OECD

Section II 1.2.1

The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.

Section II 1.2.2

These responsibilities should include, but not be limited to, the following functions. The Study Director should:

FDA

58.33

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:

三者一致

CFDA

第三章第九條　　

（一）以簽署姓名和日期的方式批準(zhǔn)試驗(yàn)方案和試驗(yàn)方案變更，并確保質(zhì)量保證人員、試驗(yàn)人員及時(shí)獲得試驗(yàn)方案和試驗(yàn)方案變更的副本；

OECD

Section II 1.2.2.

(a) approve the study plan and any amendments to the study plan by dated signature;

(b) ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study;

(c) ensure that study plans and amendments and Standard Operating Procedures are available to study personnel;

FDA

58.33

(a) The protocol, including any change, is approved as provided by Sec. 58.120 and is followed.

三者基本一致

僅OECD中特別指出在研究的實(shí)施過程中SD應(yīng)與QA保持有效的溝通，這一點(diǎn)其實(shí)也是非常有必要的。

FDA并未在SD職責(zé)中規(guī)定確保QA獲取試驗(yàn)方案和試驗(yàn)方案變更的副本，但在QA的職責(zé)中規(guī)定QA應(yīng)保存試驗(yàn)方案和試驗(yàn)方案變更的副本。

在試驗(yàn)方案和試驗(yàn)方案變更副本的獲取時(shí)限上，CFDA與OECD均提出及時(shí)的要求，而FDA并提出要求。

CFDA

第三章第九條

（二）及時(shí)提出修訂、補(bǔ)充標(biāo)準(zhǔn)操作規(guī)程相關(guān)的建議；

OECD

-

FDA

-

僅CFDA對SD提出該要求。

CFDA

第三章第九條　

（三）確保試驗(yàn)人員了解試驗(yàn)方案和試驗(yàn)方案變更、掌握相應(yīng)標(biāo)準(zhǔn)操作規(guī)程的內(nèi)容，并遵守其要求，確保及時(shí)記錄研究中發(fā)生的任何偏離試驗(yàn)方案或者標(biāo)準(zhǔn)操作規(guī)程的情況，并評估這些情況對研究數(shù)據(jù)的質(zhì)量和完整性造成的影響，必要時(shí)應(yīng)當(dāng)采取糾正措施；

OECD

Section II 1.2.2.

(e) ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study;

FDA

58.33

(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

三者要求基本一致；

CFDA與OECD的描述具體至對方案和SOP的偏離，而FDA描述的更為廣泛一些，包含可能影響研究質(zhì)量和完整性的意料之外的情況。

對于SOP的偏離，OECD要求簡單，SD知曉，并未描述評估與糾正方面的要求。

CFDA

第三章第九條　　

（四）掌握研究工作的進(jìn)展，確保及時(shí)、準(zhǔn)確、完整地記錄原始數(shù)據(jù)；

OECD

Section II 1.2.2

(f) ensure that all raw data generated are fully documented and recorded;

FDA

58.33

(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

對于原始數(shù)據(jù)的記錄要求是一致的；

CFDA中指出SD的職責(zé)是要確保及時(shí)、準(zhǔn)確、完成的記錄；

FDA則指出SD的職責(zé)不僅要確保記錄也要確保被復(fù)核，同時(shí)要求SD確保觀察到的測試系統(tǒng)出現(xiàn)的預(yù)料之外的情況也被記錄并復(fù)核。

CFDA

第三章第九條　　

（五）及時(shí)處理質(zhì)量保證部門提出的問題，確保研究工作符合本規(guī)范的要求；

OECD

-

FDA

58.33

(e) All applicable good laboratory practice regulations are followed.

僅CFDA對SD提出要求，及時(shí)處理QA部門提出的問題。

CFDA

-

OECD

-

FDA

58.33

(d) Test systems are as specified in the protocol.

僅FDA對SD提出該要求。但CFDA與OECD在描述方案中應(yīng)包含內(nèi)容時(shí)，均包含實(shí)驗(yàn)系統(tǒng)。

CFDA

第三章第九條　　

（六）確保研究中所使用的儀器設(shè)備、計(jì)算機(jī)化系統(tǒng)得到確認(rèn)或者驗(yàn)證，且處于適用狀態(tài)；

OECD

Section II 1.2.2

(g) ensure that computerised systems used in the study have been validated;

FDA

-

OECD中僅提到了計(jì)算機(jī)化系統(tǒng)，而CFDA的要求還包含研究中使用的儀器設(shè)備，更為全面。

CFDA

第三章第九條　　

（七）確保研究中給予實(shí)驗(yàn)系統(tǒng)的受試物、對照品制劑得到充分的檢測，以保證其穩(wěn)定性、濃度或者均一性符合研究要求；

OECD

-

FDA

-

僅CFDA對SD提出該要求。

CFDA

第三章第九條　　

（八）確保總結(jié)報(bào)告真實(shí)、完整地反映了原始數(shù)據(jù)，并在總結(jié)報(bào)告中簽署姓名和日期予以批準(zhǔn)；

OECD

Section II 1.2.2

(h) sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice;

FDA

-

與報(bào)告相關(guān)的工作，SD的職責(zé)要求是一致的，

但CFDA描述的角度為SD的職責(zé)下應(yīng)該做什么工作；OECD描述的角度則為SD在報(bào)告中簽字所代表的意義。

CFDA

第三章第九條　　

（九）確保試驗(yàn)方案、總結(jié)報(bào)告、原始數(shù)據(jù)、標(biāo)本、受試物或者對照品的留樣樣品等所有與研究相關(guān)的材料完整地歸檔保存；

OECD

Section II 1.2.2

(i) ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.

FDA

58.33

(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

同：

什么需要被歸檔，要求一致

異：

CFDA在第四十一條中規(guī)定項(xiàng)目結(jié)束后不超過兩周歸檔

FDA要求在研究結(jié)束階段或結(jié)束時(shí)進(jìn)行歸檔

OECD要求研究結(jié)束后歸檔，并且特別指出該條對終止的研究同樣適用

CFDA

第三章第九條　　

（十）在多場所研究中，確保試驗(yàn)方案和總結(jié)報(bào)告中明確說明研究所涉及的主要研究者、主研究場所、分研究場所分別承擔(dān)的任務(wù)；

OECD

Section II 1.2.2

(d) ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study;

FDA

-

CFDA與OECD要求一致。

CFDA

第三章第九條　　

（十一）多場所研究中，確保主要研究者所承擔(dān)部分的試驗(yàn)工作符合本規(guī)范的要求。

OECD

Section II 1.3

The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.

FDA

-

異：

CFDA要求SD確保PI所承擔(dān)的工作符合GLP;

而OECD中則是PI負(fù)責(zé)確保所承擔(dān)的工作符合GLP。