Question: What training documentation is required for conducting clinical research studies?

Question:

For initial protocol training, do both the trainee and the trainer need to sign as being trained or can we only have the PI sign confirming that training was done with date trained and who was trained?

- Certified clinical research coordinator

Answer:

There is no regulatory requirement for the investigator or the study staff to sign a document verifying completion of training. 

While the FDA’s guidance on investigator responsibilities recommends that an investigator maintain separate lists of qualified study personnel for each clinical trial, the requirement for signatures documenting training is not addressed in this guidance. 

However, sponsors and IRBs may have specific or acceptable documentation requirements. Whatever practice you adopt, be sure to have an SOP in place that describes training and documentation practices.  Consider including in the SOP a statement that the site may use a different process if mandated by the study sponsor that are consistent with the requirements of the sponsor and the IRB.

About the Author

Yvonne Higgins

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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