7 Ways to Help Prevent Common Non-Compliance Issues
The HRPP Quality Assurance and Evaluation Team’s commitment to compliance includes the development of educational initiatives and appropriate oversight and monitoring to assist research faculty. This monitoring enables us to identify common pitfalls in the implementation of research and tailor ongoing QA initiatives accordingly.
Below will briefly outline steps that research teams can take throughout the life cycle of a study to help reduce instances of noncompliance. One of the most common noncompliance findings uncovered during study audits is that the research team altered or did not adhere to the IRB-approved study protocol in some way. Over the next few months our team will roll out more detailed information on each topic below to help reduce the potential for noncompliance related to study protocol findings:
Assess your research plan feasibility: Prior to IRB approval and periodically during the study, determine whether the research plan can be carried out as written. This includes whether participants will be/are able to complete the study as written. An effective research plan is clear, consistent and allows for variation (e.g., visit/procedure windows) wherever possible. If the research plan includes confusing or overly narrow language or discrepancies between documents (e.g., consent form and protocol), work with the IRB responsible for oversight of the study and sponsor/funding agency (if applicable) to clarify the language and ensure that the research plan can be implemented. Note that if the research plan must be altered for feasibility or any other reason, you must obtain IRB approval through a modification prior to implementing those changes.
Create data collection forms and checklists: These documents can increase compliance with the research plan by reminding study team members what the research plan requires at each point in the study. These documents should be thoroughly reviewed to ensure consistency with the research plan prior to being used. For example, a checklist could be used to document the consent process and its related components (e.g., that a subject received a copy of the form and was able to ask questions). A checklist could also be used to document each study visit and the different procedures to be performed at the visit. Please reference this link for additional checklist tools:
Create Standard Operating Procedures (SOPs): SOPs are beneficial and recommended for all study teams conducting research, especially clinical research. Key SOPs should address processes such as:
a) roles, responsibilities, training, and delegation
b) informed consent procedures; and
c) adverse event management
Resource Availability: Ensure that training materials, protocol, consent forms, surveys/questionnaires, checklists, and other documentation are accessible to study team and are updated promptly as needed. Study team members should also know where to go to when questions about study implementation arise.
Training: Train study team members on the IRB-approved research plan prior to their involvement in the research as well as when any changes to the IRB-approved materials are made or when new staff join the team. Staff need to be aware of the tasks that they are assigned to perform and principal investigators (PIs) must ensure that staff are properly qualified and trained to perform the tasks assigned.
Document: Complete data collection forms and checklists in a timely manner. If a deviation occurs, proper documentation will tell the story of what happened and hopefully reduce the time between the deviation and its discovery.
Reporting: When deviations from the IRB-approved research plan occur, the investigator must act quickly to ensure subject safety as well as report to sponsor and/or IRB according to each policy and procedures. Information about deviation submission and reporting can be found here:
For assistance please contact:
Andrea Dragan, Quality Assurance and Evaluation Director
andrea.dragan@rutgers.edu
Barbara LoDico, Quality Improvement Senior Analyst
Barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
Smithk6@research.rutgers.edu
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