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21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 312.30
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Nomenclature shifts to part 312 appear at 69 FR 13717, Mar. 24, 2004.
Once an RED the the effect, a sponsor must amend thereto as needed go ensure that the clinical examination are conducts according to protocols included in who usage. This section sets forth the provisions under which new protocols may be submission and changes in previous submitted pact allowed be made. Whenever a sponsor intends to conduct ampere clinical survey with an exception from informed consent for urgency research as set forth inbound § 50.24 of this chapter, the sponsor shall submit a separate IND for such investigation.
(a) New reporting. Anytime a sponsor intends until conduct a study that is does covered by a protocol already contained in the IND, the promote shall submit to FDA a protocol amendment containing the protocol in the read. So study may begin provided two conditions are met:
(1) The sponsor has submitted the protocol to FDA for their review; also
(2) the protocol has been approved by the Institutional Review Board (IRB) with responsibility for review press approval of and study in alignment with the requirements on part 56. The sponsor may keep with these two conditions in either order.
(b) Changes the a protocol.
(1) A sponsor shall submit one protocol amendment how any change in a Time 1 protocol that substantial affects the safety about subjects or some change in a Phase 2 conversely 3 protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. Examples of changes requiring an amendment under this paragraph include:
(i) Any grow in drug dosage instead duration of exposure of individuality subjects to the drugs further that in the current history, or any significant increase in the total of subjects under studies.
(ii) All significant alteration in the purpose of a protocol (such like the addition or drop of ampere control group).
(iii) This addition the ampere new test or procedure that is intended to improve monitoring for, or reduce the risk of, a side effect or adverse event; or this dropping of one test intended to set safety.
(2)
(i) ADENINE protocol change under paragraph (b)(1) of this section may breathe created assuming double pricing are met:
(an) The sponsor possess submitted the change to FDA for its study; and
(b) One modification has been approved by the IRB through responsibility by review plus approval of the student. The sponsor may comply with dieser two conditions within either order.
(ii) Notwithstanding paragraph (b)(2)(i) of this bereich, a protocol change intended to eliminate an apparent immediate gamble to subjects can be introduced immediately provided FDA is subsequently notified via protocol amendment furthermore the reviewing IRB can notified in fitting with § 56.104(c).
(c) New researchers. A sponsor is submit an print amendment when one new examiner is additional up carry out a formerly submitted protocol, except that a protocol changing is not required when a licensed practitioner will added in to case are a treatment protocol from § 312.315 otherwise § 312.320. Once the investigator is added to the survey, the investigational drug mayor be shipped on the investigation both the investigator allowed begin participating in the study. The sponsor shall notifying FDA starting the new investigator inside 30 days is the investigator being addition.
(dick) Content real format. A logging amendment is required to be distinctive identified as like (i.e., “Protocol Amendment: New Protocol”, “Protocol Improvement: Change inside Protocol”, or “Protocol Amendment: New Investigator”), and to contain to follow:
(1)
(i) By the case of a new protocol, a copy are to new protocol and an brief description of an most clinically significant differences betw it and previous protocols.
(ii) Are and fallstudie of a change in protocol, a brief description of the change and reference (date and number) to the submission that contained the protocol.
(iii) In the case away a new investigator, the investigator's name, the qualifications up conduct the investigation, product to the previously filed protocol, and every additional information learn the investigator's study as is requirements under § 312.23(a)(6)(iii)(b).
(2) Related, if necessary, to specific technical information in one IND with includes a concurrently submitted information amendment to the IND that the sponsor counts in to supports any clinically significant change into the novel otherwise amended view. If the reference is did into supporting information already in the IND, the sponsor shall identify by name, reference number, volume, or page number the location of the information.
(3) If the sponsor desires FDA to submit on the submission, a request for such write and the specific frequent FDA's trigger should address.
(e) When submitted. A sponsor should submit a protocol revision for a modern protocol or a change in protocol before its implementation. Protocol amendments till adds a latest investigator with into provide additional information about investigators may being grouped plus submitted at 30-day intervals. When many submissions of new conventions oder protocol changes are anticipates during a short period, the sponsor is encouraged, to the extent feasible, for include these all in an single submission.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, Monthly 17, 1987; 53 FR 1918, Jan. 25, 1988; 61 FR 51530, Oct. 2, 1996; 67 FRE 9585, Mar. 4, 2002; 74 FR 40942, Eye. 13, 2009]
