GCP Training Quiz For Clinical Research Professionals

The correct answer is "All of the above" because all three items mentioned - timeliness, being responsive and persistent, and only performing tasks that one is licensed or trained to do - are important qualities that define a successful clinical research professional. Being timely ensures that deadlines are met and projects progress smoothly. Being responsive and persistent helps in effectively communicating and following up on tasks. And only performing tasks that one is licensed or trained to do ensures compliance with regulations and maintains the integrity of the research process.

According to ICH guidelines, it is recommended for the investigator to inform a study participant's primary care physician if the subject agrees to this notification. This ensures that the participant's primary healthcare provider is aware of their involvement in the study, allowing for better coordination of care and monitoring of any potential effects or interactions with the study intervention.

In this study, the FDA will review the original clinic chart in addition to the source document worksheets. This is done to ensure the validity of the study data. The source document worksheets may provide some information, but the FDA wants to further evaluate the data by referring to the original clinic chart. Therefore, the statement is true.

A phase III trial is the final stage of clinical trials before a drug can be approved for public use. During this phase, the drug is tested on a large number of participants to determine its effectiveness in treating the specific condition it is intended for. The purpose of this trial is to gather enough evidence to confirm whether the drug is indeed effective in treating the targeted condition. Therefore, the statement that the purpose of a phase III trial is to evaluate whether a drug treats the condition it is expected to treat is true.

The correct answer is "Adverse event, since the complaint is more frequent." This is because the subject's headaches have become more frequent since starting the study, which indicates a change in their condition. Even though the headaches have been present for years, the increase in frequency is considered an adverse event and should be reported.

Research studies are designed to investigate the effectiveness of potential treatments, interventions, or therapies for various conditions. However, it is important for research professionals to distinguish study participation from actual treatment. This is because participating in a study does not guarantee that the patient will receive the intended treatment or experience the desired outcome. Instead, the purpose of the study is to gather data and evaluate the effectiveness of the treatment being tested. Therefore, it is critical for research professionals to communicate to patients that study participation is not typically considered as a form of treatment.

When a subject participating in a study dies, it is important for the sponsor to report this to the FDA within 24 hours. This is crucial for ensuring the safety and ethical considerations of the study. Reporting the death allows the FDA to assess any potential risks or factors that may have contributed to the subject's death, ensuring that appropriate actions can be taken to protect the well-being of other participants. Therefore, the statement is true.

A source document is the term routinely used to describe any location where original data is recorded. This document serves as evidence of the information collected during a study or research. It is considered the primary record and is used to verify the accuracy and authenticity of the data. Source documents can include medical records, laboratory reports, questionnaires, and other forms of documentation that contain the original data.

Pneumonia is reported as a Serious Adverse Event (SAE) because it meets the criteria of prolonging hospitalization. The subject's development of pneumonia resulted in an extended stay in the hospital, which is considered a serious outcome. Therefore, it is necessary to report it as an SAE in order to document and monitor any potential adverse effects of the study.

The statement suggests that when a SMO (Site Management Organization) is involved in a study, they take ultimate responsibility for the study's conduct, relieving the investigator of this burden. However, the correct answer is false. While SMOs can provide support and assistance in managing the study, the ultimate responsibility for conducting the study lies with the investigator. The SMO's role is to facilitate and streamline the study process, but they do not remove the burden of responsibility from the investigator.

The PI, or Principal Investigator, is the individual with ultimate responsibility for local study conduct according to FDA and ICH guidelines. The PI is typically a qualified physician or researcher who oversees the entire study, including the recruitment and enrollment of participants, data collection and analysis, and ensuring compliance with regulatory requirements. They are responsible for the overall conduct and management of the study at the local site.

This is most likely a phase III trial because phase III trials involve large numbers of participants (in this case, 4000 subjects) and are conducted to evaluate the effectiveness of a new drug. Phase I trials are typically small and focused on safety, phase II trials involve a larger number of participants to assess efficacy and side effects, and phase IV trials are conducted after the drug has been approved and are focused on long-term safety and effectiveness.

Per the FDA Regulations, the Institutional Review Board (IRB) is required to conduct continuing review of protocols on an annual basis. This means that the IRB must review and evaluate the progress of ongoing research studies at least once every year to ensure that the rights and welfare of human subjects are protected and that the study is still scientifically valid. This requirement helps to ensure that research studies are conducted ethically and that any potential risks to participants are minimized.

According to FDA regulations, a sub-investigator does not have to be a physician. This means that individuals who are not physicians can also be sub-investigators. Therefore, the given statement is false.

The FDA Form 1572 is a regulatory document that outlines the individual commitments of the Principal Investigator (PI) in drug studies regulated by the FDA. It is a crucial document that provides information about the qualifications and responsibilities of the PI, including their agreement to follow the protocol, comply with regulations, and report any adverse events or changes in the study. This form helps ensure that the PI understands and agrees to their obligations in conducting the study in accordance with FDA regulations.

According to FDA regulations, the sponsor of a study is responsible for interacting with the Institutional Review Board (IRB) to ensure the protection of human subjects. This means that the sponsor is responsible for coordinating and communicating with the IRB regarding the study design, informed consent process, and any potential risks or benefits to the participants. The sponsor plays a crucial role in ensuring that the study is conducted ethically and in compliance with regulatory requirements. Therefore, the statement "True" is correct.

