Ask the Experts: ClinicalTrials.gov Compliance
The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the WCG CenterWatch publication, GCP Questions, FDA Answers.
Question: For ClinicalTrials.gov registration, is the Central Contact Person entry under the facility location intended to be the principal investigator (PI) or sub-investigator(s)?
Answer: Regulations state that the entry can list “either: (A) For each facility participating in a clinical trial, Facility Contact, including the name or title, telephone number and email address of a person to whom questions concerning the trial and enrollment at that site can be addressed; or (B) Central Contact Person, including the name or title, toll-free telephone number and email address of a person to whom questions concerning enrollment at any location of the trial” can be addressed.
The regulation does not specify who the Facility Contact or the Central Contact Person must be. The preamble states that “… the final rule allows, but does not require, responsible parties to submit the name or title of a person knowledgeable about the clinical trial at each site, along with the phone number and email address of that person, which would help prospective human subjects obtain additional, specific information about a clinical trial at a particular location. Responsible parties will also be permitted to submit a Central Contact Person instead of Facility Contact, which will reduce the burden on responsible parties who must submit clinical trial registration information. As noted in the preamble, the Central Contact Person should be fully informed of, and able to respond to, requests for information concerning the clinical trial for all its sites.”
Question: Is the Responsible Party Contact Information entry intended to include sub-investigators as well if the PI is listed as the responsible party contact?
Answer: The regulations say that “Responsible Party Contact Information means administrative information to identify and allow communication with the responsible party by telephone, email and regular mail or delivery service. Responsible Party Contact Information includes the name, official title, organizational affiliation, physical address, mailing address, phone number and email address of the individual who is the responsible party or of a designated employee of the organization that is the responsible party.”
The regulations also define the Responsible Party as “the sponsor of the clinical trial … or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this part for the submission of clinical trial information.”
“For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who the FDA orders to conduct the pediatric postmarket surveillance of the device product.”
Regarding the responsible party, the FDA believes that there must be one, and only one, responsible party for each trial in which results are submitted. Having a single responsible party for each trial “facilitates procedural requirements during registration and results information submission and prevents situations in which both a sponsor and a principal investigator consider themselves the responsible party and submit information the same clinical trial.”
Question: Is a Form 3674 — Certification of Compliance required for an investigational new drug (IND) not intended for commercial purposes and accompanying a clinical trial? The trial is a drug-drug interaction pharmacokinetic study of an herbal preparation and midazolam. If a Form 3674 is required, will this trial need to be registered with ClinicalTrials.gov?
Answer: The FDA requires the submission of Form 3674 with an IND. Please be aware that the determination of whether a trial is an applicable clinical trial (ACT) must be made by the responsible party associated with that trial and familiar with all aspects of the clinical trial. The FDA cannot make that determination for any party. You may also wish to review the “Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial” available on the ClinicalTrials.gov website for more information regarding whether your trial meets the definition of an ACT.