Systems to ensure quality are implemented in all aspects of the trial.
The PI is responsible for the conduct of the trial, however, "CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol." The CRC's primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. Although not inclusive, some of the CRC responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations, developing a detailed cost analysis, negotiating the budget with the Sponsor, subject recruitment, patient care, adverse event reporting, preparing the case report form, submitting CRFs and other data to the Sponsor as necessary and study close-out.
Responsibilities
Feasibility
A sponsor sends a feasibility questionnaire to the local research site. The Clinical Research Coordinator completes the form on behalf of the site to determine if the local site has the patient population, support staff, medical facilities, and equipment necessary to successfully carry out the study protocol.
Institutional Review Board submissions
All research involving human subjects must be approved by an Institutional Review Board. Each IRB has protocol submission requirements, which typically involve an IRB application and informed consent document. A study cannot begin without IRB approval.
The IRB must approve informed consent prior to study initiation, and often the CRC is liaison between the IRB and the sponsor. The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a:
Statement that the study involves research, an explanation of research purpose, expected duration of subject's participation, description of procedures, and identification of any experimental procedures
Description of any reasonably foreseeable risk or discomfort to the subject
Description of any benefits to the subject or others that can reasonably be expected
Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Statement that describes extent, if any, to which confidentiality subject identity is maintained
Explanation as to any compensation, medical treatments available if injury occurs and, or where further information is available
List of whom to contact for pertinent questions about the research and subjects' rights, and whom to contact in the event of a research-related injury to the subject
Statement that participation is voluntary, refusal to participate involves no penalty or loss of benefits, and that the subject may discontinue participation at any time without penalty or loss of benefits
Additional elements
When appropriate, experimenters also tell each subject:
That the particular treatment or procedure may involve unforeseeable risks to the subject
Circumstances under which investigator may end subject's participation without subject's consent
Additional costs to the subject that may result from participation in the research
Consequences of subject withdrawing from the research, and procedures for orderly termination of subject participation
That significant new findings during the research that could affect the subject's willingness to continue participation will be provided to the subject
The approximate number of subjects involved in the study
Contracting with pharmaceutical companies
The site conducting the clinical trial negotiates the clinical trial agreement to conform to its policies and procedures. The resolution of many contractual issues requires coordination between the sponsor, the PI and the site, which is usually the responsibility of the CRC. The involvement of each party is essential to a successful CTA with mutually acceptable terms. The CTA should include terms for indemnification, confidentiality, publication, intellectual property, insurance, data safety and monitoring boards, subject injury, governing law and termination clauses.
Cost analysis and budget negotiations
To develop a cost analysis, the CRC reviews the protocol schema and determine which procedures are standard of care, versus research. Research charges are included in the budget—with personnel effort, site initiation costs, IRB fees throughout the life of the clinical trial, pharmacy costs, travel costs for the PI and CRC to attend investigator meetings, equipment, dedicated fax and computer lines, supplies, screen failures, subject stipends, subject travel costs, and any other items defined as a direct cost to the clinical trial. In addition, if the clinical trial is at an Academic Medical Center, an indirect cost rate applies to the direct study costs. The indirect rate is approximately 30% for pharmaceutical trials, and can be upwards of 50% for federal trials, depending on the AMC's federally negotiated indirect costs rate .
Subject recruitment
Prior to agreeing to conduct the clinical trial, the CRC determine if they have the appropriate patient population. The CRC is responsible for subject recruitment once the trial begins, or must establish the research team that recruits subjects. Viable subject recruitment must occur beforehand, as the clinical trial agreement stipulates the number of subjects the site must recruit.
Patient care
The CRC coordinates and conduct patient care visits and assures that all procedures comply with the protocol. The CRC interacts with the PI to assure the patient receives appropriate medical evaluation and care when needed and alerts the PI of any serious adverse events that occur during the study.
Adverse events
An adverse event is described as "any adverse change in health or "side-effect" that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a pre-specified period of time after their treatment has been completed." The CRC must report all adverse events to the sponsor and all serious adverse events to the IRB and sponsor.
The purpose of the case report form is to collect relevant data in accordance with the protocol and in compliance with regulatory requirements. The CRC collects the data on the CRF and submit to the sponsor either electronically or paper format.
Electronic Data Capture
The electronic data capture is an online database where the information collected on the Case Report forms, or source documents is entered. These are usually created by the study sponsor or their subcontractors.
Processing and shipping of laboratory samples
Many Clinical Trials and non-clinical research studies use laboratory assessments/samples to assess patient response and or Adverse Events. The CRC is frequently responsible for the basic laboratory preparation of labs samples such as making hematology slides, spinning and aliquoting blood samples or placing tissue in formalin or flash freezing. These blood or tissue samples may be analyzed locally or sent to central laboratories for processing and analysis. The CRC must abide by The International Air and Transportation Association regulations for biologic sample shipments.
Study close
In accordance with the local IRB, the CRC completes IRB study close documentation and appropriately notifies study subjects, research team, and pharmacies. The CRC works with the sponsor's clinical monitor to complete outstanding monitoring findings and queries. In addition, the CRC must comply with record retention policies of the Food and Drug Administration, the ICH, and the clinical trial agreement.