In this example, the sticky-note is considered to be the source document. This is because the blood pressure measurements are initially written on the sticky-note as they are being taken, making it the original record of the data. The sticky-note serves as the immediate source of information before it is transcribed into other documents such as the clinical chart and the CRF.

The correct answer is ICH Guidelines. The International Council for Harmonisation (ICH) developed guidelines to standardize the conduct of clinical studies and ensure that they meet regulatory requirements across different countries. By following these guidelines, researchers can avoid the need to repeat studies in each country, saving time and resources. These guidelines cover various aspects of study conduct, including ethical considerations, data management, safety reporting, and regulatory submissions.

The main purpose of an IRB (Institutional Review Board) is not to ensure the accuracy of data submitted to the FDA. Instead, the primary role of an IRB is to protect the rights and welfare of human research participants. IRBs review research protocols to ensure that they are ethical, comply with regulatory requirements, and minimize potential risks to participants. They also oversee the informed consent process and monitor ongoing research activities to ensure participant safety. Therefore, the given statement is false.

False. An IRB (Institutional Review Board) is required to review studies involving human subjects under both FDA (Food and Drug Administration) regulations and HHS (Department of Health and Human Services) regulations. The IRB ensures that the rights and welfare of human subjects are protected in research studies.

Utilizing another IRB to review studies is only allowed when this process is pre-approved by the local IRB. This means that the strict IRB at the institution must give permission for the use of another IRB. This ensures that all institutional requirements and ethical considerations are still met, even if an external IRB is involved in the review process.

The correct answer states that in this situation, the physician can prescribe the medication for off-label use as deemed appropriate. Off-label use refers to the use of an approved drug for a condition or patient population that is not specifically listed in the drug's package insert. In such cases, physicians have the discretion to prescribe medications based on their clinical judgment and knowledge of the patient's condition, even if it is not explicitly approved by the FDA for that particular use. This allows for flexibility in treatment options and enables physicians to tailor therapies to individual patient needs.

FDA Form 1572 is a document that investigators participating in clinical trials must complete. It outlines various agreements and responsibilities of the investigator. The agreement to medically evaluate the usefulness of the study drug is not specifically mentioned on FDA Form 1572. This agreement falls under the general responsibility of the investigator to conduct the study in accordance with good clinical practices and to ensure the safety and welfare of the study participants. However, it is not explicitly outlined as a separate agreement on the form.

Medical school students, cognitively-impaired individuals, and prisoners may represent a special population that requires additional oversight in terms of human subject protection. Medical school students may be considered vulnerable due to their limited experience and power dynamics within the medical field. Cognitively-impaired individuals may have difficulty understanding the risks and benefits of participating in research, requiring extra safeguards to protect their rights and well-being. Prisoners may also be vulnerable due to their restricted autonomy and potential coercion. Therefore, the correct answer is B & C, indicating that both cognitively-impaired individuals and prisoners may require additional oversight in human subject protection.

The statement is false because the requirement for appropriate IRB review of clinical research involving humans is not limited to the approval of the IRB chairman and one other scientific member of the committee. In fact, IRB review typically involves the evaluation and approval of the entire committee, which consists of various members with diverse expertise and backgrounds. This ensures a comprehensive and well-informed review process to protect the rights and welfare of human research participants.

The statement suggests that only 1 out of every 25 compounds studied in the drug development process makes it into preclinical testing. However, the correct answer is False. This means that the statement is not accurate. It implies that more than 1 in 25 compounds are studied and proceed to preclinical testing during the drug development process.

The correct answer is 21 CRF part 56. This part of the Code of Federal Regulations specifically pertains to Institutional Review Boards (IRBs) and provides the regulations governing the policy, procedure, and process of IRBs. It outlines the requirements for the composition, responsibilities, and functions of IRBs, as well as the criteria for IRB approval of research protocols. Therefore, if an investigator wants to find the regulations that govern the IRB, they should reference 21 CRF part 56.

The FDA requirement for source documents and CRF storage is 5 years after an NDA is submitted or IND withdrawn. This means that the FDA mandates that these documents must be retained and kept accessible for a period of 5 years after the submission of a New Drug Application (NDA) or after an Investigational New Drug (IND) is withdrawn. This is important for ensuring the availability of relevant information for regulatory purposes and potential audits or inspections.

The recent industry reports suggest that the cost to develop and bring one drug to the marketplace is estimated to be around 800 million dollars. This indicates that the process of drug development involves significant financial investment. The high cost can be attributed to various factors such as research and development, clinical trials, regulatory approvals, manufacturing, and marketing. These expenses highlight the complexity and rigorous nature of the drug development process, which requires substantial resources to ensure safety, efficacy, and compliance with regulatory standards.

The Investigator would need to disclose their interest in the pharmaceutical company if they have $75,000 worth of stock in that company. This is a significant financial interest that could potentially bias their decisions and actions during the study. Therefore, it is important for transparency and to ensure the integrity of the study that this information is disclosed.