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1 Music No audio Please review information shown to understand the general course navigation and available resources. Resources, such as the audio script, example forms, and website links, can be accessed at any time by selecting the Resources link found in the upper right corner. Also found in the upper right corner is a menu, which allows for quick navigation to pages within this program. On the bottom of the browser window, are tools to navigate the program. Course progress is identified by the blue and orange progress bar in the lower right corner. Lastly, throughout the course, there are orange flashing buttons. Selecting these buttons will provide additional information. Welcome to TransCelerate Investigator Oversight Informational Program. This is intended for a global audience to have general knowledge of Investigator oversight. You are to comply with both national and local requirements. Your responsibilities as an Investigator are to: protect the rights, safety and welfare of subjects participating in the clinical study personally supervise the conduct of the clinical study ensure the integrity of the collected and documented data comply with study protocol, applicable regulations, and Good Clinical Practice (GCP) The objective of this 45 minute program is to provide clarification of oversight responsibilities of the Investigator to conduct a successful clinical study through a series of real-life scenarios.

2 We will follow Dr. George Dimko, an Investigator who is new to clinical studies and is preparing to oversee a study under the guidance of his mentor, Dr. Laura Weeks. You will encounter them throughout this course as Dr. Weeks presents scenarios that you will need to help Dr. Dimko address. Through the examples, you will gain a deeper understanding on how to better manage study oversight. Like you, Dr. Dimko has committed to personally conduct and supervise a clinical study. He is aware of his responsibility as an Investigator to protect the welfare of the study subjects and ensure the integrity of the collected and documented data. You may have conducted other clinical studies in the past, but it's important to reflect on your past experiences and current responsibilities to ensure a successful clinical study. Continued awareness on proper oversight is critical. Dr. Dimko is ready for the challenge, are you? For the success of the clinical study it is critical that you and your clinical investigation staff comply with oversight obligations by regulatory authorities. There has been much scrutiny around Investigator oversight during recent inspection findings such as: inadequate Informed Consent process at the site insufficient documentation a lack of overall site compliance inadequate safety reporting study procedures not performed in compliance with the clinical protocol, and inadequate Investigational Product management This program will help you to better meet your responsibilities as an Investigator and equip you with the knowledge to be confident in performing study oversight activities. With so many regulations from various entities, it is clear why Investigator oversight can be challenging. Selecting the four regulatory agency images, will launch their respective website. Next, we'll take a look at some observations centered around Investigator oversight.

3 Failure to comply with regulations could result in government enforcement. The Investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the clinical study. This includes violations of tasks being performed by both the Investigator and delegated staff. Select the folder labeled "observations" to review examples of issues received by other Investigators. failure to personally conduct or supervise the clinical investigations failure to delegate tasks to appropriately qualified staff failure to maintain adequate and accurate records for disposition of the investigational drug failure to retain records required to be maintained by the clinical investigator failure to ensure that the investigation was conducted according to the investigational plan failure to take adequate precautions to prevent theft or diversion of an investigational drug that is subject to the Controlled Substances Act failure to maintain adequate and accurate case histories that record all observations and data pertinent to the investigation failure to provide requested Informed Consents, specifically most current version and signed copies for all subjects Is this information overwhelming? Well, follow Dr. Weeks as she provides information and explains why proper oversight is critical. Keeping in mind the regulatory inspection observations that Investigators have faced, it is critical you fully understand the importance of study oversight and how it relates to you. Some of the overall responsibilities of an Investigator related to study oversight may include: comply with protocol personally conduct or supervise investigations outlined in the protocol maintain control of Investigational Product [e.g., receipt, storage (temp logs), dispensing, return or destruction, and documentation]. obtain and document Informed Consent for each subject (or legal representative) throughout the study maintain adequate and accurate study records

4 ensure that Institutional Review Board (IRB) or Independent Ethics Committees (IEC) review and reporting requirements are met (initial and ongoing) ensure that IRB or IEC approval has been received before any study activities are performed (initial and protocol amendments) promptly report all changes in research activity and all unanticipated problems involving subject risk to the IRB/IEC and/or sponsor report adverse events and serious adverse events that occur in the course of the study to the sponsor, per timelines defined in the protocol ensure your understanding of the Investigational Product and the potential risks and benefits as outlined in the Investigator Brochure (IB) ensure that all associates, colleagues and employees assisting you in the study are qualified, trained, and appropriately delegated to perform assigned tasks comply with all other pertinent requirements outlined by all regulatory authorities Documentation is a key component in demonstrating proper oversight. Remember, if it is not documented, it did not happen. Therefore, it is highly recommended to document all information as soon as it occurs. Clear and concise communication between members of the study, such as the sponsor, site staff, subject, regulatory agencies, and third parties is an important component to achieve complete and compliant study results. Supervision is more than being a supervisor to direct reports. You are solely responsible to supervise all study activities to ensure subject safety. With your clinical study in mind, take time to reflect and ask yourself: Is all information documented as soon as it occurs? Do all my actions comply with regulatory requirements? Do my actions assure the safety and welfare of all clinical subjects? Do I fully understand all my responsibilities as an Investigator? This program will continue by highlighting key information pertaining to Investigator oversight and provide information and examples relating to some of the responsibilities of oversight an Investigator may have during a clinical study.

