Standard Operating Procedures in Clinical Research

Clinical research is a branch of medical science that determines safety and effectiveness of medications, medical devices or diagnostic procedures. Clinical research always follows general standard operating procedures (SOP). A general SOP is detailed, written instructions to achieve uniformity of the performance of a specific function. SOPs help clinical research to be completed with conformity each time.

Responsible Party

• The first step is to identify who will be responsible for each task of the research project. In clinical research, the investigator is in charge of the research. The investigator has the responsibility of verifying all associates, colleagues and employees assisting with conducting the study are informed of their obligations and meet all responsibility commitments.

Descriptive Action

• The SOP must include a written process of the clinical research. A written process includes references and a guideline on how the research should be conducted. It ensures the research meets federal regulations and institutional policies to protect the rights and welfare of any human study participants. This process also improves the quality of collected information, which improves the study.

Training

• Associates, colleagues and employees should be trained on individual research protocol. The written process plays a major role in training, as each individual can visualize the duties pertaining to them.

SOP Template

• A general SOP template for clinical research should include a header with the title of the research, original version date, revision date, effective date and the personnel approving the research. This template also has the purpose, responsibilities, instruction and procedures, references and an appendix.