1.1. Sponsor A sponsor can be an individual, such as a physician, or an organization, such as a pharmaceutical company, an academic center, or a government agency such as an institute or a center within the National Institutes of Health (NIH). For some studies, the sponsor may provide financial support; however, in general the sponsor is responsible for the following activities: Selection of qualified investigators Verification that regulatory issues are met Submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA) Monitoring the study to verify that it is being conducted according to the approved protocol Informing investigators at all sites of significant new adverse events Reporting of serious adverse events to the FDA 1.2. Principal Investigator The principal investigator (PI) is usually the author of the protocol document and is the person who is primarily responsible for ensuring that the trial is conducted according to good clinical practices. The investigator signs the Statement of the Investigator, FDA Form 1572, which is an agreement to comply with FDA regulations in the use of the investigational agent. In addition, the PI also agrees to conduct the trial according to the written protocol, obtain approval of the institutional review board (IRB) prior to initiating the trial and at any time the protocol is amended, maintain adequate records of the trial, protect subjects through the informed consent process,and notify the sponsor and the LRB of adverse events. Although the investigator can delegate authority to other members of the team to perform various func- tions, the ultimate responsibility for the study cannot be delegated. ‘Lhe 1 has the final responsibility for the conduct of the trial and must instruct all members of the research team of their responsibilities in the conduct of the trial 1.3. Coinvestigators/Associate Investigators/Subinvestigators ‘There are several additional members of the research team, including other physician-investigators, clinical trial nurses, data managers, statisticians, pharmacists, bioethicists, and social workers. In addition, for mul- ticenter trials, a PL at a clinical site may also be consid- ered an integral member of the team. It is important to document which individuals listed as members of the research team have responsibility for patient care. Each physician-investigator having responsibility for patient care must file a FDA Form 1572 with the sponsor. In addition, they might also obtain informed consent, order investigational agent, and monitor study participants for adverse events. 1.4. Study Coordinator or Clinical Trial Nurse The study coordinator is often a nurse with a bac- calaureate or master’s degree with experience in clini- cal trial management. With the advent of computerized systems for clinical trial management, coordinators should also have experience with automated systems. The study coordinator usually is responsible for the following activities Provide education for the research team and other staff about the general conduct of clinical trials and training for specific trials at the site Provide education for the participant and family to help with the decision to participate in the clinical trial and to assist with care during the continuum. of the trial Check eligibility criteria Arrange for study tests Collect results of these tests. ‘The clinical trial nurse (CTN) monitors the partici- pant's use of the investigational agent and interviews the participant about possible adverse event experi- ences. The CTN might also be responsible for drawing pharmacokinetic samples.6. INFORMED CONSENT Informed consent is a process that should be fol- lowed prior to requesting the signature from the participant and may begin before the participant is designated as eligible for the study. The process of informed consent includes an explanation of the research study to the participant, a discussion of the participant’s review of the consent document, and a time for questions and answers. Once the initial component of the process has been completed, the last phase in the process is the request for the participant's signature and date of signing. The consent document is then witnessed by the investiga- tor and additional witnesses as required by the SOPs of the sponsor or the site. The informed consent process is then documented in the patient’s medical record. The study participant should also receive a copy of the consent document. Table 7-2 lists the essential require- ments of the consent document. If the informed consent document is amended later in the study, the patient should be re-consented. The informed consent process is again initiated to explain the reasons for the new consent. Both the original and any additional consent documents that the patient has signed should be kept in the research record and a copy placed in the medical record.Basic Elements of Informed Consent 45 CFR 46.116 (a) ‘The following information shal be provided to each subject: ‘A statement thatthe study involves research, an explanation ofthe purposes of the research and the expected duration ofthe subjec’s ‘participation, a description of the procedures to be followed, and identification of any procedures that ate experimental, ‘A description of any reasonably foreseeable risks or discomforts tothe subject. ‘A description of any benefits to the subject or to athers that may reasonably be expected from the research A disclosure of appropriate altemative procedures or courses of treatment, if any, that might be advantageous to the subject ‘A statement describing the extent, if any, #o which confidentiality of records identifying the subject willbe maintained. For research involving mote than minimal rsk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are availabe if injury occurs and, if 0, what they consist of or where further information may be obtained 7. An explanation of whom to contact fer answers to pertinent questions about the research and research subjects’ rights, and whom to contac in the event of a research-rlated injury tothe subject. '8 Astatement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is ‘otherwise entitled, and the subject may discontinue participation at anytime without penalty or loss of benefits to which the subject is ‘otherwise entitled,