Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial of a drug (21 CFR 312.60 and 812.100). This responsibility should include:
Providing reasonable medical care for study subjects for medical problems arising during participation in the trial that are, or could be, related to the study intervention
Providing reasonable access to needed medical care, either by the investigator or by another identified, qualified individual (e.g., when the investigator is unavailable, when specialized care is needed)
Adhering to the protocol so that study subjects are not exposed to unreasonable risks
The investigator should inform the subject’s primary physician about the subject’s participation in the trial if the subject has a primary physician and the subject agrees to the primary physician being informed.
1. Reasonable Medical Care Necessitated by Participation in a Clinical Trial
During a subject’s participation in a trial, the investigator (or designated subinvestigator) should ensure that reasonable medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial participation. If the investigator does not possess the expertise necessary to provide the type of medical care needed by a subject, the investigator should make sure that the subject is able to obtain the necessary care from a qualified practitioner. For example, if the study involves placement of a carotid stent by an interventional neuroradiologist and the subject suffers a cerebral stroke, the neuroradiologist should assess the clinical status of the subject and arrange for further care of the subject by a neurologist. Subjects should receive appropriate medical evaluation and treatment until resolution of any emergent condition related to the study intervention that develops during or after the course of their participation in a study, even if the follow-up period extends beyond the end of the study at the investigative site.
The investigator should also inform a subject when medical care is needed for conditions or illnesses unrelated to the study intervention or the disease or condition under study when such condition or illness is readily apparent or identified through the screening procedures and eligibility criteria for the study. For example, if the investigator determines that the subject has had an exacerbation of an existing condition unrelated to the investigational product or the disease or condition under study, the investigator should inform the subject. The subject should also be advised to seek appropriate care from the physician who was treating the illness prior to the study, if there is one, or assist the subject in obtaining needed medical care.
2.Reasonable Access to Medical Care
Investigators should be available to subjects during the conduct of the trial for medical care related to participation in the study. Availability is particularly important when subjects are receiving a drug that has significant toxicity or abuse potential. For example, if a study drug has potentially fatal toxicity, the investigator should be readily available by phone or other electronic communication 24 hours a day and in reasonably close proximity to study subjects (e.g., not in another state or on prolonged travel). Study subjects should be clearly educated on the possible need for such contact and on precisely how to obtain it, generally by providing pertinent phone numbers, e-mail addresses, and other contact information, in writing. Prior to undertaking the conduct of a study, prospective investigators should consider whether they can be available to the extent needed given the nature of the trial.
During any period of unavailability, the investigator should delegate responsibility for medical care of study subjects to a specific qualified physician who will be readily available to subjects during that time (in the manner a physician would delegate responsibility for care in clinical practice). If the investigator is a non-physician, the investigator should make adequate provision for any necessary medical care that the investigator is not qualified to provide.
3. Protocol Violations that Present Unreasonable Risks
There are occasions when a failure to comply with the protocol may be considered a failure to protect the rights, safety, and welfare of subjects because the non-compliance exposes subjects to unreasonable risks. For example, failure to adhere to inclusion/exclusion criteria that are specifically intended to exclude subjects for whom the study drug or device poses unreasonable risks (e.g., enrolling a subject with decreased renal function in a trial in which decreased function is exclusionary because the drug may be nephrotoxic) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Similarly, failure to perform safety assessments intended to detect drug toxicity within protocol-specified time frames (e.g., CBC for an oncology therapy that causes neutropenia) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Investigators should seek to minimize such risks by adhering closely to the study protocol.
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