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Standard operating procedures for clinical research coordinators
Fries, Ruth AnnClinical research coordinators are specially trained professionals who oversee and manageresearch trials, ensuring that rigorous standards of the Food and Drug Administration, Office of Human Research Protection, and industry are met. Standard operating procedure manuals arerapidly becoming an industry requirement. Although developing a comprehensive manual isdemanding and labor-intensive, it provides structured guidelines for clinical researchcoordinators implementing clinical trials.A model standard operating procedure manual for clinical research coordinators is presented thataddresses many issues and roles common to coordinators. Industry criteria and applicable federalregulations that impact the informed consent process, institutional review boards, and drug anddevice studies were utilized to develop the manual. This draft provides a framework that can beformatted to meet the specific requirements of individual institutions.Key Words: Clinical research coordinators; Standard operating procedures; Manual; Clinicaltrials; ProcessesINTRODUCTIONADOPTING WRITTEN STANDARD operating procedures (SOPs) is rapidly becoming astandard requirement when contract research organizations and sponsors select sites for clinicaltrials. Often, well-established processes are in place; however, they may not have been reduced towriting.Clinical research coordinators may find that allocating time for development of a proceduremanual is difficult as they frequently are hard-pressed to fulfill other responsibilities. Thatclinical research coordinators function in multiple roles only increases the challenge. Yet, havingan SOP manual provides benefit to coordinators, especially when they are training new personnel.A model SOP manual for clinical research coordinators was developed. This manual provides aworking framework for institutions drafting their own SOPs.MATERIAL AND METHODSSponsor criteria and applicable federal regulations were utilized to develop the manual. Thesefederal regulations included those impacting the informed consent process (21 CFR, Part 50 [1]and 45 CFR Part 46 [2]); institutional review boards (21 CFR, Part 56 [3] and 45 CFR Part 46);Investigational New Drugs (21 CFR, Part 312 [4]); and significant/ nonsignificant risk devices(21 CFR, Part 812[5]).MODEL STANDARD OPERATING PROCEDURES MANUALThis manual was designed to assist clinical research coordinators (CRCs) in the performance of 
 
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their duties. It is not a substitute for professional education, training, and experience. The clinicalresearch coordinators should be available for consultation, as needed.I. Clinical Research Coordinator A. DefinitionA CRC is an individual with expertise in clinical research trial management. Typically, the CRCis a registered nurse, medical technologist, pharmacist, or other individual with equivalentscientific/clinical background and research experience.B. Roles and ResponsibilitiesThe CRC assists the principal investigator (PI) (usually a physician) and subinvestigators(usually physicians, physician assistants, nurse practitioners, and/or pharmacists) with all aspectsof study implementation. Although the CRC is responsible for coordinating all activities relatedto clinical trial implementation, the CRC can only perform those procedures for which he/she isqualified by training and/or licensure. Responsibilities include:
Identifying research opportunities and contacting potential sponsors,
 Negotiating budget and contract,
Completing regulatory documents,
Facilitating peer review, administrative review, and approval,
Applying for institutional review board (IRB) review,
Interacting with the sponsor, research team, pharmacy, IRB, finance, and other departments impacted by the research,
Developing study processes,
Developing study documents,
Educating staff,
Recruiting, screening, and enrolling subjects,
Implementing and adhering to the protocol,
Accounting for study funds,
Reporting adverse events, and
Providing continuing and final IRB reports.II. Initial Sponsor Contact:
 
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A. Nondisclosure (Confidentiality) AgreementInvestigators are provided with clinical trial opportunities through several sources including pharmaceutical companies or device manufacturers, clinical research organizations (CROs), andsite maintenance organizations (SMOs), hereafter referred to as the "sponsor." Networking withoff-site investigators or coordinators may also afford research opportunities. Before substantialresearch information is disclosed by the sponsor, a Nondisclosure (Confidentiality) Agreement issigned by the principal investigator (PI). This agreement defines the nature and extent to whichconfidentiality must be maintained by the PI and study team. At a mimimum, a nondisclosureagreement should include:
Definition of confidential information (limited to written disclosures),
Disclosure restrictions (what can be disclosed and to whom), and
Termination of certain obligations (a description of circumstances that nullify theagreement). Examples include information that was: 1) in the public domain whenrevealed to the investigator; 2) entered the public domain after disclosure to theinvestigator without any fault on the part of the investigator; 3) known to the investigator free of any obligation of confidentiality as evidenced by written records; 4) required bylaw to be disclosed; and 5) received from a third party with no confidential obligation.
Termination of the agreement (usually three to five years),
Choice of state laws governing the agreement, and
A statement that the entire agreement is embodied in the nondisclosure document. The Nondisclosure (Confidentiality) Agreement may be forwarded to legal counsel for review.A copy (or second original) of the signed Nondisclosure (Confidentiality) Agreementshould be filed in the CRC study notebook.B. Research ContractAll contracts should receive legal review. Modifications will be forwarded to the CRC andincorporated after investigator review and approval. The contract may not be executed until allnecessary approvals are obtained (ie, peer review, administrative approval, IRB, etc.). Anoriginal copy of the signed research contract must be filed in the CRC study notebook.C. Research BudgetTo evaluate the adequacy of the proposed study budget, the coordinator must first review the protocol and identify study-related procedures versus standard of care. All study-related procedures and tests should be reimbursed by the sponsor at a rate comparable to third-party payer reimbursement. Also, compensation should be provided for physician fees, coordinator time, pharmacy charges, overhead, IRB review, and other study-related expenses. Personnel infinance, the physician's office, and other affiliated entities (for example, special procedure billing) may need to be contacted to determine the adequacy of proposed monetaryreimbursement. Another. consideration is the reimbursement schedule. Although each budget is
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