all entries are dated, signed, and attributed to the appropriate source or personnel.
5. Review data for completeness, consistency, and accuracy, resolving any discrepancies or missing information promptly with the relevant study personnel.
6. Store and maintain study documents and data records in a secure and organized manner, following established procedures for document retention and archiving.
7. Ensure that data management procedures comply with regulatory requirements, including data privacy, confidentiality, and Good Clinical Practice (GCP) guidelines.
8. Regularly backup study databases and electronic records to prevent data loss or corruption, and implement appropriate access controls to protect sensitive information.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• GCP – Good Clinical Practice

Documents

• Data Collection Plan
• Data Collection Forms
• Study Database
• Data Management SOP

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for data collection and documentation in clinical trials.

SOP Version

Version 1.0