Explanation. ( ) The principal investigator is the entity charged with ensuring protocol compliance, not the IRB/IEC. (ICH 4.5.1)

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1 Question 1 Explanation ( ) The principal investigator is the entity charged with ensuring protocol compliance, not the IRB/IEC. (ICH 4.5.1) ( ) According to ICH GCP an IRB/IEC should safeguard the rights, safety, and well being of all trial subjects. The IRB/IEC review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. (ICH 3.1.1) ( ) An IRB is charged with protecting the rights, safety and wellbeing of trial subjects. There is no responsibility for ensuring participation. (ICH 3.1.1) ( ) An IRB/IEC reviews Informed Consent Forms in order to ensure adequate information is provided to subjects. This is a tool for ensuring patient rights safety and well-being. Question 2 ( ) According to CFR 50.25, the first basic element is: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. ( ) The basic elements require a description of any reasonably foreseeable risks or discomforts to the subject. Additional elements enumerate that a treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. ( ) The 4 th basic element is a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. ( ) The 7 th basic element required in an informed consent is an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a researchrelated injury to the subject. Question 3 ( ) The Kefauver-Harris Amendment is a U.S. document enacted to strengthen the FDA in regard to clinical trials and human subject protection. ( ) The Nuremburg Code is the summary ofpermissible human experiments that was never incorporated into law or regulation.

2 ( ) GCP is based on the thirteen points of the Declaration of Helsinki. ( ) The International Conference on Harmonisation formulated the GCP guidelines that are based on the Declaration of Helsinki. Question 4 ( ) False ICH GCP is a guideline, not a law. It works within the boundaries of local law. Local law supercedes the guidelines. Question 5 ( ) A qualified physician must oversee the medical decisions of the subjects. (ICH 4.3.1) ( ) Individuals involved in the conduct of the trial must be qualified through training or education for the tasks involved. (ICH 2.8) ( ) The sponsor can train some trial related tasks. Others must be designated based on local and educational requirements. (ICH 2.8) ( ) Principal #8 of GCP states, Each individual involved in conducting a trial should be qualified by education, training and experience to conduct or perform the respective task. (ICH 2.8) Question 6 ( ) Individual members with special expertise may be invited to participate in discussions, but they will not be voting members. (ICH 3.2.6) ( ) Only members who are independent of the investigator and the sponsor should vote/provide opinion on trial related matters (ICH3.2.1) ( ) Recommended that one member is expert in a non-scientific area (ICH b) ( ) At least 5 members (ICH a) Question 7 ( ) The investigator may implement a deviation from, or a change in, the protocol to eliminate an immediate hazard to trial subjects without prior IRB/IEC approval. ( ICH 4.5.4) ( ) The investigator should not implement any deviation from, or changes of the protocol except where necessary to eliminate an immediate hazard to trial subjects. (ICH 4.5.2) ( ) The investigator/institution should conduct the trial in compliance with the

3 protocol agreed to by the sponsor The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm the agreement. (ICH 4.5.1) Many IRB/IECs have an institutional representative to confirm institutional ability to comply prior to approval. ( ) Correct answer is A Question 8 ( ) False. IRB procedures should specify that no subject should be admitted to a trial before the IRB/IEC issues its written approval of the trial (ICH 3.3.6). Question 9 ( ) A duly constituted IRB has reviewed and approved the investigational product protocol without an informed consent. (CFR Section d) ( ) The subject is in a life-threatening situation and the risks are reasonable in relation to the medical condition. (CFR Section iii). ( ) If immediate use of the test article is required to preserve the life and time is not sufficient to obtain legal representative permission, and all other criteria of approval have been satisfied, the waiver may be implemented. (CFR 50.23, sections 2 and 3). ( ) If immediate use of the test article is (opinion) required to preserve the life of the subject and time is not sufficient to obtain consent, and all others have been satisfied, the article may be used and documentation will be provided at a later time. (CFR section b). Question 10 ( ) False. Research participants are randomized in clinical trials so that bias does not weaken the study results. The chance of a subject receiving Investigational Product is based on protocol design, not randomization. Question 11 ( ) Treating the adverse event means stopping the investigational therapy (if applicable) and treating any symptoms or sequellae. Breaking the blind is not necessary unless it might change the therapy. ( ) Most informed consents specifically state that even if a patient withdraws from the trial, the blind will not be broken. Only when the safety profile can be altered by breaking the blind, should the patient designation be revealed. ( ) Unblinding is not done until all statistical tests have been completed. Persons responsible for analysis and interpretation of results should maintain the blind

4 until all testing is complete. (ICH E2A Section D) ( ) When a patient s treatment might change based on knowing the treatment assignment, the need to know overcomes the need to minimize bias. Question 12 ( ) The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor, which was given approval by the IRB. (ICH 4.5.1). ( ) The investigator should have available an adequate number of qualified staff and adequate facilities to conduct the trial safely and properly. (ICH 4.2.3) ( ) The sponsor should expedite the reporting to all concerned and to the regulatory authorities of all ADRs. (ICH 5.17). ( ) During and following subject participation, the investigator should ensure that adequate medical care is provided to a subject for any adverse events. (ICH 4.3.2) Question 13 ( ) Sponsor is responsible for written SOPs to ensure that trials are conducted and data are generated in accordance with the protocol (ICH 5.1.1) ( ) Prior to entering an agreement with the investigator, the sponsor should provide the investigator with the protocol and an up-to-date Investigator Brochure (ICH 5.6.2) ( ) Providing adequate medical care is an investigator responsibility (ICH 4.3.1) ( ) The sponsor is responsible for ongoing safety evaluation of the investigational product(s). (ICH 5.16) Question 14 ( ) Summary of findings from non-clinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial. (ICH 6.2.2) Only including positive trials does not follow the guidelines. ( ) Description of the population to be studied. (ICH 6.2.6) ( ) A detailed description of the objectives and the purpose of the trial. (ICH 6.3) A detailed description of the trial design that should include endpoints and other pertinent descriptions. (ICH 6.4) ( ) A statement that the trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements. (ICH 6.2.5)

5 Question 15 ( ) False The guidance does not bind the FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both. (Introduction E6 GCP Guidance)