Contents
Part 3: Examples of Other Sponsor-Required Documens
Part 4: Documenting the Use of Investigational Drugs
Part 5: Summary of Key Points
Part 3: Examples of Other Sponsor-Required Documents? ?其他贊助商要求的文件示例
In addition to the essential documents included in the GCP guideline, the sponsor may require other documentation. The following lists examples of other documentation that may apply to clinical trials.
除GCP指南中包含的基本文件外，申辦方可能需要其他文件。以下列出了可能適用于臨床試驗的其他文件的示例。
Certificate of Confidentiality? ?保密證書
A Certificate of Confidentiality provides an additional level of protection for the privacy of participants in alcohol and drug abuse research studies. (For more detailed information on Certificates of Confidentiality, go to the Confidentiality and Privacy module)
保密證書為酒精和藥物濫用研究參與者的隱私提供了額外的保護。（有關保密證書的更多詳細信息，請轉(zhuǎn)到保密和隱私模塊）
Quality Assurance Documents? ?質(zhì)量保證文件
Quality assurance documents may include the following:
質(zhì)量保證文件可能包括以下內(nèi)容：
Ⅰ、Research site Initiation Activation Form, which indicates that a site is ready to start study enrollement.
Ⅱ、Site visit logs, to record visits to the research site by quality assurance monitors and other personnel.
1、研究點啟動激活表，表明研究點已準備好開始研究注冊。
2、現(xiàn)場訪問日志，記錄質(zhì)量保證監(jiān)督員和其他人員對研究現(xiàn)場的訪問。
Training Documents? ?培訓文件
A training plan and verification of compliance with the training plan, including:
培訓計劃和培訓計劃合規(guī)性驗證，包括：
Ⅰ、Al training documentation form for each staff person
Ⅱ、Documentation of required assessments training per the study training plan.
Ⅲ、Documentation of study–specific training.
Ⅳ、Pertinent certifications for clinical staff implementing a study intervention.
1、每位員工的所有培訓文件表。
2、根據(jù)研究培訓計劃，記錄所需的培訓評估。
3、學習文件——具體培訓。
4、實施研究干預的臨床人員的相關認證。
Behavioral Therapy Documents? ?行為治療文件
Many CTN studies involve behavioral interventions. Behavioral studies may require essential documents different from, or in addition to, those required by GCP guidelines. These documents may include therapy manuals and materials, audio and videotapes of treatment sessions, and other documents specific to the behavioral intervention that is being studied.
許多CTN研究涉及行為干預。行為研究可能需要不同于GCP指南要求的基本文件，或者需要GCP指南要求的附加文件。這些文件可能包括治療手冊和材料、治療過程的音頻和錄像帶，以及與正在研究的行為干預相關的其他文件。
Source Documents? ?源文件
Source documents are original documents, data, or records that are created during a clinical study, that relates to the medical treatment and the history of the participant, and from which study data are obtained. Source documents are one type of essential document that is required by GCP guidelines.
源文件是臨床研究期間創(chuàng)建的原始文件、數(shù)據(jù)或記錄，與受試者的醫(yī)療和病史有關，并從中獲得研究數(shù)據(jù)。源文件是GCP指南要求的一種基本文件。
The purpose of source documents (GCP 8.3.13) is to:
Ⅰ、Document the existence of study participants.
Ⅱ、Substantiate the integrity of the study data collected.
源文件（GCP 8.3.13）的目的是：
一、記錄研究參與者的存在。
二、證實所收集研究數(shù)據(jù)的完整性。
Examples of Source Documents? ?源文件示例
The following are examples of source documents:
以下是源文檔的示例：
Ⅰ、Adverse event and concomitant medication logs
Ⅱ、Reports of diagnostic test results
Ⅲ、Signed and dated Informed Consent Forms
Ⅳ、Participant diaries
Ⅴ、Appointment calendars
Ⅵ、Progress notes
Ⅶ、Paper case report forms (CRFs) on which data are entered directly onto the CRF, rather than extracted from another source document.
1、不良事件及伴隨用藥記錄
2、診斷試驗結(jié)果報告
3、簽署并注明日期的知情同意書
4、參與者日記
5、預約日歷
6、進度說明
7、紙質(zhì)病例報告表（CRF），其數(shù)據(jù)直接輸入CRF，而不是從其他源文件中提取。
Progress Notes? ?進度說明
These source materials must be readily available and retrievable for quality assurance monitoring and for auditing, for example, by the study sponsor (NIDA) or for inspection by the U.S. Food and Drug Administration (FDA).
這些源材料必須隨時可用，并可檢索，以進行質(zhì)量保證監(jiān)測和審計，例如，由研究發(fā)起人（NIDA）或由美國食品和藥物管理局（FDA）檢查。
The purpose of progress notes is to document participants’ involvement in the study and the study–related care they receive. Both research and clinical staff may complete progress notes.
進度說明的目的是記錄參與者參與研究的情況以及他們接受的研究相關護理。研究人員和臨床人員都可以完成進度記錄。
Progress notes are source documents; and may not be recorded in the study database or sent to the sponsor. Often, progress notes are used on–site to monitor the progress of the study. Another important purpose of progress notes is to substantiate the data recorded in the case report forms (CRFs).
