What The FDA Says About Investigator Responsibilities In DCTs

By Kyle Faget, Esq., partner, Foley & Lardner LLP

DCTs are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local healthcare providers (HCPs). In September 2024, the FDA released a guidance document addressing the conduct of DCTs for drugs, biological products, and devices.¹ The guidance outlines, among other things, investigator responsibilities when conducting clinical trials with decentralized elements.

Use Of Local HCPs

Under the guidance, investigators are responsible for overseeing the conduct of clinical trials, including DCTs, and the supervision of individuals delegated to perform trial-related activities. When permitted by the protocol, investigators can delegate trial-related activities to appropriate local HCPs. That said, local HCPs should be included in a clinical trial only insofar as the protocol-related activities do not require specific training under the protocol. As such, local HCPs do not generally contribute directly or significantly to the trial data, and, therefore, need not be included on the FDA Form 1572.

Investigators must ensure that trial-related activities delegated to local HCPs are conducted according to the investigational plan and applicable regulations and remain responsible for the adequate supervision of those to whom they have delegated these activities. Investigators should communicate any specific instructions included in the protocol to local HCPs for trial-related activities they are delegated to perform to limit variability and to ensure consistency and completeness of the data. Investigators should also review data provided by local HCPs regularly to ensure data quality. Moreover, investigators should evaluate reports from local HCPs to identify abnormal signs or symptoms detected at in-person visits. Investigators should follow up with participants as appropriate. Oversight may include leveraging videoconferencing to allow investigators to oversee local HCPs to ensure activities are being conducted in compliance with the protocol. Because oversight of local HCPs is required, investigators should enroll only as many trial participants as they can appropriately manage to ensure adequate supervision of DCT-related activities. Investigators are not expected to maintain a log of local HCPs performing trial-related activities. However, as part of preparing and maintaining adequate case histories, investigators should ensure that reports from local HCPs include the name of the local HCP and the date when activities were performed.

Such responsibilities include ensuring that delegated activities and/or tasks are conducted according to the investigational plan and in compliance with applicable regulations and relevant laws. Additionally, investigators remain responsible for obtaining informed consent from clinical trial participants, overseeing the administration of the investigational product (IP), and entering trial-related data into trial records as needed.

Use Of Telemedicine

The guidance notes that investigators should ensure that remote clinical trial visits conducted via telehealth comply with laws governing telehealth in the relevant U.S. states or territories and other countries, as applicable. The use of telemedicine in DCTs implicates various state legal and regulatory considerations, as the performance of research or the performance of certain procedures within a clinical trial may and often do fall within and are deemed to be the “practice of medicine.” For example, Texas defines the practice of medicine as:

[D]iagnosing, treating or offering to treat any mental or physical disease or disorder or any physical deformity or injury or performing such actions with respect to individual patients for compensation and shall include clinical medical research, the practice of clinical investigative medicine, the supervision and training of medical students or residents in a teaching facility or program approved by the Liaison Committee on Medical Education of the American Medical Association, the American Osteopathic Association or the Accreditation Council for Graduate Medical Education, and professional managerial, administrative, or supervisory activities related to the practice of medicine or the delivery of health care services.²

Most clinical trials involve some components that are considered standard of care, which will likely be deemed the practice of medicine. When the conduct of a clinical trial or the conduct of standard of care procedures within a clinical trial is considered the practice of medicine, DCT practitioners should be aware of and comply with the various individual state telemedicine regulations, including licensure and practice standard requirements.

Licensure Considerations

Investigators and practitioners providing clinical care to patients as part of a DCT must be licensed in the state in which the trial participant is located unless an exception applies. In some states, licensure can be obtained in an expedited fashion. For example, many states offer a path to licensure through the Interstate Medical Licensure Compact.³ Additionally, some states offer a telemedicine special purpose license. For example, Florida permits an out-of-state licensed healthcare practitioner to provide healthcare services to a patient located in Florida if the out-of-state healthcare professional registers with the applicable board or the Florida Department of Health.³ However, not every state’s telemedicine special purpose license is applicable to DCTs. Of note, Maine’s telemedicine registration is only available for consulting clinicians.⁴

Some common state exceptions to the licensure requirement that may apply to practitioners participating in the conduct of a DCT include a border state exception and a follow-up care exception. The border state exception allows a physician licensed in one state to practice medicine in another state that shares a land border with the state in which the physician is licensed.⁵ In the majority of the states with this exception, a physician may not open an office or meet patients in person within the state. Further, some of the applicable border state exceptions are limited in scope. For example, Washington’s border state exception is limited to practitioners licensed in Canada providing care in an area with a common border with Canada and which is surrounded on three sides by water.⁶

The follow-up care exception to the licensure requirement is another potentially applicable exception that may be utilized for practitioners participating in DCTs. Generally, this exception allows a physician to provide care to a patient in a state where the physician is not licensed if an already existing practitioner-patient relationship exists. This means that the practitioner first treated the patient in the state where the practitioner is licensed and then provides subsequent care to the patient when that patient is located in a different state where the practitioner is not licensed. Currently, 14 states offer some form of the follow-up care exception to licensure.⁷ Some states with this exception require that the practitioner-patient relationship be established first in person where the practitioner is licensed.⁸ This means a patient located in such a state would need to physically visit a clinical trial site where the practitioner is licensed prior to further clinical trial care being provided via telemedicine to the patient located in a different state.

If a practitioner participating in a DCT does not meet a state’s exception to licensure, then the practitioner must be licensed in the state where the clinical trial participant is located when receiving care.

