Ophthalmic Research Training Services

The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (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 as:

• All clinical research trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
  
  
• Benefits outweigh risks for each patient.
  
  
• Rights, safety and well-being of patients prevail over science.
  
  
• All available non-clinical and clinical information on any investigational agent can support the trial as designed.
  
  
• All trials are scientifically sound and clearly described.
  
  
• All clinical research trials have current Institutional Review Board approval.
  
  
• Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
  
  
• Everyone involved in the clinical research trial is qualified by training, education and experience.
  
  
• Informed consent is given freely by every participant.
  
  
• All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
  
  
• Confidentiality of subjects is respected and protected.
  
  
• Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
  
  
• Systems to ensure quality are implemented in all aspects of the clinical research trial.

Although the Principal Investigator (PI) is responsible for the conduct of the trial, "it has been said that the Clinical Research Coordinator (CRC) is the heart and soul of the clinical research study and that, ultimately, it is the Clinical Research Coordinator (CRC) who carries forward the research goals, thereby playing a significant role in the success of the clinical research study. Most importantly, 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 Clinical Research Coordinator's (CRCs) 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 (i.e. pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

All clinical 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.

The IRB must approve the informed consent prior to study initiation and often the Clinical Research Coordinator (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 Clinical Research Coordinator (CRC) is responsible for the communication between the IRB and the sponsor.

The site conducting the clinical research trial will negotiate the clinical trial agreement (CTA) to conform to its policies and procedures. The resolution of many contractual issues requires coordination between the sponsor, the Principal Investigator (PI) and the site, which is usually responsibility of the Clinical Research Coordinator (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.

To develop a cost analysis, the Clinical Research Coordinator (CRC) will review the protocol schema and determine which procedures are standard of care versus research. The research charges will be included in the budget along with personnel effort, site initiation costs, IRB fees throughout the life of the clinical research 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 that are defined as a direct cost to the clinical trial. In addition, if the clinical research trial is conducted at an Academic Medical Center (AMC) there will be an indirect cost rate that will be applied to the direct costs of the study. 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.

Prior to agreeing to conduct the clinical trial, the Clinical Research Coordinator (CRC) (and the PI) will determine if they have the appropriate patient population. The CRC is responsible for subject recruitment once the clinical research trial begins or establishing the research team that will recruit subjects. It is important that viable subject recruitment occurs beforehand as the clinical research trial agreement will stipulate the number of subjects the site is required to recruit.

The Clinical Research Coordinator (CRC) will coordinate and conduct patient care visits and assure all procedures are conducted in compliance 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.

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 (study medication, application of the study device, etc.) or within a pre-specified period of time after their treatment has been completed." The Clinical Research Coordinator (CRC) must report all adverse events to the sponsor and all serious adverse events to the IRB and sponsor.

In accordance with the local IRB, the Clinical Research Coordinator (CRC) will complete IRB study close documentation and make any appropriate notifications to the study subjects, research team, and pharmacies. The Clinical Research Coordinator will work with the sponsor's clinical monitor in completing outstanding monitoring findings and queries. In addition, the CRC is responsible form complying with the record retention policies of the Food and Drug Administration (FDA), the ICH, and the clinical trial agreement.

There are two organizations that provide certification for Clinical Research Coordinators: Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA). ACRP offers the designation of Certified Clinical Research Coordinator 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 community."