進度說明是源文件；不得記錄在研究數(shù)據(jù)庫中或發(fā)送給申辦方。通常，在現(xiàn)場使用進度記錄來監(jiān)控研究的進度。進度說明的另一個重要目的是證實病例報告表（CRF）中記錄的數(shù)據(jù)。
Progress notes should be concise but should provide enough information that the participant’s study–related activities, and the order in which events occurred, can be easily understood.
進度說明應簡潔但提供足夠的信息，使參與者的研究相關活動以及事件發(fā)生的順序易于理解。
Progress notes are of two types, both considered to be essential study documents:
進度說明分為兩類，都被認為是基本研究文件：
Ⅰ、Clinical notes record information related to the experimental treatment that the participant received during the clinical phases of the study.
Ⅱ、Research notes record information related to the participant's involvement in the research phases (e.g., follow-up assessment visits) of the clinical study.
1、臨床記錄記錄參與者在研究臨床階段接受的實驗治療相關信息。
2、研究記錄記錄了與參與者參與臨床研究研究階段（如隨訪評估訪問）相關的信息。
Click here for a list of information that should be documented in both clinical and research progress notes.
單擊此處查看應記錄在臨床和研究進展說明中的信息列表。
Click here for a summary of Good Medical Record practices that should always be observed when writing progress notes.
單擊此處可獲取撰寫進度說明時應始終遵守的良好病歷做法的摘要。
Case Report Forms? ?個案報告表格
GCP defines a Case Report Form (CRF) as follows:
“A printed, optical, or electronic document designed to record all of the protocol–required information to be reported to the sponsor on each trial subject” (ICH GCP 1.11)
GCP對病例報告表（CRF）的定義如下：
“設計用于記錄所有試驗方案的印刷、光學或電子文件——就每個試驗對象向申辦方報告的所需信息”（ICH GCP 1.11）
Thus, a CRF may be a printed document that a study team member completes in the clinic or an electronic document that is sent directly from a laboratory to the data management center.
因此，CRF可以是研究團隊成員在診所完成的打印文檔，也可以是直接從實驗室發(fā)送到數(shù)據(jù)管理中心的電子文檔。
The purpose of CRFs is to gather study data in a standardized format so that the data can be entered into a computerized database and analyzed. The CRFs record all of the information needed to complete the data analyses used to assess the outcomes of the study.
CRFs的目的是以標準格式收集研究數(shù)據(jù)，以便將數(shù)據(jù)輸入計算機化數(shù)據(jù)庫并進行分析。CRF記錄完成用于評估研究結(jié)果的數(shù)據(jù)分析所需的所有信息。
A CRF is a source document only when study data are entered directly onto the CRF, rather than extracted from another source document (e.g., progress notes).
只有當研究數(shù)據(jù)直接輸入CRF，而不是從另一個源文件（如進度說明）中提取時，CRF才是源文件。
Click to view Clinical Trial Network（CTN） related content
點擊查看臨床試驗網(wǎng)絡（CTN）相關內(nèi)容
CTN–Specific Essential Documents? ?CTN–特定基本文件
CTN investigators are required to maintain a Certificate of Confidentiality, QA, Training, Behavioral Therapy, Source, Progress Note, and CRF documents for CTN studies. Additionally, contact information should be maintained for the following CTN study personnel:
CTN研究人員需要為CTN研究保留保密證書、QA、培訓、行為治療、來源、進度說明和CRF文件。此外，應保存以下CTN研究人員的聯(lián)系信息：
Ⅰ、Key personnel at the Lead Node.
Ⅱ、Key personnel at the Participating Node.
Ⅲ、Key personnel at the NIDA Center for the Clinical Trials Network (CCTN).
Ⅳ、The NIDA Study Medical Officer and other parties who must be contacted when expedited reporting of an adverse event is necessary.
1、牽頭節(jié)點關鍵人員。
2、參與節(jié)點的關鍵人員。
3、NIDA臨床試驗網(wǎng)絡中心（CCTN）的關鍵人員。
4、NIDA研究醫(yī)生和其他必須在需要快速報告不良事件時聯(lián)系的各方。
Part 4: Documenting the Use of Investigational Drugs? ?記錄試驗藥物的使用情況
21 CFR 312.62 requires investigators to maintain adequate records of the disposition of investigational drugs, including dates, quantities, and use by participants. The investigator must also maintain records of receipt.
21 CFR 312.62要求研究人員保留試驗藥物處置的充分記錄，包括日期、數(shù)量和參與者的使用。研究人員還必須保存接收記錄。
The following equation may help in understanding the process of accountability for drug disposition:
以下等式可能有助于理解藥物處置的責任流程：
Although this equation may look simple, in practice accounting accurately for the disposition of an investigational drug can be quite complicated. The investigator must account for every unit of the investigational product (e.g., tablet, capsule, inhaler).
