預(yù)篩的定義，以及具體的操作方式，界限等在國內(nèi)甚少被提及，但其實(shí)有一些globaltrial的方案中，會明確寫出預(yù)篩的流程，也會設(shè)置Pre-ScreeningICF和Pre-ScreeningLog等。今天跟大家分享一篇UMBC大學(xué)發(fā)表的有關(guān)"Pre-Screening"和"Secreening"的文章。

　　What is the difference between screening and pre-screening？
　　篩選和預(yù)篩選有什么區(qū)別？

　　“Pre-screening,” for IRB purposes, is the term used to describe activities before obtaining informed consent (i.e., before enrollment) to determine initial eligibility for and interest in a study. Pre-screening may be performed over the telephone, in-person or on-line and may not include any research procedures.
　　基于倫理目的的“預(yù)篩選”是用于描述在獲得知情同意之前（即篩選入組之前）確定患者有沒有初步的資格和興趣進(jìn)入研究的術(shù)語。預(yù)篩選可以通過電話、面對面或在線進(jìn)行，不得包括任何研究程序.

　　“Screening” is the term used to describe activities performed after obtaining consent to ensure participants are qualified for the study. Screening activities include any interaction or intervention with potential participants to determine further eligibility that would not otherwise have been performed if not for the study, or collecting data directly from subjects through written screening tools or oral responses to questionnaire
　　“篩選”一詞用于描述在獲得知情同意后進(jìn)行的活動，以確?；挤先肱?。篩選活動包括與潛在受試者的任何互動或干預(yù)，以確定是否有參加下一步研究的資格，一般通過書面篩選工具或?qū)柧淼目陬^答復(fù)等方式直接從受試者收集數(shù)據(jù)。

　　Regardless of the strategy used, investigators must protect the privacy of the potential participant and the confidentiality of information collected about him/her.
　　無論使用何種收集信息的策略，研究者都必須保護(hù)潛在受試者隱私以及收集到的有關(guān)他/她的信息的保密。

　　Pre-screening
　　預(yù)篩選

　　What information can be collected during pre-screening？
　　在預(yù)篩選過程中可以收集哪些信息？

　　Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual’s ability to come to the research site multiple times. It is not appropriate to gather information that is not directly related to assessing eligibility and suitability. Administering eligibility tests is considered a research activity and may not be conducted during a pre-screening but rather only after the participant has been deemed eligible, agreed to participate, and has signed a consent form. Regardless of the setting, only information pertaining to the participant’s eligibility should be gathered during pre-screen. It may be acceptable to perform very limited protocol procedures as part of a pre-screen if they directly relate to eligibility determinations and an individual verbally consents to have them performed.
　　適合預(yù)篩選的問題可以是涉及研究的具體入排和其他適用的問題，例如，個人多次到達(dá)研究中心的能力。收集與入排相關(guān)沒有直接關(guān)系的信息是不合適的。提供與入排相關(guān)的檢查被視為研究活動，不得在預(yù)篩選期間進(jìn)行，而只能在潛在受試者被視為符合條件、同意參與并簽署知情同意書后進(jìn)行。無論問題如何設(shè)置，在預(yù)篩選期間只應(yīng)收集與潛在受試者入選資格有關(guān)的信息。如果這是直接與潛在受試者入排相關(guān)的，并且潛在受試者已經(jīng)口頭同意，那么可以接受把實(shí)施有限的方案流程作為預(yù)篩的一部分。

　　How should pre-screening over the telephone be done？
　　如何通過電話進(jìn)行預(yù)篩選？

　　To begin a phone pre-screening conversation, a study team member should identify himself or herself as such. Then, potential participants should be：
　　1、Informed of the nature and sensitivity of the questions,
　　2、Told how long the phone call is expected to take,
　　3、Asked whether there might be a better time for them to answer these questions, and offered the option of completing the pre-screening in person, if possible.
　　開始電話預(yù)篩選對話時，研究團(tuán)隊(duì)成員應(yīng)表明自己的身份。那么，潛在的受試者應(yīng)該是：
　　1、了解問題的性質(zhì)和敏感性，
　　2、被告知電話預(yù)計(jì)需要多長時間，
　　3、詢問他們是否有更好的時間來回答這些問題，以及如果可能，研究團(tuán)隊(duì)成員親自當(dāng)面完成預(yù)篩選

