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A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.
KEY WORDS: Clinical research; standard operating procedures; data quality; research investigator; research staff; training.
Writing and reading about the need for standard operating procedures (SOPs) is almost as exciting as creating, implementing, and tracking a set of SOPs. Do not worry. There are many consultants and possibly members of a practice's current staff that have the ability to create a set of SOPs for conducting clinical research. However, as a clinical research investigator and/or clinical research staff/practice, one must know and understand the importance of standardized procedures and make establishing them a priority. This article will help investigators and practice management personnel understand the need for SOPs, and it will also identify and guide the reader through the process of developing basic SOPs for a clinical research department.
The U.S. Food and Drug Administration (FDA) does not specifically require that a study investigator have SOPs; however, to comply with 21 CFR 312.53 (g), which states that "[investigators] will ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations . . . ," an investigator needs to have a process to document that all clinical research staff members have been trained on their roles and responsibilities and understand the regulations that apply to clinical research.
Whether a clinical research investigator is participating in government-, industry-, institutional- or practice -sponsored clinical research, the investigator and the research staff should have SOPs in place to ensure compliant, accurate, timely, and nonbiased data. Creating SOPs for the clinical research staff provides written guidance and training for investigator and staff. This guidance is another way to ensure that the researchers are complying with local and federal...