What are the regulations for training home health individuals who are working remotely to collect study data?

Question:

What are the regulatory requirements for training of home health individuals who are working remotely to collect study data?  If personnel have limited roles in the study (i.e. document management, study recruiter) should their CV be on file in addition to training?
- Manager, Clinical Development, Pharma

Response:

FDA regulations allow flexibility in how a principal investigator fulfills the training requirements for staff involved in the conduct of a clinical trial.

FDA regulations allow flexibility in how a principal investigator fulfills the training requirements for staff involved in the conduct of a clinical trial. FDA guidance, “Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects” affirms that the FDA takes a flexible and risk-based approach to training. Based on this guidance, staff - and by extension – those working remotely (such as home health care workers) should have adequate training in their assigned tasks and an awareness of regulatory requirements and standards for protection of human subjects.

WCG IRBs require human research subject protection training of all staff members involved in the procedures specific to the research including the consent process, interaction or intervention with participants, recording data, and submission of reports of unanticipated problems. Principal Investigators, through the initial submission process, are required to confirm that they will ensure that research staff are qualified to perform procedures and duties assigned to them during the research, including completion of human subject protection training.  Consistent with FDA guidance, training may be tailored to the fundamental role of the staff member. 

Training and documentation of training requirements may vary across IRBs and sponsors; so, it is important to ensure that local practices align with the IRB’s and sponsor’s requirements.

Regarding the question of CV’s for remote staff, the site should maintain documentation of each staff member’s qualifications and training to perform their assigned tasks. Consistent with good clinical practices, if maintaining a CV is described in the site’s standard operating procedures on documentation of training, then the site should collect the CVs, revise their SOP with a description of alternative and acceptable documentation of training and experience, or maintain a record of the exceptions as a deviation from the SOP.

About the Author

Yvonne Higgins | Quality Assurance Advisor, Compliance

Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).

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