Practice Standard Considerations

In addition to state licensure requirements, practitioners participating as an investigator in a DCT and engaging in patient care and procedures, as well as practitioners providing services and care to patients as part of a DCT, must adhere to state practice standard requirements such as, but not limited to, minimum required modalities, telemedicine informed consent requirements (which may be in addition to the consent requirements for the clinical trial), special telemedicine disclosure and patient identification requirements, and medical records requirements.

When providing care through telemedicine, many states specifically address what minimum modality is required to establish the practitioner-patient relationship and subsequent follow-up care. These modalities include synchronous audio/video communication, synchronous interactive audio using store-and-forward communication, and asynchronous store-and-forward communication. The modality through which the practitioner can establish a valid practitioner-patient relationship depends on the language of the state law, as well as the specific clinical situation. For example, some states require a minimum of interactive audio store-and-forward communication to establish the practitioner-patient relationship.⁹ Some states even require that the practitioner-patient relationship be established via synchronous audio-video communication,¹⁰ whereas others explicitly allow the practitioner-patient relationship to be established via asynchronous store-and-forward communication.

Additionally, more than half of the states require the practitioner to obtain telemedicine-specific informed consent from the patient, secure patient ID verification, and provide special telemedicine disclosures to the patient.¹¹ These requirements are in addition to the standard regulations governing human subjects research, including, but limited to FDA regulations under 21 CFR and DHHS regulations at 45 CFR Part 46.

Compliance with state telemedicine requirements is imperative as not only will most clinical trial sponsors contractually require such compliance, but noncompliance may also subject the practitioner to licensure violations and liability.

References:

1. 22 Tex. Admin. Code § 177.1(2).
2. Interstate Medical Licensure Compact, U.S. State Participation in the Compact, available here.
3. See Fla. Stat. § 456.47(4).
4. Code Me. R. tit. 02-373 Ch. 11, § 3(2).
5. D.C. Code Ann. § 3-1205.02; Md. Health Occ. Code Ann. § 14-302; Mich. Comp. Laws Ann. § 333.16171(i); N.H. Rev. Stat. Ann. § 329:21(III); N.Y. Educ. Law § 6526(2); Ohio Rev. Code Ann. § 4731.36(A); 63 Pa. Cons. Stat. Ann. § 422.34 (applying to allopathic physicians); Pa. Admin. Code § 17.4(a) (applying to allopathic physicians); 49 Pa. Admin. Code § 25.243(a) (applying to osteopathic physicians); 22 Tex. Admin. Code § 172.12(f); Tex. Occ. Code Ann. § 151.056(b)(4); 2022 Va. Acts 463, § 2, available here; Wash. Rev. Code § 18.71.030.
6. Wash. Rev. Code § 18.71.030(12).
7. Alaska Stat. Ann. § 08.02.130(b); Ariz. Rev. Stat. Ann. § 36-3606(E); Idaho Code Ann. § 54-5713(1)(a), (b), (d); 225 Ill. Comp. Stat. Ann. 60/49.5(a)–(c); Ind. Code Ann. § 25-22.5-1-1.1; Kan. Admin. Regs. 100-26-1; Kan. Admin. Regs. 100-26-2 (defining “out of state practitioner”); N.H. Rev. Stat. § 310-A:1-g(IV), (VII); North Carolina Medical Board, Position Statement on Telemedicine, available here; Ohio Rev. Code Ann. § 4731.36(A)(4); Or. Rev. Stat. Ann. § 677.137(3)(c); Or. Admin. R. 847-025-0020(3); Or. Med. Bd., Telemedicine, available here; 22 Tex. Admin. Code § 172.12; Va. Code Ann. § 54.1-2901(A)(33); Va. Code Ann. § 54.1-2901(A)(35); Washington Medical Commission, Telemedicine Policy Number POL2021-02 (Nov. 2021), available here; Wash. Bd. Osteopathic Medicine & Surgery, Policy Statement: Telemedicine (March 2022), available here; Wyo. Admin. Code 052.0001.1 § 7(e).
8. Alaska Stat. Ann. § 08.02.130(b).
9. Ark. Code Ann. § § 17-80-402(4)(e)-(f); Del. Code Ann. tit. 24 § 6003(a); Del. Code Ann. tit. 24 § 6001(5-6) (defining “telehealth” and “telemedicine”); Kan. Stat. Ann. § 40-2,211(a)(5); Minn. Stat. Ann. § 147.033, Subd. 1–2; D.C. Mun. Regs. tit. 17, § 4618.4; W. Va. Code § 30-3-13a(c)(2) (allopathic medicine); W. Va. Code § 30-14-12d(c)(2) (osteopathic medicine).
10. N.M. Admin. Code 16.10.8.7; 30 Miss. Admin. Code Pt. 2635, R. 5.4.
11. Tenn. Comp. R. & Regs. 0880-02-.16.

About The Author:

Kyle Faget is partner at Foley & Lardner, specializing in health care and life sciences law. She advises clients on telemedicine, digital health, and regulatory compliance, including matters involving the FDCA, FCA, AKS, AdvaMed Code, and PhRMA Code. Kyle is recognized by Chambers USA for her expertise in healthcare and life sciences.  Her experience in clinical research and life sciences includes drafting and negotiating agreements for contract research organizations and site management organizations. She has successfully operationalized decentralized clinical trials and advised clients on strategic models for care delivery and revenue streams.  Kyle also regularly advises on advertising and promotion issues, ensuring compliance with FDA regulations. Her work in corporate compliance includes building and operationalizing programs for pharmaceutical and medical device clients, ensuring they enter the U.S. mar