Research Compliance Standard Operating Procedures (SOPs)

According to the FDA, 40% of clinical trials fail to meet regulatory requirements, highlighting the critical need for robust Research Compliance Standard Operating Procedures (SOPs).

In the complex world of clinical research, SOPs are your essential roadmap to success. They're not just documents; they're your guarantee of consistency, quality, and regulatory compliance. Whether you're a seasoned researcher or new to the field, mastering SOPs is crucial for conducting ethical, efficient, and compliant studies that protect participants and uphold scientific integrity.

Join us as we explore the world of Research Compliance SOPs. We'll guide you through everything from their development to real-world impact, equipping you with the knowledge to elevate your research practices and navigate regulatory landscapes with confidence. By the end, you'll have a comprehensive understanding of how SOPs contribute to research excellence and ensure compliance with ever-evolving regulations.

Key takeaways:

• SOP essentials: Discover how these crucial documents ensure consistency and compliance in your research, forming the backbone of quality clinical trials.
• Building effective SOPs: Learn the key elements that make SOPs powerful tools for research excellence, including clear objectives, detailed procedures, and regulatory references.
• SOP types in action: Explore various SOPs and their specific roles in maintaining research integrity, from informed consent to data management.
• From paper to practice: Master the art of developing and implementing SOPs in your research setting, including best practices for writing, review, and training.
• Quality management integration: See how SOPs fit into broader quality systems, supporting continuous improvement in research practices.
• Overcoming SOP challenges: Tackle common hurdles in SOP management, such as ensuring accessibility and managing updates, to keep your research on track.
• SOPs in the real world: Gain insights from case studies showing the tangible benefits of well-implemented SOPs, including enhanced data integrity and improved regulatory inspection outcomes.

What are Research Compliance Standard Operating Procedures (SOPs)?

Research Compliance Standard Operating Procedures (SOPs) are essential documents that guide ethical and consistent clinical research practices. Let's explore what they are and why they matter:

• Definition: SOPs are detailed, written procedures outlining standard practices in research settings. They act as a roadmap for consistency and compliance throughout a clinical study. SOP definitions encompass these critical elements to ensure research integrity.
• Importance in research compliance:
  • Ensure adherence to regulatory requirements and ethical standards
  • Maintain research integrity and data quality
  • Provide a framework for standardised, reliable study conduct

Clinical Research SOPs are considered a cornerstone of effective clinical research, ensuring that studies are conducted in a standardised and reliable manner.

• Key regulatory bodies and guidelines:
  • Food and Drug Administration (FDA)
  • International Council for Harmonisation (ICH GCP)
  • European Medicines Agency (EMA)

These organisations set standards that shape SOPs, ensuring research practices meet international quality and ethical benchmarks.

SOPs play a crucial role in maintaining consistency and quality by:

• Providing clear instructions for all research activities
• Facilitating employee training
• Ensuring consistent workflows
• Maintaining regulatory compliance across processes

For example, an SOP might detail the exact steps for obtaining Types of Informed Consent, ensuring every participant receives the same information and fair treatment. SOP uses extend to various aspects of research, from participant recruitment to data management and reporting.

Bottom line: SOPs are essential for research compliance, consistency, and quality in clinical trials. They minimise errors, reduce bias, and ensure all team members follow the same procedures. By implementing well-designed SOPs, you'll enhance the reliability and reproducibility of your studies, contributing to scientific advancement and the development of safe, effective treatments.

Key Elements of Effective Research Compliance SOPs

Creating effective Standard Operating Procedures (SOPs) is crucial for maintaining research compliance and operational efficiency. Let's explore the essential elements that make SOPs truly impactful:

1. Clear objectives and scope:
   • Define the SOP's purpose and application clearly
   • Example: "This SOP outlines the process for obtaining informed consent in clinical trials"
2. Detailed procedures and responsibilities:
   • Provide step-by-step instructions in plain language
   • Assign specific roles for each task
   • Tip: Use flowcharts or diagrams for complex processes
3. References to relevant regulations and guidelines:
   • Cite specific guidelines (e.g., ICH GCP, FDA regulations)
   • Keep references up-to-date with regulatory changes
4. Version control and document management:
   • Implement a robust tracking system
   • Include revision history and approval dates
   • Ensure easy access to the latest version
5. Training requirements for personnel:
   • Specify required training for each role
   • Set timelines for initial and refresher training
   • Document training completion
6. Quality control and assurance measures:
   • Incorporate periodic audits and reviews
   • Establish data verification processes
   • Implement peer review mechanisms

Pro tip: Use our SOP template to ensure you've covered all these key elements!

