Too many green principal investigators (PIs) blithely sign the U.S. Food and Drug Administration (FDA)-demanded Statement of Investigator (Form 1572) and run the risk of falling into serious trial deviations or even potential legal issues, warns Randall Stoltz, medical director with the Covance Clinical Research Unit in Evansville, Ind.
“You have to ask what you are committing yourself too,” Stoltz says. It is not uncommon at some sites that a site director or coordinator casually hands the 1572 to the investigator, and “They’ll just say there’s something for you to sign” and treat it more like a formality, Stoltz adds.
PIs face serious consequences if they don’t take a hard look at the commitments of the 1572 that they are agreeing to when signing. Stoltz advocates knowing in advance what should be in place to run an effective, compliant trial. For example, do you understand what constitutes a regulatory file? What constitutes a serious adverse event and how to deal with it? What the sponsor/monitor expectations will be before, during, and after the trial’s initiation, conduct, and follow-up periods?
The form spells out what the FDA expects, including PI requirements such as that he/she will:
- Conduct the study in accordance with the relevant, current protocol, and will only make changes [after?] notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
- Personally conduct or supervise any investigations.
- Maintain accurate and adequate records in accordance with 21 CFR Part 312.62 and 312.68 in the Code of Federal Regulations.
- Ensure that all associates, colleagues, and employees assisting in the conduct of any study are informed about their obligations in meeting their relevant requirements.
This is just a partial list of the daunting tasks expected of a PI in a trial, and not something to be taken lightly, stresses Stoltz, who has served as the PI in more than 500 trials. He adds that he’s seen physicians looking into adding clinical trials into their practice as “an easy thing to do and a way to make easy extra money.” That’s a grave mistake, if they are not going to take their obligations regarding ethical, responsible clinical research seriously.