　　Next, the study team member should explain that a set of questions will be asked to determine eligibility. Whenever possible, the potential participant should be asked to indicate if s/he appears to be eligible only after all questions have been asked. Sometimes this is not possible, for example, when pre-screening for specific levels of activity. The investigator should consider this carefully when designing pre-screening procedures.
　　接下來，研究團(tuán)隊(duì)成員應(yīng)向潛在受試者解釋將詢問一組問題來確定潛在受試者的入選資格。只要有可能，應(yīng)要求潛在受試者在所有問題都問完后才表明他/她是否符合資格。但有時這是不可能做到的，例如針對特定活動水平進(jìn)行的預(yù)篩選。研究者在設(shè)計(jì)預(yù)篩選程序時應(yīng)仔細(xì)考慮這一點(diǎn)。

　　In the interest of confidentiality, only the potential participant’s first name or initials should be recorded at the beginning of the pre-screening conversation. After the screening conversation, if s/he appears to be eligible and is interested in pursuing the study, contact/identifying information can be recorded – e.g., last name, address, birth date, and Social Security number.
　　為保密起見，在預(yù)篩選對話開始時只應(yīng)記錄潛在受試者的first name或首字母縮寫。在篩選對話之后，如果他/她大概符合資格并且有興趣進(jìn)行該研究，則可以記錄聯(lián)系信息/身份信息——例如，姓氏、地址、出生日期和社會安全號碼。

　　How should pre-screening in person be done？
　　應(yīng)如何親自進(jìn)行預(yù)篩選？

　　Pre-screening is done in person usually when potential participants are finding out about research during routine, non-research activities. The guidelines for the conduct of pre-screening in person are the same as those for conducting prescreening over the telephone.
　　當(dāng)潛在受試者在常規(guī)的非臨床研究活動中被發(fā)現(xiàn)時，通常研究團(tuán)隊(duì)成員會親自當(dāng)面進(jìn)行預(yù)篩選。當(dāng)面進(jìn)行預(yù)篩選的準(zhǔn)則與通過電話進(jìn)行預(yù)篩選的準(zhǔn)則相同。

　　Can pre-screening online be conducted on-line？
　　預(yù)篩選可以在網(wǎng)上進(jìn)行嗎？

　　Yes. In many cases, potential participants prefer online pre-screening. The guidelines for the conduct are the same as those described above for other methods. However, because online survey tools have different privacy policies and terms of use, the investigator must provide reference documentation in the protocol application regarding privacy and confidentiality protections.
　　是的。在許多情況下，潛在受試者者更喜歡在線online進(jìn)行預(yù)篩選。行為準(zhǔn)則與上述其他方法的準(zhǔn)則相同。但是，由于在線調(diào)查工具具有不同的隱私政策和使用條款，研究人員必須在方案中提供有關(guān)隱私和保密保護(hù)的參考文件。

　　Can information be retained from individuals who are pre-screened but not enrolled？
　　是否可以保留已預(yù)先篩選但未入選的個人的信息？

　　Yes, non-identifying information may be retained about individuals who are pre-screened for a study, but do not actually pursue the study or enroll.
　　是的，可能會保留參加預(yù)篩選但最終并未進(jìn)行篩選或入組的個人的非識別信息。

　　Pre-screening sheets from individuals who did not provide identifying information can be retained with no further action. Pre-screening sheets with identifying information may also be retained in research files. Fields containing identifiable information must be blacked out or cut off as soon as it is clear that the individual will not be enrolled.
　　可以保留未提供身份信息的個人的預(yù)篩選表，無需采取進(jìn)一步行動。帶有識別信息的預(yù)篩選表也可以保留在研究文件中。一旦明確潛在受試者將不會入組，包含可識別信息的字段必須被涂黑或移除。