Bottom line: Well-structured SOPs with clear elements are crucial for maintaining research compliance and operational efficiency. They provide a roadmap for conducting research that meets regulatory standards and promotes consistency across studies and research teams. By incorporating these key elements, we help you create SOPs that not only ensure compliance but also foster a culture of quality and integrity in research practices.

Types of SOPs in Clinical Research

In clinical research, a comprehensive set of Standard Operating Procedures (SOPs) is essential to ensure compliance at every stage. Let's explore the key types of SOPs commonly used:

1. Informed consent process and documentation: Guidelines for obtaining and documenting informed consent, ensuring participants fully understand the study's purpose, risks, and benefits. This SOP should detail the step-by-step process, including how to handle special cases like vulnerable populations.
2. Data management and integrity: Procedures for collecting, storing, and managing research data, emphasising data integrity throughout the study. This SOP should cover electronic data capture systems, data validation processes, and data security measures.
3. Adverse event reporting and safety monitoring: Guidelines for identifying, documenting, and reporting adverse events, as well as ongoing safety monitoring procedures. This SOP should include timelines for reporting, classification of events, and follow-up procedures.
4. Subject recruitment and screening: Processes for identifying, recruiting, and screening potential participants, ensuring all eligibility criteria are met. This SOP should outline recruitment strategies, screening procedures, and documentation requirements.
5. Protocol deviation handling: Steps to identify, document, and address any deviations from the approved study protocol. This SOP should include a classification system for deviations and corrective action procedures.
6. Regulatory document submission: Processes for preparing and submitting required documents to regulatory authorities and ethics committees. This SOP should cover document preparation, review processes, and submission timelines.
7. Investigational product management: Procedures for handling, storage, dispensing, and accountability of investigational products. This SOP should detail temperature monitoring, expiration date tracking, and reconciliation processes.
8. Monitoring visits and audits: Guidelines for preparing and conducting internal and external monitoring visits and audits. This SOP should outline the frequency of visits, documentation requirements, and follow-up procedures.
9. GCP training and certification: Requirements and processes for ensuring research staff receive appropriate Good Clinical Practice (GCP) training and maintain certifications. This SOP should specify training frequency, acceptable training providers, and documentation requirements.

Our SOP Guidelines contain adequate detail to guide research staff through each procedure, establishing uniformity in everyday functions. We emphasise the importance of consistent SOP training, with systematic distribution, education, and training on new departmental SOPs.

Bottom line: A comprehensive set of SOPs covers all aspects of clinical research, ensuring compliance at every stage. By implementing and following these SOPs, research teams can maintain high standards of quality, protect participant safety, and ensure the integrity of their research data.

Developing and Implementing Research Compliance SOPs

Developing and implementing effective Research Compliance Standard Operating Procedures (SOPs) is a critical process that requires careful planning, execution, and ongoing management. At None, we understand the challenges you face in creating SOPs that ensure research compliance while maintaining efficiency. Let's explore the key steps and best practices for creating and maintaining SOPs that will elevate your research compliance efforts.

Steps in SOP Development

The development of SOPs typically follows a structured process:

1. Planning: Identify the need for the SOP and define its scope and objectives. For example, you might recognise the need for a new SOP on data management after noticing inconsistencies in data handling across different research teams.
2. Drafting: Write the initial version of the SOP, focusing on clarity and accuracy. Involve subject matter experts to ensure all relevant aspects are covered.
3. Reviewing: Have relevant stakeholders review the draft and provide feedback. This could include researchers, compliance officers, and quality assurance personnel.
4. Approving: Obtain final approval from authorized personnel before implementation. This step ensures that the SOP aligns with organisational policies and regulatory requirements.

