FDA publishes Answers to GCP Questions

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The FDA addresses inquiries from stakeholders related to Good Clinical Practice (GCP) on an ongoing basis and has now published responses to questions received from 2017 to 2021. The downloadable Excel-sheet contains questions and the corresponding answers and is searchable by different fields (e,g., topic, date, category).

Categories with many entries are, for examples, the following ones:

• Training and Qualifications
• Records / Recordkeeping  
• Certified Copies
• Electronic Records
• Electronic Signatures
• Informed Consent
• Sponsor Responsibilities

Is it possible to have a Remote Location?

One of the interesting questions asks whether a "satellite site" would be possible under GCP.

The agency answered the following:

• The term "satellite site" is not defined in FDA's regulations or guidance.
• In general, an investigator should have a detailed plan for the supervision and oversight of a clinical trial. Conducting a study from a remote ("satellite") location, is one factor that may compromise the ability of an investigator to provide adequate supervision of the conduct of a clinical trial.
• There should be a subinvestigator responsible for the conduct of the clinical trial at each trial site. Subinvestigators should report directly to the investigator.
• If the "satellite" location is in reasonably close proximity to the one where the clinical investigator normally does business, it could be feasible for him / her to conduct the study at both sites, or at least to adequately oversee the conduct of a subinvestigator at the "satellite site".
• When the proposed "satellite site" is located far away, or in another city, state, province, this would make it difficult for the clinical investigator to successfully conduct and / or oversee the study at that site. The agency therefore recommends that the proposed "satellite site" choose a different individual to conduct / oversee the study (= completely separate study site rather than a "satellite site").
• The individual overseeing the study at that new site would need to sign a separate agreement with the study sponsor.

More information is available under FDA´s Good Clinical Practice Inquiries. There is also an FDA archive available for inquiries prior to 2017.