Protocol for Data Input and Handling in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the accurate, timely, and secure entry 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 entry and management activities, including Study Coordinators, Data Managers, Clinical Research Associates (CRAs), and Laboratory Technicians.

Responsibilities

• The Study Coordinator is responsible for overseeing data entry and management procedures, ensuring compliance with the study protocol and regulatory requirements.
• The Data Manager is responsible for maintaining study databases, overseeing data entry processes, and ensuring data integrity, security, and compliance.
• The Clinical Research Associate (CRA) is responsible for monitoring data entry activities, verifying the accuracy and completeness of data entered, and resolving any discrepancies or issues.
• The Laboratory Technician is responsible for documenting analytical results and sample information accurately and promptly, following established procedures and protocols.

Procedure

1. Develop a data entry plan outlining the procedures, tools, and resources for data entry, including data entry forms, electronic data capture systems, and data validation checks.
2. Train study personnel on data entry procedures, including data entry software, data validation rules, and quality assurance measures.
3. Ensure that data entry personnel have appropriate access permissions to the study database or electronic data capture system and are trained on data security and confidentiality policies.
4. Enter data accurately and promptly into the designated data entry system, following standard data entry conventions and validation rules.
5. Perform regular data quality checks and validation procedures to identify and correct data entry errors, inconsistencies, or missing information.
6. Document all data entry activities, including date and time of entry, personnel responsible, and any corrective actions taken to resolve data discrepancies.
7. Maintain backup copies of study databases and electronic records to prevent data loss or corruption, and implement appropriate data encryption and access controls.
8. Archive study data and records according to established procedures and regulatory requirements, ensuring data integrity and accessibility for future reference or regulatory inspections.

Abbreviations

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

Documents

• Data Entry Plan
• Data Entry Forms
• Data Management SOP
• Data Quality Check Records

Reference

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

SOP Version

Version 1.0