Best Practices for Writing Clear and Concise SOPs

When crafting SOPs, clarity and concision are paramount. Here are some best practices we recommend:

• Use simple, straightforward language to ensure understanding across all levels of staff
• Organize content logically with numbered steps for easy reference
• Define any technical terms or acronyms to avoid confusion
• Include specific details without being overly verbose
• Use active voice and present tense for instructions to improve readability

Incorporating Visual Aids

Visual aids can significantly enhance the comprehension and usability of SOPs. Consider including:

• Flowcharts to illustrate complex processes, such as the steps for reporting adverse events
• Diagrams to explain equipment setup or sample handling procedures
• Checklists for critical steps or safety procedures, like protocol deviation reporting

These visual elements can help reduce errors and improve compliance by providing clear, easy-to-follow guidance.

Strategies for Effective SOP Implementation

Implementing SOPs effectively requires a strategic approach. At None, we've found these strategies to be particularly effective:

• Communicate the importance of SOPs to all staff through regular meetings and training sessions
• Ensure easy access to SOPs through a centralized, user-friendly system
• Integrate SOPs into daily workflows and processes to make compliance a natural part of operations
• Encourage feedback from users for continuous improvement, perhaps through a dedicated feedback channel

Training Personnel on New and Updated SOPs

Proper training is crucial for ensuring that SOPs are followed correctly. We recommend:

• Developing comprehensive training programs for new and updated SOPs
• Using a mix of training methods (e.g., in-person sessions, online modules, hands-on workshops)
• Providing hands-on practice opportunities when applicable, such as simulated data entry exercises
• Assessing understanding through quizzes or practical demonstrations
• Maintaining training records to track completion and compliance

Periodic Review and Update Processes

SOPs should be living documents that evolve with changing regulations and best practices:

• Establish a regular schedule for SOP reviews (e.g., annually or bi-annually)
• Assign responsibility for initiating and overseeing reviews to specific team members
• Gather feedback from users and stakeholders during the review process
• Update SOPs promptly when regulations or procedures change
• Maintain a version control system to track changes and approvals

Bottom line: Careful development and implementation of SOPs are critical for their effectiveness in ensuring research compliance. By following these steps and best practices, you can create robust SOPs that support high-quality research while maintaining regulatory compliance. Remember, well-crafted SOPs are not just documents—they're the backbone of your research integrity and quality assurance efforts.

SOPs and Quality Management Systems (QMS) in Clinical Research

Imagine Standard Operating Procedures (SOPs) as the essential building blocks of a robust Quality Management System (QMS) in clinical research. They work together seamlessly, ensuring your research remains compliant and of the highest quality.

Here's how SOPs support your overall quality objectives:

• Consistency champion: SOPs ensure everyone on your team follows the same playbook, reducing errors and variability in processes.
• Data integrity guardian: With clear SOPs, you'll collect, manage, and report data more accurately and reliably.
• Patient safety sentinel: SOPs outline crucial safety protocols, minimising risks to your trial participants.
• Efficiency booster: Well-crafted SOPs streamline processes, saving you valuable time and resources.

Integrating SOPs into your broader QMS framework is like assembling a complex puzzle. Your QMS is the big picture – the organisational structure, responsibilities, and resources for quality management. SOPs are the detailed instructions that bring this picture to life in your day-to-day operations.

SOPs play a vital role in continuous improvement processes within the QMS:

1. Identifying areas for enhancement
2. Implementing changes systematically
3. Monitoring the effectiveness of these changes
4. Updating procedures based on new findings or regulatory requirements

As clinical research evolves, so should your SOPs and QMS. SOPs and QMS Evolution is crucial for addressing the complex challenges of modern clinical research. Adapting to new technologies, methodologies, and regulatory requirements can give you a competitive edge while maintaining compliance.

Bottom line: SOPs are integral components of a robust Quality Management System, supporting overall research compliance and quality goals. They provide the necessary structure and guidance to ensure that clinical research is conducted consistently, efficiently, and compliantly. By investing in solid SOPs, you're paving the way for developing safe, effective treatments that can make a real difference in patients' lives.

Remember, at None, we're here to help you navigate the complex world of clinical research compliance. Our team of experts can guide you in developing and implementing SOPs that align perfectly with your QMS and research goals, ensuring your studies meet the highest standards of quality and regulatory compliance.