5 This unit will provide the structure needed to achieve successful supervision and oversight of the study. We will explain the importance of an Investigator s agreement to conduct and/or supervise a clinical study by adhering to study oversight best practices. For example, complete necessary steps before commencement of the study (e.g., identify and resolve pre-study gaps, delegate study related tasks, ensure appropriate training, and documentation) manage oversight of facilities, resources and staff to conduct study related activities manage oversight and appropriate delegation of tasks to qualified staff to conduct study activities and record documentation differentiate between delegation of study-related activities and retention of overall responsibility for those activities that have been delegated provide reasonable medical care and/or access necessitated by participants in a clinical study distribute required communications to sponsors, IRB/IEC, site staff and subjects Let s first take a look at what needs to be accomplished before Dr. Dimko can start his clinical study. Before performing any study-related activities, it is a best practice for Investigators to have an oversight plan including written processes, procedures, and tools to help manage the study. Some sites may have an established method in place to manage study-related activities. Ultimately, an oversight plan is to ensure the Investigator has adequate time and resources to oversee study activities. Such topics of an oversight plan could include: supervision of direct and ancillary staff and vendors delegation of tasks (While you are allowed to delegate tasks, you may not delegate oversight. Site staff must be authorized on the Delegation Log.) patient recruitment and informed consent process regulatory document management and IRB/IEC reporting study data and documentation including handling, storage and disaster planning safety data and adverse event assessment and reporting drug accountability, handling and storage

6 specimen collection and handling facilities and equipment management out of office process for planned or unexpected absences You are ultimately and solely accountable for the execution of the study at the site. Established processes or best practices provide you and your staff clear instruction to achieve both the sponsor and regulatory requirements. It is a best practice to establish processes and ensure your staff is trained for activities they are delegated. Let's follow Dr. Weeks as she mentors Dr. Dimko. Dr. Weeks: Just checking in, how are things going? Do you have any questions regarding your clinical study? Dr. Dimko: Things are going well, I am in the process of delegating study tasks to qualified staff. Dr. Weeks: Ok, what are some of the tasks you are delegating? Dr. Dimko: A variety of tasks, for example: physical exams, dispensing controlled substances, interpretation of lab results, data entry in Case Report Forms, and the assessments of X-rays and ECGs. Dr. Weeks: So, has the study staff received adequate training on how to conduct the delegated tasks and was the training documented? How do you know what training is required for the delegated tasks? Dr. Dimko: I m assigning the tasks based on medical training, licensing or certifications. For example, Cheryle is certified as an x-ray technician, so it makes sense to delegate that task to her. Dr. Weeks: Did you verify that her licensing was current? Dr. Dimko: Yes, and double checked that it was valid in accordance with the local laws. Dr. Weeks: A reminder, even though local law permits that she is qualified to perform the tasks, make sure your protocol doesn t have any additional qualifications. Dr. Dimko: Ok, good point. I will check the study protocol for specific qualifications to perform protocol required tasks. Dr. Weeks: How are you documenting the delegated tasks? Dr. Dimko: On the delegation log. Dr. Weeks: Great, because if it isn t documented it didn t happen. Dr. Dimko: Thanks for your help. Can you answer something else for me? I noticed in the protocol that I need to do physical exams and can t delegate this task, but in my practice I have the nurse practitioners perform those exams. I was planning to delegate to

