It is usually not very difficult to engage sites who have been chosen to participate in a clinical study at the beginning of the trial. This is an exciting time for any site that is able to bring that new experimental drug or device to their patients who are able to participate in the study! Many times, during the enrollment phase of the study, sites continue to be excited and active in their roles, and this is usually facilitated by sponsors who are actively encouraging their sites to enroll subjects.
However, this is not always the case, as we have seen in the monitoring field. In addition, once enrollment goals have been met, site personnel may begin to “lag” in their efforts towards continuing with the follow-up schedule, protocol requirements, and record maintenance. This is certainly the exception, and not the rule, but many of us at IMARC have experienced a site investigator or coordinator (or both!) where this applies.
In this scenario, what can a monitor do? It is beneficial to both the sponsor and site if any deficiencies noted are communicated to the sponsor, as well as discussed with the site. The site’s principal investigator may be reminded of his or her responsibilities, as referenced in the FDA Guidance for Industry- Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Subjects, CFR 812.100, Subpart E, and CFR 312.50, Subpart D. These general responsibilities include the following:
- Ensuring that the investigation is conducted according to the signed agreement, the investigational plan, and applicable FDA regulations. This would include any and all follow-up procedures, visits, reports, record maintenance, etc. as noted in the protocol and agreement between the site and sponsor.
- Protecting the rights, safety, and welfare under the investigator’s care. Depending on the type of drug or device being investigated, it may be crucial to the subject’s continued safety to have periodic follow-up procedures and evaluations conducted.
- Controlling devices/drugs under investigation.
- Ensuring that informed consent is obtained from each subject in accordance with 21 CFR Part 50 and that the study is not commenced until FDA and IRB approvals have been obtained. If significant new information is found during the course of the study, the sponsor or IRB may require that subjects in follow-up are re-consented with a revised informed consent document that includes this new information.
- In addition, 21 CFR 812 also lists specific investigator responsibilities, including maintaining continuing IRB review and approval and record maintenance.
Monitors should reference any of the above regulations as necessary in the conversations that occur with the site investigators and personnel. It can be frustrating when it appears that sites are not putting forth effort to have subjects complete follow-up visits, are missing study procedures, or are not submitting data in a timely manner. The monitor must remind investigators of their crucial role in the investigation, and continue to work with these sites to ensure that the patients enrolled continue to have their rights, safety, and well-being protected throughout the entire study.
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