Investigator's Brochure - The Road Map for Investigators

The Investigator's Brochure (IB) is a crucial document in the realm of clinical research and drug development. It serves as a comprehensive reference guide for investigators, typically medical professionals conducting clinical trials, and provides essential information about the investigational product (drug or device) being studied. The IB is a road map that helps investigators understand the scientific, medical, and safety aspects of the product, ensuring that they can conduct the trial safely and effectively.

1. Welcome INVESTIGATOR'S BROCHURE – THE ROAD MAP FOR INVESTIGATORS Praveena S M.sc Integrated Biotechnology CSRPL_STD_IND_HYD_ONL/CLS_155/082023 www.clinosol.com | follow us on social media @clinosolresearch 1 08/25/2023

2. INDEX 1. Introduction 2. Objective 3. Key components of the investigator's brochure 4. Importance of IB 5. Structure and format of the investigator's brochure 6. Overview of the investigational product 7 . Safety and efficacy data in the investigator's brochure 8. Risk assessment and management strategies 9. Significance of IB 10. Clinical investigators 11. The road map for investigators 12. Conclusion 13. Reference www.clinosol.com | follow us on social media @clinosolresearch 2 08 /25/2023

3. INVESTIGATOR'S BROCHURE (IB): INTRODUCTION: An Investigator's Brochure (IB) is a comprehensive document used in clinical trials and research studies involving investigational drugs , biologics, or medical devices. It provides essential information about the product being studied to investigators, clinical research staff, and regulatory authorities. This document serves as a comprehensive reference manual for investigators, clinical research staff, and regulatory authorities involved in the development of new drugs, biologics, or medical devices. Its purpose is to consolidate critical information about the investigational product, offering a coherent and in-depth overview of its development, properties, and safety profile. www.clinosol.com | follow us on social media @ clinosolresearch 3 08/25/2023

4. OBJECTIVE The primary objective of an Investigator's Brochure (IB) is to provide a comprehensive and standardized reference document that serves multiple purposes in the context of clinical research and drug development. 4 08 /25/2023 www.clinosol.com | follow us on social media @ clinosolresearch

5. Key Components of the Investigator's Brochure The Investigator's Brochure is a multifaceted document, comprising several key sections that collectively provide a holistic understanding of the investigational product: Product Description : This section details the investigational product's composition, formulation, and specifications, including physical and chemical characteristics. Pharmacology : It elucidates the product's mode of action, its interactions within the body, and any relevant pharmacokinetic or pharmacodynamics information. Nonclinical Studies : Summaries of preclinical studies, such as animal trials, that help establish the product's safety and efficacy before proceeding to human trials. Clinical Studies : Information on both ongoing and completed clinical trials, including study objectives, designs, patient populations, dosing regimens, and key findings. Safety Information : A comprehensive summary of known adverse events, side effects, and safety concerns related to the product, drawing from preclinical and clinical data. Dosing and Administration : Practical guidelines for dosing and administering the investigational product, addressing dosage forms, routes of administration, and storage considerations . www.clinosol.com | follow us on social media @clinosolresearch 5 08 /25/2023

6. Importance Of IB The Investigator's Brochure is a crucial document in clinical trials as it provides essential information about the investigational drug, safety data, and trial protocols. It serves as a comprehensive guide for investigators, helping them make informed decisions and ensure the safety and efficacy of the trial. Fully understanding the importance and content of the Investigator's Brochure is crucial for conducting successful clinical trials. www.clinosol.com | follow us on social media @clinosolresearch 6 08/25/2023

7. Structure and Format of the Investigator's Brochure The Investigator's Brochure follows a standardized structure and format, including sections such as Introduction, Investigational Product Information, Nonclinical Data, Clinical Data, Safety Information, and References. Each section provides specific information relevant to the trial, ensuring that investigators have a comprehensive understanding of the investigational drug and its potential benefits and risks. www.clinosol.com | follow us on social media @clinosolresearch 7 08 /25/2023

8. O verview of the Investigational Product The Investigator's Brochure provides a detailed overview of the investigational product(s) being studied in the clinical trial. It includes information about the product's composition, pharmacology, pharmacokinetics, and toxicology. Understanding the characteristics and properties of the investigational products is essential for investigators to ensure participant safety and conduct the trial effectively. www.clinosol.com | follow us on social media @clinosolresearch 8 08 /25/2023

9. Safety and Efficacy Data in the Investigator's Brochure Safety and efficacy data play a crucial role in the Investigator's Brochure. This section includes information on the results of preclinical and clinical studies, adverse events, and any benefits observed. This data helps investigators make informed decisions about the potential risks and benefits of the investigational product(s) and ensures participant safety throughout the clinical trial process. www.clinosol.com | follow us on social media @clinosolresearch 9 08 /25/2023

10. Risk Assessment and Management Strategies When conducting clinical trials, it is essential to assess and manage potential risks associated with the investigational products. This includes evaluating known risks, identifying potential hazards, and implementing effective strategies to mitigate those risks. By proactively assessing and managing risks, investigators can ensure participant safety and the overall success of the clinical trial. www.clinosol.com | follow us on social media @clinosolresearch 10 08 /25/2023

