【正文】 utical trials and can be upwards of 50% for federal trials, depending on the AMC’s federally negotiated indirect costs rate [4].Subject recruitmentPrior to agreeing to conduct the clinical trial, the CRC (and the PI) will determine if they have the appropriate patient population. The CRC is responsible for subject recruitment once the trial begins or establishing the research team that will recruit subjects. It is important that viable subject recruitment occurs beforehand as the clinical trial agreement will stipulate the number of subjects the site is required to recruit.Patient careThe CRC will coordinate and conduct patient care visits and assure all procedures are conducted in pliance with the protocol. The CRC will interact with the PI to assure patient receives appropriate medical evaluation and care when needed and will alert the PI of any serious adverse events that may occur throughout the course of the study.Adverse eventsMain Article: Adverse eventAn adverse event is described as “any adverse change in health or sideeffect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a prespecified period of time after their treatment has been pleted.” The CRC must report all adverse events to the sponsor and all serious adverse events to the IRB and sponsor.Preparing and submitting case report formsMain Article: Case report formThe purpose of the case report form (CRF) is to collect relevant data in accordance with the protocol and in pliance with regulatory requirements. The CRC will collect the data on the CRF and submit to the sponsor either electronically or paper format.Study closeIn accordance with the local IRB, the CRC will plete IRB study close documentation and make any appropriate notifications to the study subjects, research team, and pharmacies. The CRC will work with the sponsor’s clinical monitor in pleting outstanding monitoring findings and queries. In addition, the CRC is responsible form plying with the record retention policies of the Food and Drug Administration (FDA), the ICH, and the clinical trial agreement.Clinical research coordinator certificationThere are two organizations that provide certification for the CRCs: Association of Clinical Research Professionals [5] (ACRP) and the Society of Clinical Research Associates [6] (SoCRA). ACRP offers the only accredited* CRC designation in the field, the Certified Clinical Research Coordinator (CCRC174。4. The consequences of a subject39。2. Anticipated circumstances under which the subject39。6. For research involving more than minimal risk, an explanation as to whether any pensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained。2. A description of any reasonably foreseeable risks or disforts to the subject。 4 External links Basic elements of informed consent167。 Confidentiality of subjects is respected and protected. Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists. Rights, safety and wellbeing of patients prevail over science.Clinical research coordinatorThe Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of the Principal Investigator (PI). Good Clinical Practices Principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [1] as: All available nonclinical and clinical information on any investigational agent can support the trial as designed. Everyone involved in the clinical trial is qualified by training, education and experience. Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling. Additional elements of informed consent.o Contracting with pharmaceutical panieso Cost analysis and budget negotiationso Subject recruitmento Patient careo Adverse eventso Preparing and submitting case report formso Study close 5 ReferencesClinical research coordinator responsibilitiesInstitutional Review Board submissionsFor more details on this topic, see Institutional Review Board.All research involving human subjects must be approved by an Institutional Review Board. Each IRB has requirements for protocol submissions which usually require the preparation of an IRB application and informed consent document. A study cannot begin unless IRB approval is obtained.Informed consentThe IRB must approve the informed consent prior to study initiation and often the CRC is liaison between the IRB and the sponsor. The sponsor will have set requirements of the informed consent as does the IRB. Each local IRB is responsible for the review and approval of the informed consent, but the CRC is responsible for the munication between the IRB and the sponsor. 167。3. A description of any benefits to the subject or to others which may reasonably be expected from the research。7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects39。s participation may be terminated by the investigator without regard to the subject39。s decision to withdraw from the research and procedures for orderly termination of participation by the subject。) and SoCRA offers the designation of Certified Clinical Research Professional. SoCRA established the Certification Program for Clinical Research Professionals in order to “create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the medical research munity.” By performing these duties, the CRC works with the PI, department, sponsor, and in