雖然這個等式看起來很簡單，但在實踐中，準確地計算研究藥物的處置可能相當復雜。研究人員必須說明每一單位的試驗產(chǎn)品（如片劑、膠囊、吸入器）。
Let’s take a closer look at what is involved in accounting for every unit of an investigational product.
讓我們更仔細地看一下每單位試驗藥物的核算涉及到什么。
Documentation of the "Amount of Drug Received"? ?記錄“收到的藥品數(shù)量”
Documentation of the "amount of drug received" must account for:
Ⅰ、The total number of capsules, tablets, etc. in every dosage (e.g., 5 mg, 10 mg).
Ⅱ、Multiple lot numbers.
Ⅲ、The type of packaging in which the medication is delivered (e.g., bulk supply, individual kits).
“收到的藥品數(shù)量”的文件必須說明：
1、每劑膠囊、片劑等的總量（如5mg、10mg）。
2、多個批號。
3、交付藥物的包裝類型（如散裝供應、單獨藥盒）。
Documentation of the "Amount of Drug Used"? ?記錄“藥物使用量”
Documentation of the "amount of drug used" must account for:
Ⅰ、The amount of medication that each study participant is individually exposed to.
Ⅱ、The total amount of medication consumed by all study participants.
Ⅲ、The amount of medication that is returned by participants (i.e. unused).
Ⅳ、The amount of medication that is wasted (e.g., lost, dropped down the kitchen sink).
“藥物使用量”的文件必須說明：
1、每個研究參與者單獨接觸的藥物量。
2、所有研究參與者服用的藥物總量。
3、參與者退回的藥物量（即未使用）。
4、浪費的藥物量（例如，丟失、掉到廚房水槽中）。
Verification of the "Amount of Drug on Hand"? ?核實“現(xiàn)有藥品數(shù)量”
Inventory must be taken at regular intervals to verify the "amount of drug on hand." Any discrepancies must be documented.
必須定期清點庫存，以核實“庫存藥品數(shù)量”任何差異都必須記錄在案。
To ensure proper accountability, a carefully designed plan (or standard operating procedure) must be in place at the beginning of the study to document the disposition of the investigational product at each site. This plan must be adhered to throughout the study and, if necessary, modified to ensure 100% accountability. The investigator’s records of drug disposition must agree with the data submitted to the sponsor.
為確保適當?shù)呢熑?，必須在研究開始時制定一份精心設計的計劃（或標準操作程序），以記錄每個試驗點的試驗藥物處置情況。在整個研究過程中，必須遵守該計劃，如有必要，進行修改，以確保100%的責任。研究人員的藥物處置記錄必須與提交給申辦方的數(shù)據(jù)一致。
Summary of Key Points
Ⅰ、Every aspect of a clinical study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) standards and with all applicable regulations.
1、必須記錄臨床研究的各個方面，以獲得有用的數(shù)據(jù)，并證明符合良好臨床實踐（GCP）標準和所有適用法規(guī)。
Ⅱ、GCP guidelines specify the essential documents that must be maintained for every clinical study. These documents are classified according to whether they are normally created before a study begins, while a study is in progress, or after a study is completed or terminated.
2、GCP指南規(guī)定了每項臨床研究必須保存的基本文件。這些文件根據(jù)是否通常在研究開始前、研究進行中或研究完成或終止后創(chuàng)建進行分類。
Ⅲ、Federal regulations require investigators to retain records for 2 years after approval of the investigational drug by the U.S. Food and Drug Administration (FDA) or for 2 years after the study is discontinued and FDA is notified.
3、聯(lián)邦法規(guī)要求研究人員在美國食品和藥物管理局（FDA）批準試驗藥物后保留記錄2年，或在研究中止并通知FDA后保留記錄2年。
Ⅳ、Sponsors may require specific documentation in addition to the list of essential documents specified by GCP.
4、除GCP規(guī)定的基本文件清單外，發(fā)起人可能還需要特定文件。
Ⅴ、Source documents are original documents created during a clinical study, from which study data are obtained. The purpose of source documents is to document the existence of study participants and substantiate the integrity of the study data collected.
5、源文件是臨床研究期間創(chuàng)建的原始文件，從中獲取研究數(shù)據(jù)。原始文件的目的是記錄研究參與者的存在，并證實所收集研究數(shù)據(jù)的完整性。
Ⅵ、Progress notes document participants’ involvement in the study and the study–related care they receive. Progress notes are used to monitor the progress of the study and substantiate the data recorded in the case report forms (CRFs).
6、進度說明記錄了參與者參與研究的情況以及他們接受的研究相關護理。進度說明用于監(jiān)測研究進展，并證實病例報告表（CRF）中記錄的數(shù)據(jù)。
Ⅶ、The purpose of CRFs is to gather study data in a standardized format so that the data can be entered into a computerized database and analyzed. All of the information needed to complete the data analyses used to assess the outcomes of the study is recorded in the CRFs.
7、CRFs的目的是以標準格式收集研究數(shù)據(jù)，以便將數(shù)據(jù)輸入計算機化數(shù)據(jù)庫并進行分析。完成用于評估研究結(jié)果的數(shù)據(jù)分析所需的所有信息都記錄在CRF中。
