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What is a Part 16 hearing?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

If the investigator requests a Part 16 hearing and there is a genuine and substantial issue of fact that warrants a hearing, the Commissioner will designate a presiding officer to schedule and conduct the hearing.

Once the hearing is granted, either party (i.e., the Center or the clinical investigator) may move for summary decision on any or all of the issues. The presiding officer reviews any motions filed, issues a summary decision on the issues raised, and determines whether there exists any genuine and substantial issue of fact to be decided at a hearing. The summary decision issued will be incorporated into a presiding officer’s report.

In the alternative, if a hearing is scheduled pursuant to 21 CFR 16.24, the Center and the investigator will, if feasible, exchange written notices of any published articles or written information to be presented or relied upon at the hearing.

Part 16 hearings are informal, and the rules of evidence do not apply. This means any participant may comment upon or rebut all data, information, and views presented. The hearing begins with Center staff/counsel giving a full and complete statement of the action that is the subject of the hearing and describing the information and reasons supporting disqualification. Center staff/counsel may present any oral or written information relevant to the hearing. The investigator, who may be represented by legal counsel, then may present any oral or written information relevant to the hearing. The hearing consists primarily of the presentation of oral or written information, and direct and reasonable cross-examination.

After the hearing, the presiding officer prepares a written report of the hearing. All written material presented at the hearing will be attached to the report and becomes part of the administrative record along with the hearing transcript. The presiding officer’s report includes a recommended decision and the reasons for the recommendation. When time permits, the parties are given the opportunity to review and comment on the presiding officer’s report.

The report and any comments of the parties are transmitted to the Commissioner who considers them as part of the administrative record to determine whether the investigator should be disqualified. The Commissioner then issues a written decision giving the basis for the final action taken.

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