7 them, that s ok, right? Dr. Weeks: No, don't forget that your responsibilities to your clinical practice are different from your responsibilities to the clinical study; you ll need to follow the protocol. All procedures performed on your clinical subjects need to adhere to the protocol. Dr. Dimko: Thanks for the information. Once I have trained the staff on the study purpose, relevant protocol details and product attributes in order to perform their delegated tasks, I will document the delegation. Many of you may have a process for documenting the completion of training. This can be captured either on a manual log or within an electronic tracking system. At a minimum, these methods must include date of training, type of training, trainers name and signature for instructor-led courses, a list of participants in attendance with their signatures, and version of material. The most important thing to remember is to document each training event as soon as it occurs. Select the orange button view an example of a Training Log used to document completed training pertaining to a clinical study. Good documentation is especially important when documenting delegated tasks. You have to: ensure you are delegating tasks based on medical training, licensing or certifications review licensing requirements ensuring they are current and valid in accordance with local laws and regulations, which may vary by state and country review the study protocol for specific qualifications to perform protocol-required tasks and clarify any questions related to delegation requirements with the sponsor follow protocol even if local laws permit individuals with different qualifications to perform the task Remember to always follow the most strict guidance. Some sponsors require you to confirm the proposed delegations at the site are acceptable. Let's follow Dr. Dimko as he continues his conversation with Dr. Weeks. Dr. Dimko: You mention documentation. How can I ensure I have good documentation? Dr. Weeks: Yes, documentation is extremely important. As I have said, if it is not documented, it did not happen. There are two things I

8 like to keep in mind when completing study related documentation. The first is ALCOA. Do you know what ALCOA stands for? Dr. Dimko: Oh yes, I know ALCOA, it is Attributable, Legible, Contemporaneous, Original, and Accurate. What does contemporaneous mean again? Dr. Weeks: You know, it is recording data as it is observed. For example, you need to ensure all the documents in the Investigator Site File are current and up to date. The other item I keep in mind when documenting is to always correct any errors; print, sign and date to ensure there is an audit trail. Dr. Dimko: These two things seem easy enough to understand and discuss with my study staff. Thanks. As seen during the conversation between Dr. Dimko and his mentor, it is common practice for investigators to delegate certain study-related tasks to employees, colleagues, or other third parties. It would be impossible to accurately recall each study staff member's unique qualifications, certifications, licenses and completed training during a regulatory inspection. However, creating a consolidated list will help both in the organization and collection of staff qualification documentation. The TransCelerate Site Signature and Delegation of Responsibilities Log can be found on the TransCelerate website, a link is provided in the Resources of this program. A list should be maintained which includes the information pertaining to the appropriately qualified persons delegated study-related tasks. At a minimum, the list should include the name of each person who is delegated a task, a description of the delegated tasks and identification of the range of dates for the involvement for each person, and include the start and end dates. It is also your responsibility to document any changes in study staff or delegation in a timely manner and perform periodic reviews to ensure accuracy. Select the orange button to view an example Delegation Log used to document delegated study-related tasks. Just like the delegation log, it is important to ensure study staff is appropriately trained and training is documented. Specifically, keep copies of materials used to train staff (e.g., slide decks or handouts). These training materials should include the approval date and version. make sure training materials cover the tasks staff members are required to perform. create a log to indicate the training attended including date and the training materials received by each staff member.

9 We will now follow Dr. Weeks, the mentor, as she reviews two scenarios related to activities Dr. Dimko may need to address. You will read her statement and select the choice that best matches the decisions Dr. Dimko should make. When overseeing a study, it is critical to ensure activities are complete and done in a timely manner, for example: addressing medical and ethical issues, including GCP issues that come to your attention addressing and correcting problems during study conduct related to IP accountability and adverse events, and reviewing the performance of a delegated task to verify the staff member's competency (e.g., independent verification of performance through repeated assessments) Let's review the responsibilities specific to activities performed during a study with five key members. You as the Investigator have responsibilities to the: Subjects IRB/IEC Site Staff Third Party and Sponsor Select each box to read a short description of your responsibilities according to ICH GCP and review examples demonstrating of oversight. There are a number of actions you can take to ensure your oversight plan will result in study success. Select each of the three example buttons to see Dr. Dimko interact with his study staff. I am certain he is equipped to handle all types of situations he may face during his day. Let's listen as Dr. Dimko demonstrates oversight through supervision during a staff meeting. Dr. Dimko: Did you all receive the protocol amendment A1, which