Overcoming Challenges in SOP Management

Managing Standard Operating Procedures (SOPs) effectively is crucial for research compliance, but it comes with its own set of challenges. Let's explore some common hurdles and strategies to overcome them:

Ensuring accessibility and visibility of SOPs

One of the primary challenges in SOP management is making sure that all relevant personnel can easily access and find the documents they need. To address this:

• Implement a centralised document management system
• Create a user-friendly interface for browsing and searching SOPs
• Develop a clear naming convention and organisation structure

Consider colour-coding SOPs by department to significantly improve visibility and ease of access.

Maintaining up-to-date content

Keeping SOPs current is essential for maintaining compliance. Here's how to stay on track:

• Establish a regular review schedule for all SOPs
• Assign responsibility for updates to specific individuals or teams
• Implement a version control system to track changes

Pro tip: Set up automated reminders for scheduled reviews to ensure timely updates.

Addressing resistance to change

Introducing new or updated SOPs can sometimes meet with resistance from staff. To mitigate this:

• Involve key stakeholders in the SOP development process
• Provide clear explanations for changes and their benefits
• Offer comprehensive training on new procedures

Consider appointing "SOP champions" within each team to advocate for new procedures and support their colleagues during the transition.

Balancing detail with usability

SOPs need to be thorough, but overly complex documents can hinder compliance. To strike the right balance:

• Use clear, concise language
• Incorporate visual aids like flowcharts and diagrams
• Break down complex procedures into manageable steps

Remember, the goal is to create SOPs that are both comprehensive and user-friendly.

Ensuring cross-departmental alignment

Research often involves multiple departments, each with its own processes. To ensure alignment:

• Establish cross-functional teams for SOP development
• Conduct regular meetings to discuss interdepartmental issues
• Create a research integrity committee to oversee compliance across departments

Regular communication and collaboration between departments are key to maintaining consistent SOPs across the organisation.

Leveraging technology for SOP management

Modern technology can significantly streamline SOP management. Consider:

• Implementing electronic document management systems
• Using workflow automation tools for review and approval processes
• Exploring AI-powered solutions for content updates and version control

Investing in a robust electronic system can save time, reduce errors, and improve overall SOP management efficiency.

Bottom line: Proactive management and innovative solutions can overcome common challenges in SOP implementation and maintenance. By addressing these challenges head-on, organisations can enhance their research compliance, improve operational efficiency, and ultimately contribute to higher-quality research outcomes. Remember, well-managed SOPs are the backbone of quality research – let's make them work for us, not against us!

Case Studies: SOPs in Action

Let's explore three real-world examples that showcase the impact of well-implemented Research Compliance SOPs in clinical research.

Example 1: Enhancing Data Integrity in a Multi-Site Clinical Trial

Challenge:
A large-scale, multi-site clinical trial faced significant challenges in maintaining consistent data integrity across different locations.

Solution:
The research team implemented comprehensive SOPs with clear, step-by-step instructions for data collection, entry, and validation.

Results:

• 30% reduction in data discrepancies
• 25% decrease in query resolution time
• Accelerated data analysis and reporting phases

Key Insight: Standardised procedures across all sites significantly improved data quality and consistency, enhancing the overall study quality and efficiency.

Example 2: Streamlining Adverse Event Reporting

Challenge:
A pharmaceutical company struggled with delays and inconsistencies in adverse event reporting, potentially compromising patient safety and regulatory compliance.

Solution:
New SOPs were developed, clearly outlining the reporting process, timelines, responsible personnel, and required documentation.

Results:

• 40% decrease in reporting times
• 35% improvement in report accuracy
• Enhanced patient safety monitoring
• Improved standing with regulatory bodies

Key Insight: Clear, well-defined processes dramatically improved critical safety procedures, benefiting both patients and the company's regulatory relationships.

Example 3: Improving Regulatory Inspection Outcomes

Challenge:
A biotech firm faced recurring issues during regulatory inspections due to inconsistent practices across different departments.

Solution:
The company developed and implemented comprehensive Clinical Research SOPs, standardising processes across all departments.

Results:

• 50% reduction in inspection observations
• No critical findings in subsequent inspections
• Expedited approval process for new drug application
• Improved company reputation in the industry

Key Insight: Well-organised, consistently followed procedures significantly improved regulatory compliance, leading to tangible benefits in the approval process and company standing.

