1、FDA06CFRpart58FFDCA試驗方案和專題實施Subpart GProtocol for and Conduct of a Nonclinical Laboratory Study Subpart G試驗方案和專題實施試驗方案和專題實施Suzhou Research-LeoLiu西山中科-劉振超F(xiàn)DA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(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)每個專題都應(yīng)當(dāng)有經(jīng)過批準(zhǔn)的書面試驗方案，方案應(yīng)清晰的描述試驗?zāi)康暮蛯ｎ}實施的方法。試驗方案應(yīng)當(dāng)包含，但不局限于以下信息：FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(a)(1)A descriptive title and statement of the purpose of the study. (a)(

3、1)描述性的標(biāo)題（專題名稱）和明確的試驗?zāi)康摹?a)(2)Identification of the test and control articles by name, chemical abstract number, or code number.(a)(2)通過名稱、CAS號或代號標(biāo)識供試品和對照品。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(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)委托方的名稱和地址，實施專題的試驗機(jī)構(gòu)的名稱和地址。(a)(4)The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.(a)(4)試驗系統(tǒng)的數(shù)量、體重、性別、來源、種屬、品系、亞系和年齡等屬性信息。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(a)(5)The procedure for identificati

5、on of the test system.(a)(5)試驗系統(tǒng)的標(biāo)識。(a)(6) A description of the experimental design, including the methods for the control of bias.(a)(6)試驗設(shè)計的描述，包括控制偏差的方法。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(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)描述試驗系統(tǒng)的飲食，描述溶媒、乳化劑及其他用于溶解和懸浮供試品和對照品的物質(zhì)。描述內(nèi)容應(yīng)當(dāng)包括飲食污染物可接受水平，如果這些污染物超出可接受水平會影響到專題實施或試驗?zāi)康摹DA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(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) 劑量水平（mg/kg體重或其他單位）、給藥方法和頻率。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(a)(9) The type and frequency of te

9、sts, analyses, and measurements to be made. (a)(9)參數(shù)測量、分析和測試的頻率。(a)(10) The records to be maintained。(a)(10)需要保留的記錄。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(a)(11) The date of approval of the protocol by the sponsor and the dated signature of the study director.(a)(11) SD和委托方簽署試驗方案的日期。(a

10、)(12) A statement of the proposed statistical methods to be used.(a)(12)預(yù)計使用的數(shù)據(jù)統(tǒng)計方法。FDA06CFRpart58FFDCA試驗方案和專題實施 58.120 Protocol試驗方案試驗方案(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)對方案的變更、修訂及其原因都應(yīng)當(dāng)記錄，并得到SD的簽署，這些記錄應(yīng)當(dāng)與方案保留在一起。43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002FDA06CFRpart58FFDCA試驗方案和專題實施 58.130 Conduct of a nonclinical laboratory study專題實施專題實施(a)The nonclinical laboratory study shall be conducted in accordan

12、ce with the protocol.(a)專題應(yīng)按照試驗方案實施。(b)The test systems shall be monitored in conformity with the protocol. (b)按試驗方案要求對試驗系統(tǒng)進(jìn)行觀察（監(jiān)控）。FDA06CFRpart58FFDCA試驗方案和專題實施(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)標(biāo)本應(yīng)當(dāng)以試驗系統(tǒng)、專題、類型和取材日期來標(biāo)識。這些信息應(yīng)當(dāng)顯示在標(biāo)本的容器上，應(yīng)當(dāng)始終伴隨著標(biāo)本，預(yù)防數(shù)據(jù)錄入和貯存錯誤。 58.130 Conduct of a study專題實專題實施施FDA06CFRpart58FFDCA試驗方案和專題實施(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)執(zhí)行病理學(xué)研究時，尸檢過程對標(biāo)本的大體觀察的記錄應(yīng)當(dāng)提供給病理學(xué)家。 58.130 Conduct of a study專題實專題實施施FDA06CFRpart58FFDCA試驗方案和專題實施(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專題實專題實施施FDA06CFRpart58FFDCA試驗方案和專題實施(e)專題實施過程中產(chǎn)生的數(shù)據(jù)（除了自動數(shù)據(jù)采集系統(tǒng)產(chǎn)生的數(shù)