10 included the significant safety updates to our phase 3 study? All: Yes. Dr. Dimko: Great, Susie did you send the protocol amendment A1 and updated Informed Consent Form to the Ethics Committee? Susie: Yes, I sent them right away. Dr. Dimko: Have you received the approval from the Ethics Committee? Susie: Yes, I received them today. Dr. Dimko: And I assume you filed them as well. Susie: No, not yet. Dr. Dimko: Please file the IC and amendment and get the ongoing subjects in to be re-consented. We need to make sure that we document our discussion today and the decisions we made in the meeting minutes. We also need to send the approval to the sponsor. Dale: I just want to say thanks for scheduling these regular meetings. I find that documenting the discussions and decisions in the meeting minutes help keep us on track. Let's listen as Dr. Dimko demonstrates oversight by addressing an employee who is not complying with procedures. Dr. Dimko: Where are the lab reports for subject 110's visit that occurred 2 weeks ago? They have an appointment today and I need to review the reports. Sheri - I was waiting to provide the reports to you as a batch so it would save you time. Dr. Dimko- Labs should be reviewed in a timely manner. What if a result were abnormal and needed immediate care? It is important that I ensure the safety of my subjects. Sheri - I understand and will ensure these get to you as soon as they are received. Here is the information you need. Let's listen as Dr. Dimko demonstrates oversight when asked to share his password for delegated tasks. Dr. Dimko: I am heading out of the office. Don't forget that I delegated you to review and approve the Electronic Data Capture (EDC) data. Kelly: That's right, I remember. Before you leave, don't forget to

11 write down your password. Dr. Dimko: I can't share my password with you. Don't you have access to the EDC system already? Kelly: I did, but I am locked out of the system. Dr. Dimko: You need to call the Help Desk to have your password reset before I leave. Just a reminder, we can never share our passwords. This is unacceptable and against our policy. As you have learned in this unit, your responsibility as an Investigator includes supervision and oversight. Recognizing the importance of adhering to study oversight requirements will assure study success. We discussed require documentation, the process for delegating tasks, the importance of differentiating between delegation of studyrelated activities and overall responsibilities, and oversight of facilities, resources and staff. Take time to reflect on your own experiences to understand how these responsibilities will play a role during your clinical study. Consider asking yourself: Do I need to develop any written procedures or best practices? Am I delegating tasks to medically trained individuals with current and valid licenses and/or certifications, and in accordance to the study protocol and local laws, which ever is most strict. Do I differentiate between delegation of study-related activities and retention of overall responsibilities? In other words, do you and your study staff understand their responsibilities to the clinical study and to your private practice? Am I keeping copies of the materials used to train study staff and maintaining a log to capture the completion of training? Have I identified the correct staff and do they have the appropriate facilities and resources to perform their delegated tasks? Do I have an out of office procedure in place and do subjects have access to qualified individuals 24 hours a day? Am I following-up on actions and ensuring all key members receive up to date information. Ultimately, adhering to the best practices discussed during this unit will help assure the appropriate oversight and success of your clinical study. Select next to continue to the next unit which discusses

12 activities during study close-out and inspections. This unit will provide the structure needed to achieve successful supervision and oversight during close-out activities and be prepared for audits and inspections. You will: understand the continued responsibility to key team members after a study maintain an inspection ready status by retaining required records and essential documents to be accessed by regulatory authority inspectors and sponsor representatives or auditors distribute ICH GCP-required communications During close-out activities and to be prepared for audits and inspections, you as the Investigator have responsibilities to the: Subjects IRB/IEC Site Staff Third Party, and Sponsor Select each box to read a short description. You may be notified at any time of an inspection by either the Sponsor or a Regulatory Authority. It is critical to be available to respond to all requests. Inspections may be performed: to verify data that has been submitted to the regulatory authority for drug approval as a result of a complaint to the regulatory authority about the conduct of a study at the site in response to sponsor concerns or termination of a clinical site or related to certain classes of investigational products of special interest

13 If an inspection is scheduled, some of the areas of focus of the regulatory agency could include: Systems and Processes Processes and Protocol Training or Scientific/Medical Discussion So if Investigators are subject to enforcement for violations of government regulations and protocol requirements, including any tasks that are delegated to staff, why is it so important to document? The answer is simple, the information needs to be readily available to provide during audits and inspections in order to enable the investigator to demonstrate compliance with the applicable regulatory requirements. The detailed information will help ensure accuracy and consistent record documentation. Shown on the screen are a few additional examples of documentation. Let's summarize what we have reviewed during this last unit focused on close-out activities and audit preparedness as it relates Investigator oversight. Let's reflect by asking: Am I prepared for close-out activities and continued responsibilities that involve key members after a study? Am I prepared to address questions during audits and inspections? Do I have an inspection ready status by retaining required records and essential documents that may be accessed by regulatory authority inspectors? Do I continue distribution of ICH GCP-required communications? Keeping these questions in mind will assure continued study success during close-out activities. They will also provide direction to assure continued audit preparedness. Select next to continue to the Check for Understanding.

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