Lessons Learned and Best Practices

1. Prioritise consistency: Standardise SOPs across all sites and departments to ensure uniform practices.
2. Keep SOPs current: Regularly review and update SOPs to reflect current best practices and regulatory requirements.
3. Invest in comprehensive training: Ensure all staff understand and can effectively implement the SOPs through ongoing education.
4. Communicate clearly: Use concise, unambiguous language in SOP documentation to minimise misinterpretation and errors.
5. Leverage technology: Utilise electronic systems for improved SOP management, accessibility, version control, and compliance tracking.
6. Measure impact: Regularly assess the effectiveness of SOPs and make data-driven improvements.
7. Encourage feedback: Create channels for staff to provide input on SOPs, fostering a culture of continuous improvement.

Bottom Line

These case studies clearly demonstrate the significant benefits of well-implemented Research Compliance SOPs in clinical research settings. From enhancing data integrity and streamlining critical processes to improving regulatory compliance, SOPs play a crucial role in ensuring the success and credibility of clinical trials. By investing time and resources in developing, maintaining, and continually improving robust SOPs, research organisations can significantly enhance their operational efficiency, data quality, and regulatory standing. At None, we've observed how this commitment to excellence in SOPs can transform research operations, leading to better outcomes for both researchers and patients.

Summary: SOPs Crucial for Robust Research Compliance

As we wrap up our journey through Research Compliance SOPs, let's reflect on why they're so crucial for your research integrity. SOPs are the backbone of any robust research compliance program, playing a pivotal role in ensuring consistency, quality, and adherence to regulatory requirements across all research activities.

To develop effective SOPs:

1. Clearly define objectives and scope for each SOP
2. Involve stakeholders in the development process
3. Use clear, concise language and incorporate visual aids
4. Establish a regular review and update cycle
5. Provide comprehensive training on SOP implementation

Looking ahead, the future of SOP management is evolving with technological advancements. We're likely to see trends such as AI-assisted updates to keep SOPs current with changing regulations (e.g., automated regulatory tracking systems that flag when SOPs need revision), and closer integration with Clinical Trial Management Systems (CTMS) for streamlined workflows.

The importance of continuous learning and adaptation in SOP management cannot be overstated. Research reproducibility heavily relies on well-crafted SOPs that provide clear direction and instructions to avoid deviations. This underscores the need for ongoing refinement of SOPs based on practical experience and emerging best practices.

To stay updated on research compliance regulations and best practices, consider resources such as:

• Regulatory agency websites (e.g., FDA, EMA)
• Professional associations in clinical research
• Compliance-focused webinars and conferences
• Peer-reviewed journals in research ethics and compliance

We encourage you to take a fresh look at your SOPs. Are they serving you as well as they could be? Pharmaceutical compliance demands that SOPs are essential for ensuring quality, compliance, and safety across all operations. By continuously improving your SOPs, you're not just meeting regulatory requirements – you're elevating the standard of your research.

Remember, you're at the forefront of maintaining research integrity. Clinical trial compliance relies on SOPs to maintain consistency and adherence to regulations throughout the research process, ensuring reliable results. Your commitment to developing, implementing, and following well-designed SOPs contributes significantly to the advancement of ethical and high-quality research.

Stay vigilant, stay compliant, and keep pushing the boundaries of excellence in research through robust SOPs. Your dedication doesn't just meet regulations – it elevates the entire field of research.

Best regards,
[Your Name]
Research Compliance Specialist

FAQs: Compliance and Control SOPs in Clinical Research

• What is a compliance and control SOP in clinical research?

Compliance and control SOPs in clinical research are essential documents that outline detailed procedures for maintaining regulatory compliance and quality control throughout a study. These SOPs ensure consistency and adherence to regulations, institutional policies, and Good Clinical Practice (GCP) guidelines. They provide specific instructions for various processes related to maintaining regulatory compliance and quality control, serving as a cornerstone for research integrity.

• How often should compliance and control SOPs be reviewed and updated?

Best practice dictates that compliance and control SOPs should be reviewed annually. However, it's crucial to also review these SOPs before significant sponsor interactions or when there are changes in regulations or institutional policies. This ensures that SOPs always reflect the most current practices and regulatory requirements, maintaining the study's compliance and quality standards.

• Who is responsible for creating and maintaining compliance and control SOPs?

