FDA06CFRpart58FFDCA试验方案和专题实施

1、FDA06CFRpart58FFDCA试验方案和专题实施Subpart GProtocol for and Conduct of a Nonclinical Laboratory Study Subpart G试验方案和专题实施试验方案和专题实施Suzhou Research-LeoLiu西山中科-刘振超FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)Each study shall have an approved written protocol that clearly indicates the objectives and

2、 all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:(a)每个专题都应当有经过批准的书面试验方案，方案应清晰的描述试验目的和专题实施的方法。试验方案应当包含，但不局限于以下信息：FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(1)A descriptive title and statement of the purpose of the study. (a)(

3、1)描述性的标题（专题名称）和明确的试验目的。(a)(2)Identification of the test and control articles by name, chemical abstract number, or code number.(a)(2)通过名称、CAS号或代号标识供试品和对照品。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(3)The name of the sponsor and the name and address of the testing facility at which the s

4、tudy is being conducted. (a)(3)委托方的名称和地址，实施专题的试验机构的名称和地址。(a)(4)The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.(a)(4)试验系统的数量、体重、性别、来源、种属、品系、亚系和年龄等属性信息。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(5)The procedure for identificati

5、on of the test system.(a)(5)试验系统的标识。(a)(6) A description of the experimental design, including the methods for the control of bias.(a)(6)试验设计的描述，包括控制偏差的方法。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(7) A description and/or identification of the diet used in the study as well as solvents,

6、 emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be c

7、apable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications. (a)(7)描述试验系统的饮食，描述溶媒、乳化剂及其他用于溶解和悬浮供试品和对照品的物质。描述内容应当包括饮食污染物可接受水平，如果这些污染物超出可接受水平会影响到专题实施或试验目的。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(8) Each dosage level

8、, 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) 剂量水平（mg/kg体重或其他单位）、给药方法和频率。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(9) The type and frequency of te

9、sts, analyses, and measurements to be made. (a)(9)参数测量、分析和测试的频率。(a)(10) The records to be maintained。(a)(10)需要保留的记录。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(a)(11) The date of approval of the protocol by the sponsor and the dated signature of the study director.(a)(11) SD和委托方签署试验方案的日期。(a

10、)(12) A statement of the proposed statistical methods to be used.(a)(12)预计使用的数据统计方法。FDA06CFRpart58FFDCA试验方案和专题实施 58.120 Protocol试验方案试验方案(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the

11、protocol.(b)对方案的变更、修订及其原因都应当记录，并得到SD的签署，这些记录应当与方案保留在一起。43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002FDA06CFRpart58FFDCA试验方案和专题实施 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 accordan

12、ce with the protocol.(a)专题应按照试验方案实施。(b)The test systems shall be monitored in conformity with the protocol. (b)按试验方案要求对试验系统进行观察（监控）。FDA06CFRpart58FFDCA试验方案和专题实施(c)Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen co

13、ntainer or shall accompany the specimen in a manner that precludes error in the recording and storage of data.(c)标本应当以试验系统、专题、类型和取材日期来标识。这些信息应当显示在标本的容器上，应当始终伴随着标本，预防数据录入和贮存错误。 58.130 Conduct of a study专题实专题实施施FDA06CFRpart58FFDCA试验方案和专题实施(d) Records of gross findings for a specimen from postmortem ob

14、servations should be available to a pathologist when examining that specimen histopathologically. (d)执行病理学研究时，尸检过程对标本的大体观察的记录应当提供给病理学家。 58.130 Conduct of a study专题实专题实施施FDA06CFRpart58FFDCA试验方案和专题实施(e)All data generated during the conduct of a nonclinical laboratory study, except those that are gener

15、ated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. 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 indica

16、te the reason for such change, and shall be dated and signed or identified at the time of the change. 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

17、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, 2002 58.130 Conduct of a study专题实专题实施施FDA06CFRpart58FFDCA试验方案和专题实施(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