Standard Operating Procedure (SOP) for Documentation and Record-Keeping in Drug Discovery

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the process for proper documentation and record-keeping throughout drug discovery projects. Accurate and thorough documentation is essential for regulatory compliance, maintaining data integrity, ensuring reproducibility, and facilitating effective communication among project teams. This SOP ensures that all data, protocols, experimental results, and project-related documents are consistently captured, stored, and accessible for future reference.

2) Scope

This SOP applies to all documentation and record-keeping activities within drug discovery, including preclinical research, clinical trials, and regulatory submissions. It covers the management of laboratory notebooks, experimental records, data logs, regulatory documents, and intellectual property records. This SOP is relevant to all personnel involved in drug discovery, including scientists, project managers, data managers, regulatory affairs teams, and quality assurance staff.

3) Responsibilities

• Project Managers: Responsible for overseeing documentation and record-keeping activities, ensuring compliance with this SOP, and ensuring that all records are complete and properly maintained throughout the drug discovery process.
• Research Scientists: Responsible for documenting experimental procedures, data, and results accurately and in a timely manner. They ensure that laboratory notebooks and records are up to date and properly stored.
• Data Managers: Responsible for organizing and maintaining all project-related data, ensuring that electronic records are properly stored, backed up, and accessible for analysis and review.
• Regulatory Affairs: Ensures that all regulatory documents, such as trial protocols, consent forms, and regulatory filings, are accurately documented and maintained in compliance with relevant regulations.
• Quality Assurance (QA): Ensures that the documentation practices meet internal quality standards and comply with regulatory requirements, such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP).

4) Procedure

The following steps outline the detailed procedure for documentation and record-keeping in drug discovery projects:

1. Step 1: Establish Documentation Standards
   1. Define the types of documents to be maintained during the drug discovery process, including laboratory notebooks, experimental data logs, project reports, and regulatory submissions.
   2. Establish standardized formats for documenting data, ensuring that all records include necessary information such as the experiment date, methodology, results, conclusions, and signatures (where applicable).
   3. Ensure that all project-related documents are properly labeled, version-controlled, and organized to ensure easy retrieval and traceability.
2. Step 2: Document Data and Experimental Procedures
   1. Document all experimental protocols, observations, and results in a timely and consistent manner. Ensure that the data is clear, legible, and reproducible.
   2. For laboratory experiments, use bound laboratory notebooks or electronic lab notebooks (ELNs) to record raw data, observations, and any changes to the experimental procedure during execution. Entries should be signed and dated to confirm their authenticity.
   3. Ensure that data logs, including raw data, intermediate results, and analysis, are securely stored and backed up regularly. Data should be easily accessible for future reference and regulatory audits.
3. Step 3: Manage Electronic Records
   1. Implement electronic systems for managing digital records, including data analysis, experiment logs, and project documentation. Use secure, centralized systems for data storage and sharing, such as a Document Management System (DMS) or an electronic lab notebook (ELN).
   2. Ensure that all electronic records are stored in a format that is both secure and easily accessible, with regular backups to prevent data loss.
   3. Document any changes or revisions to electronic records, ensuring that version control is applied and all modifications are tracked for auditing purposes.
4. Step 4: Regulatory Documentation
   1. Ensure that all regulatory documentation, including clinical trial protocols, investigator brochures, and informed consent forms, is properly documented and stored in accordance with regulatory requirements.
   2. Maintain copies of all regulatory submissions, approvals, and correspondence with regulatory agencies (e.g., FDA, EMA). Ensure that these documents are easily retrievable for compliance reviews or audits.
   3. Ensure that all regulatory documents are stored securely and are only accessible to authorized personnel. Maintain proper records of any amendments or updates to regulatory documents.
5. Step 5: Intellectual Property Documentation
   1. Document all intellectual property (IP)-related activities, including patent filings, non-disclosure agreements (NDAs), and licensing agreements.
   2. Ensure that new discoveries, inventions, or innovations related to the drug candidate are documented immediately to protect intellectual property rights. This includes detailed descriptions of discoveries, experimental results, and technical data that support patent filings.
   3. Store IP-related documentation in a secure, centralized location to ensure that it is easily accessible for review and reference when needed.
6. Step 6: Record Retention and Archiving
   1. Establish a record retention policy that defines how long various types of records (e.g., laboratory notebooks, project reports, regulatory filings) should be retained. Ensure that records are stored for the required period in accordance with organizational policies and regulatory requirements.
   2. When records are no longer needed for active projects, archive them securely to prevent unauthorized access or loss of information. Archived records should be stored in an organized, searchable manner for future reference and compliance audits.
   3. Ensure that any physical records are stored in a safe, secure location, while electronic records should be backed up regularly and stored on secure servers or cloud systems.
7. Step 7: Documentation Review and Auditing
   1. Implement a system for regularly reviewing and auditing documentation to ensure its accuracy, completeness, and compliance with regulatory requirements.
   2. Conduct internal audits of project records, including experimental data, regulatory filings, and IP documentation, to identify any discrepancies or gaps in documentation practices.
   3. Provide feedback and corrective actions to project teams as necessary to ensure that documentation practices remain consistent and compliant with internal quality standards and regulatory requirements.
8. Step 8: Documentation Access and Confidentiality
   1. Ensure that all documentation is only accessible to authorized personnel based on their role and project involvement. Implement role-based access controls for electronic records to protect sensitive information.
   2. Maintain confidentiality agreements for all personnel involved in handling sensitive documentation, including proprietary data, intellectual property, and clinical trial information.
   3. Monitor access to documentation to ensure that it is not misused or disclosed without appropriate authorization. Maintain logs of all access to critical project data and records.

5) Abbreviations

• IP: Intellectual Property
• QA: Quality Assurance
• GLP: Good Laboratory Practices
• GCP: Good Clinical Practices
• ELN: Electronic Lab Notebook
• DMS: Document Management System

6) Documents

The following documents should be maintained throughout the documentation and record-keeping process:

1. Laboratory Notebooks
2. Experimental Data Logs
3. Project Reports and Protocols
4. Regulatory Submissions and Approvals
5. Intellectual Property Records
6. Record Retention and Archiving Logs

7) Reference

References to regulatory guidelines and scientific literature that support this SOP:

• FDA Guidelines for Good Laboratory Practices (GLP)
• ICH Guidelines for Good Clinical Practice (GCP)
• ISO 9001:2015 Quality Management Standards

8) SOP Version

Version 1.0