Investigator's Brochure - The Road Map for Investigators

The Investigator's Brochure (IB) is a crucial document in the early stages of clinical drug development. It serves as a comprehensive and detailed source of information about the investigational product and provides a roadmap for investigators involved in a clinical trial. Here's an overview of the key components and significance of the Investigator's Brochure

1. Welcome Investigator’s brochure – The Road Map for Investigators Dr Ummera Banu Doctor of Pharmacy CSRPL_STD_IND_HYD_ONL/CLS_226/112023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Investigator’s Brochure Investigator's Brochure  ( IB ) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a  drug trial . The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2

3. An IB may introduce key aspects and safety measures of a  clinical trial protocol , such as: Dose (of the study drug) Frequency of dosing interval Methods of administration Safety monitoring procedures 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3

4. Contents An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.  10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Contents of IB. The investigator Brochure should include Title Page Sponsor Name The identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible & desired by the sponsor. The release date. Confidentiality statement. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Responsibility The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6

7. The  Investigator’s Brochure  ( IB ) is given to clinicians,  investigators , and other healthcare professionals involved in the conduct of  clinical trials  (for instance, the  clinical trial  coordinators and study nurses).  10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7

8. The  IB  is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising the information on an  investigational medicinal product . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

9.  It provides the clinician or potential  investigator  with the information they need to assess the appropriateness of a trial, including the  benefit - risk  ratio, in an independent and unbiased way. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9

10. The  IB  must include for each  investigational medicinal product : Information on the  sponsor ’s name and the identity of the product (research number,  generic  and trade names). A confidentiality statement with instructions to treat the document as confidential and for the exclusive use of the  investigator ’s team, review boards, and  ethics committees . A compilation of results gathered from non-clinical and  clinical studies  of the medicine. Background information on the properties and history of the  investigational medicinal product . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10

11. IB Regulatory An  IB  is submitted to the regulatory authorities along with the  Clinical Trial Application  ( CTA ), and regulatory authorities also review any updates to the  IB  to ensure that it is accurate, complete, and impartial. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11

12. The information should be presented in a short, simple objective, and non-promotional form that enables a clinician or potential investigator to understand it. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12

13. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13