The development and maintenance of SOPs typically fall to a team of experienced researchers, subject matter experts, and designated quality assurance personnel. These individuals possess the necessary knowledge and expertise to develop comprehensive and effective SOPs that address all aspects of compliance and control in clinical research. Collaboration between these experts ensures that SOPs are both technically accurate and practically implementable.

• How do compliance and control SOPs differ from other types of SOPs in clinical research?

While other SOPs may focus on specific operational procedures, compliance and control SOPs are distinguished by their emphasis on ensuring regulatory compliance and maintaining quality control throughout the research process. These SOPs are specifically designed to address regulatory requirements, maintain research integrity, and provide a framework for consistent adherence to compliance standards across all aspects of the study.

• What are the consequences of non-adherence to compliance and control SOPs?

Non-adherence to compliance and control SOPs can have severe and far-reaching consequences, including:

1. Regulatory repercussions: FDA audits, warnings, or penalties
2. Institutional impact: Damage to the organisation's reputation and credibility
3. Data integrity issues: Protocol deviations and inconsistencies in data collection
4. Ethical concerns: Potential compromise of participant safety and well-being
5. Research validity: Undermining the scientific validity and ethical standards of the study
6. Financial implications: Increased costs due to repeated procedures or extended study timelines

Strict adherence to compliance and control SOPs is therefore crucial for maintaining the integrity, credibility, and ethical standards of clinical research.

FAQs: Compliance Screening in Clinical Research

• What is compliance screening in clinical research?

Compliance screening in clinical research is a crucial process where we evaluate potential participants against specific criteria to ensure they meet the study's requirements. This step is vital for maintaining the integrity and validity of our research data by identifying suitable participants who align with the study's objectives and safety parameters. For example, we might screen for age, medical history, or current medications to ensure participants fit the study's specific needs.

Bibliography

1. FDA. (2023). Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. [online] Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
2. Infiuss. (2023). The Importance of Standard Operating Procedures (SOPs) in Clinical Research: Enhancing Quality and Compliance - Infiuss. [online] Available at: https://infiuss.com/blog/the-importance-of-standard-operating-procedures-sops-in-clinical-research-enhancing-quality-and-compliance.
3. Nature. (2018). Compliance with scientific rigour is not enough. [online] Available at: https://www.nature.com/articles/d41586-018-05486-2.
4. UCSF. (n.d.). SOP Guidelines | Human Research Protection Program. [online] Available at: https://hub.ucsf.edu/sops.
5. EPA. (n.d.). Good Laboratory Practice Standards. [online] Available at: https://www.epa.gov/sites/default/files/2015-06/documents/g6-final.pdf.
6. TechTarget. (n.d.). standard operating procedure (SOP). [online] Available at: https://www.techtarget.com/searchbusinessanalytics/definition/standard-operating-procedure-SOP.
7. Cloudbyz. (2023). Enhancing Data Integrity in Clinical Trials: Key Strategies. [online] Available at: https://www.cloudbyz.com/resources/edc/enhancing-data-integrity-in-clinical-trials-key-strategies/.
8. Advarra. (2021). Data Collection in Clinical Trials: 4 Steps for Creating an SOP. [online] Available at: https://www.advarra.com/blog/data-collection-in-clinical-trials-4-steps-for-creating-an-sop/.
9. BioPharma Services. (2023). The Role of Clinical Trial SOPs and Quality Management Systems. [online] Available at: https://www.biopharmaservices.com/blog/the-role-of-clinical-trial-sops-and-quality-management-systems/.
10. University of Utah. (n.d.). SOP Library | Quality Compliance. [online] Available at: https://qualitycompliance.research.utah.edu/sop-library/.
11. National Institutes of Health. (n.d.). Data and Safety Monitoring. [online] Available at: https://www.niams.nih.gov/grants-funding/conducting-clinical-trials/clinical-trial-policies-guidelines-and-templates/data-and.
12. ACRP. (2023). Guidance for Preparing Standard Operating Procedures (SOPs). [online] Available at: https://acrpnet.org/2023/10/17/guidance-for-preparing-standard-operating-procedures-sops/.
13. Kent State University. (n.d.). Clinical Research Standard Operating Procedures | Research and Sponsored Programs. [online] Available at: https://www.kent.edu/research/office-research-compliance/clinical-research-standard-operating-procedures.