FDA06 CFR part 58 FFDCA试验方案和专题实施ppt课件

1、Subpart GProtocol for and Conduct of a Nonclinical Laboratory Study Subpart G实验方案和专题实施实验方案和专题实施Suzhou Research-LeoLiu西山中科-刘振超 58.120 Protocol实验方案实验方案(a)Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol

2、shall contain, as applicable, the following information:(a)每个专题都该当有经过同意的书面实验方案，方案应明晰的描画实验目的和专题实施的方法。实验方案该当包含，但不局限于以下信息： 58.120 Protocol实验方案实验方案(a)(1)A descriptive title and statement of the purpose of the study. (a)(1)描画性的标题专题称号和明确的实验目的。(a)(2)Identification of the test and control articles by name,

3、chemical abstract number, or code number.(a)(2)经过称号、CAS号或代号标识供试品和对照品。 58.120 Protocol实验方案实验方案(a)(3)The name of the sponsor and the name and address of the testing facility at which the study is being conducted. (a)(3)委托方的称号和地址，实施专题的实验机构的称号和地址。(a)(4)The number, body weight range, sex, source of suppl

4、y, species, strain, substrain, and age of the test system.(a)(4)实验系统的数量、体重、性别、来源、种属、品系、亚系和年龄等属性信息。 58.120 Protocol实验方案实验方案(a)(5)The procedure for identification of the test system.(a)(5)实验系统的标识。(a)(6) A description of the experimental design, including the methods for the control of bias.(a)(6)实验设计的

5、描画，包括控制偏向的方法。 58.120 Protocol实验方案实验方案(a)(7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specificatio

6、ns for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications. (a)(7)描画实验系统的饮食，描画溶媒、乳化剂及其他用于溶解和悬浮供试品和

7、对照品的物质。描画内容该当包括饮食污染物可接受程度，假设这些污染物超出可接受程度会影响到专题实施或实验目的。 58.120 Protocol实验方案实验方案(a)(8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration.(a)(8) 剂量程度mg/kg体重或

8、其他单位、给药方法和频率。 58.120 Protocol实验方案实验方案(a)(9) The type and frequency of tests, analyses, and measurements to be made. (a)(9)参数丈量、分析和测试的频率。(a)(10) The records to be maintained。(a)(10)需求保管的记录。 58.120 Protocol实验方案实验方案(a)(11) The date of approval of the protocol by the sponsor and the dated signature of t

9、he study director.(a)(11) SD和委托方签署实验方案的日期。(a)(12) A statement of the proposed statistical methods to be used.(a)(12)估计运用的数据统计方法。 58.120 Protocol实验方案实验方案(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and main

10、tained with the protocol.(b)对方案的变卦、修订及其缘由都该当记录，并得到SD的签署，这些记录该当与方案保管在一同。43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2019 58.130 Conduct of a nonclinical laboratory study专题实施专题实施(a)The nonclinical laboratory study shall be conducted in accordance with the

11、protocol.(a)专题应按照实验方案实施。(b)The test systems shall be monitored in conformity with the protocol. (b)按实验方案要求对实验系统进展察看监控。(c)Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in

12、 a manner that precludes error in the recording and storage of data.(c)标本该当以实验系统、专题、类型和取材日期来标识。这些信息该当显示在标本的容器上，该当一直伴随着标本，预防数据录入和储存错误。 58.130 Conduct of a study专题实专题实施施(d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that sp

13、ecimen histopathologically. (d)执行病理学研讨时，尸检过程对标本的大体察看的记录该当提供应病理学家。 58.130 Conduct of a study专题实专题实施施(e)All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in in

14、k. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the chan

15、ge. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2019 58.130 Conduct of a study专题实专题实施施(e)专题实施过程中产生的数据除了自动数据采集系统产生的数据外都该当得到直接、及时和明晰的记录。