Best Practices for Conducting Research

Investigators should review over the information listed below prior to initiating a new research study as it will help to ensure regulatory compliance and good clinical practices.

  • Know and observe applicable federal regulations, state law and institutional SOPs and/or policies.
  • Know and observe your department’s policies and procedures for research study-related activities.
  • Know and follow the IRB-approved protocol.
  • Know the study-related roles and responsibilities of the principal investigator and other research team members.
  • Differentiate between the study-related and healthcare provider roles and responsibilities.
  • Review the protocol with the research team members, identify and discuss any concerns or questions regarding conduct of the study.
  • Maintain open communication lines with other research team members and investigators, the principal investigator, sponsor and IRB.
  • Ensure that each research team member has access to the most current documents, including, but not limited to, the informed consent document, protocol, and case report forms.
  • Create and use tools to assist in the compliant conduct of the study (worksheets, data collection forms, logs, checklists, etc.).
  • Develop and maintain an effective system for data collection and storage.
  • Implement quality assurance measures to ensure your study is conducted in accordance with the IRB approved protocol, institutional policy, and required regulations. Examples of quality assurance activities may include, but are not limited to:
    • Confirmation of IRB approval before initiation of study-related activities.
    • Use of the current IRB approved consent form in the consenting process.
    • Verification that the potential study subject meets all of the eligibility criteria and none of the ineligibility criteria.
    • Verification that all study activities have occurred in accordance with the IRB approved protocol.
    • Verification that deviations from the IRB approved protocol are addressed in accordance with the IRB approved protocol, federal regulations and institutional policies.
    • Develop and implement a system for organization of the documents found in study participant file to help maintain the file in order and up to date.
    • Develop and implement a system for organization of the documents found in the investigator’s study regulatory file to help maintain the file in order and up to date.
    • Create and utilize a study participant file which is a central location of documents including, but not limited to:
      • signed informed consent.
      • documentation of eligibility criteria, case history, assessment and evaluation of the study participant.
      • documentation of study activities, as well as interventions and interactions with the study participant.
      • progress notes.
      • consultation reports.
      • diagnostic test results and laboratory results.
      • dispensing, and if applicable, return of or use of investigational product.
      • copies of documents from medical records, clinic charts.