FDA06 CFR part 58 FFDCA試驗方案和專題實施ppt課件

1、Subpart GProtocol for and Conduct of a Nonclinical Laboratory Study Subpart G實驗方案和專題實施實驗方案和專題實施Suzhou Research-LeoLiu西山中科-劉振超 58.120 Protocol實驗方案實驗方案(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)每個專題都該當有經(jīng)過同意的書面實驗方案，方案應(yīng)明晰的描畫實驗?zāi)康暮蛯ｎ}實施的方法。實驗方案該當包含，但不局限于以下信息： 58.120 Protocol實驗方案實驗方案(a)(1)A descriptive title and statement of the purpose of the study. (a)(1)描畫性的標題專題稱號和明確的實驗?zāi)康摹?a)(2)Identification of the test and control articles by name,

3、chemical abstract number, or code number.(a)(2)經(jīng)過稱號、CAS號或代號標識供試品和對照品。 58.120 Protocol實驗方案實驗方案(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)委托方的稱號和地址，實施專題的實驗機構(gòu)的稱號和地址。(a)(4)The number, body weight range, sex, source of suppl

4、y, species, strain, substrain, and age of the test system.(a)(4)實驗系統(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。 58.120 Protocol實驗方案實驗方案(a)(5)The procedure for identification of the test system.(a)(5)實驗系統(tǒng)的標識。(a)(6) A description of the experimental design, including the methods for the control of bias.(a)(6)實驗設(shè)計的

5、描畫，包括控制偏向的方法。 58.120 Protocol實驗方案實驗方案(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)描畫實驗系統(tǒng)的飲食，描畫溶媒、乳化劑及其他用于溶解和懸浮供試品和

7、對照品的物質(zhì)。描畫內(nèi)容該當包括飲食污染物可接受程度，假設(shè)這些污染物超出可接受程度會影響到專題實施或?qū)嶒災(zāi)康摹?58.120 Protocol實驗方案實驗方案(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) 劑量程度mg/kg體重或

8、其他單位、給藥方法和頻率。 58.120 Protocol實驗方案實驗方案(a)(9) The type and frequency of tests, analyses, and measurements to be made. (a)(9)參數(shù)丈量、分析和測試的頻率。(a)(10) The records to be maintained。(a)(10)需求保管的記錄。 58.120 Protocol實驗方案實驗方案(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和委托方簽署實驗方案的日期。(a)(12) A statement of the proposed statistical methods to be used.(a)(12)估計運用的數(shù)據(jù)統(tǒng)計方法。 58.120 Protocol實驗方案實驗方案(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and main

10、tained with the protocol.(b)對方案的變卦、修訂及其緣由都該當記錄，并得到SD的簽署，這些記錄該當與方案保管在一同。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專題實施專題實施(a)The nonclinical laboratory study shall be conducted in accordance with the

11、protocol.(a)專題應(yīng)按照實驗方案實施。(b)The test systems shall be monitored in conformity with the protocol. (b)按實驗方案要求對實驗系統(tǒng)進展察看監(jiān)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)標本該當以實驗系統(tǒng)、專題、類型和取材日期來標識。這些信息該當顯示在標本的容器上，該當一直伴隨著標本，預防數(shù)據(jù)錄入和儲存錯誤。 58.130 Conduct of a study專題實專題實施施(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)執(zhí)行病理學研討時，尸檢過程對標本的大體察看的記錄該當提供應(yīng)病理學家。 58.130 Conduct of a study專題實專題實施施(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專題實專題實施施(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)據(jù)外都該當?shù)玫街苯?、及時和明晰的記錄。