11. Significance of IB The Investigator's Brochure (IB) is of paramount significance in the realm of clinical research and drug development. Its importance lies in its role as a comprehensive and standardized reference document that serves several critical purposes : Data Quality and Integrity : The IB's meticulous documentation of preclinical and clinical study data enhances the transparency and integrity of clinical research. It provides a reference point for clinical investigators to ensure accurate data collection and reporting. Risk Management : By centralizing information about the investigational product's safety profile and potential risks, the IB helps investigators proactively identify and manage adverse events. This proactive approach contributes to risk mitigation during the trial. Consistency in Communication : The IB facilitates clear and consistent communication among all stakeholders involved in the clinical trial, including investigators, research staff, sponsors, and regulatory authorities. This consistency is vital for maintaining the integrity of the study. www.clinosol.com | follow us on social media @clinosolresearch 11 08 /25/2023

12. CLINICAL INVESTIGATORS Clinical investigators are essential figures in the field of clinical research. They are professionals, often physicians or scientists, who play a central role in designing, conducting, and overseeing clinical trials and studies. These investigators are critical for advancing medical knowledge, developing new treatments, and ensuring patient safety. The roadmap for investigators in clinical research is a comprehensive guide that outlines the steps and key considerations involved in conducting ethical and effective clinical trials. Investigating new therapies, drugs, or medical devices is a complex process, and following a well-defined roadmap is crucial for success. www.clinosol.com | follow us on social media @clinosolresearch 12 08 /25/2023

13. THE ROAD MAP FOR INVESTIGATORS 1. Research Objectives: Clearly outline the research objectives and questions you aim to address in clinical trial. Specify the primary and secondary endpoints that will measure the trial's success. 2. Protocol Development: Develop a detailed study protocol that includes the study design, eligibility criteria, treatment plan, and data collection methods. Ensure your protocol aligns with ethical principles, regulatory requirements, and scientific rigor. 3. Ethics Committee Approval: Submit your protocol to an ethics committee or Institutional Review Board (IRB) for ethical review and approval. Obtain informed consent forms and ensure participants fully understand the trial's risks and benefits. www.clinosol.com | follow us on social media @clinosolresearch 13 08 /25/2023

14. 4. Regulatory Submission: Prepare and submit regulatory documents to the appropriate regulatory authorities for approval (e.g., FDA in the United States, EMA in Europe). Collaborate with regulatory agencies to address any queries or requests for additional information. 5. Site Selection: Identify suitable clinical trial sites and investigators with relevant expertise. Ensure that site personnel are trained in Good Clinical Practice (GCP) guidelines. 6. Patient Recruitment: Develop a patient recruitment strategy to identify eligible participants. Implement effective recruitment and retention strategies to maintain an adequate study population . 7. Data Collection and Monitoring: Collect data according to the study protocol and monitor data quality. Ensure compliance with regulatory requirements and GCP guidelines. www.clinosol.com | follow us on social media @clinosolresearch 14 08 /25/2023

15. 8. Data Analysis: Analyze study data using appropriate statistical methods. Interpret results and draw conclusions regarding the investigational product's safety and efficacy . 9 . Reporting and Publication: Prepare and submit final study reports to regulatory agencies and ethics committees. Publish study results in peer-reviewed journals to contribute to scientific knowledge . 10. Post-Trial Follow-Up: Continue to monitor and report any long-term or late-onset adverse events. Collaborate with regulatory authorities to address any post-trial obligations or requirements. 08 /25/2023 www.clinosol.com | follow us on social media @ clinosolresearch 15

16. CONCLUSION T he Investigator's Brochure plays a pivotal role in the safe and ethical conduct of clinical trials. Its ability to consolidate and communicate vital information about investigational products contributes to the quality, transparency, and compliance of research activities, ultimately advancing the fields of medicine and healthcare . The roadmap provides a structured approach for investigators to navigate the complex terrain of clinical research. It emphasizes ethical conduct, compliance with regulations, and the generation of high-quality, scientifically sound data to contribute to advancements in healthcare. Adapt this roadmap to your specific research context and always prioritize patient safety and research integrity. 16 08 /25/2023 www.clinosol.com | follow us on social media @ clinosolresearch

17. REFERENCE Sievers , S., Wieschowski , S., & Strech , D. (2021). Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies.  British Journal of Clinical Pharmacology ,  87 (7), 2723-2731 . Rissmann , R., & Zuiker , R. (2021). Commentary on “Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies” by Sievers et al.  British Journal of Clinical Pharmacology ,  87 (7), 2633 . Schwenk , T. L., & Green, L. A. (2006). The Michigan clinical research collaboratory : following the NIH roadmap to the community.  The Annals of Family Medicine ,  4 ( suppl 1), S49-S54. 17 08 /25/2023 www.clinosol.com | follow us on social media @ clinosolresearch

18. Thank You! 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 18