　　What needs to be included in the application for IRB review？
　　預(yù)篩申請倫理審查需要包括哪些內(nèi)容？

　　Protocol： All pre-screening activities are considered part of the participant selection and recruitment process and must be reviewed and approved by the IRB prior to initiation. Pre-screening procedures should be described in the protocol document. In addition, the specific inclusion/exclusion criteria for the study should be stated. The IRB will compare the screening tools with these inclusion/exclusion criteria, to ensure that the questions asked during pre-screening are not beyond the scope of the criteria. Screening tools： The questionnaires, checklists, or other screening tools that will be used must be submitted for IRB review. If pre-screening is to be done over the telephone, investigators should provide a script for IRB review. The script should follow the points outlined above (How should pre-screening over the telephone be done？ section). Consent form： Pre-screening does not need to be described in the consent form because it is done before the consent discussion and documentation of consent takes place.
　　方案：所有預(yù)篩活動都被視為受試者招募過程的一部分，并且必須在開始前得到 IRB 的審查和批準(zhǔn)。預(yù)篩選程序應(yīng)在方案中描述。此外，應(yīng)說明研究的具體納入/排除標(biāo)準(zhǔn)。IRB 會將篩選工具與這些納入/排除標(biāo)準(zhǔn)進(jìn)行check，以確保預(yù)篩選期間提出的問題不超出入排標(biāo)準(zhǔn)的范圍。篩選工具：預(yù)篩過程中使用的問卷、checklist或其他工具必須提交給 IRB 審查。如果通過電話進(jìn)行預(yù)篩選，研究人員將screen script提供 給IRB 審查。screen script應(yīng)遵循上述要點(diǎn)（如何通過電話進(jìn)行預(yù)篩選部分）。知情同意書：不需要在同意書中描述預(yù)篩選，因?yàn)樗窃谕庥懻摵屯馕募巴瓿傻摹?/p>

　　Screening
　　篩選

　　Screening activities include any interaction or intervention with potential subjects to determine eligibility that is performed following a participant’s consent to continue with the research. The IRB protocol application should describe activities in the recruitment process including：
　　1、The screening instruments to be used and script followed to perform the procedures
　　2、How subjects will respond –  e.g., calling in response to advertisements, referrals from other participants,  etc.
　　3、A description of the data, if any, that will be collected..
　　4、How the data collected during the screening procedures will be stored.
　　5、Whether the investigator intends to retain or destroy data collected from subjects who are deemed ineligible upon completion of the screening process.
　　篩選活動包括與潛在受試者的任何interaction或intervention，以確定受試者同意繼續(xù)確認(rèn)他有是否符合入排。IRB 申請資料中應(yīng)描述招募過程中的行動，包括：
　　1、要使用的篩選工具和執(zhí)行程序所遵循的script
　　2、受試者將如何響應(yīng)——例如，響應(yīng)廣告、其他受試者的推薦，電話等。
　　3、對將要收集的數(shù)據(jù)的描述。
　　4、在篩選過程中收集的數(shù)據(jù)將如何存儲。
　　5、研究者是否打算保留或銷毀從篩選過程完成后被認(rèn)為不合格的受試者收集的數(shù)據(jù)。

　　Screening Script
　　自行理解其意義

　　The script must include an introductory statement that informs participants of the purpose of the questions and that they do not have to answer any questions they do not want to answer and must be in language understandable to the population under study.
　　Script必須包括一個介紹性陳述，告知參與者問題的目的，并且他們不必回答任何他們不想回答的問題，并且必須使用受試者可以理解的語言。

　　When appropriate, the script must include an introductory statement warning the subjects of the sensitive nature of the questions that might make the subject uncomfortable, and preferably include an example (for instance, “We are going to ask you about drug or alcohol use.”) The script must not describe the type of questions that will be asked as “confidential;” i.e., rather than saying “we would like to ask you some confidential questions,” say “we would like to ask you some questions.” It is acceptable to say “personal questions” or “sensitive questions.” The purpose of this policy is to prevent any possible misunderstanding that the answers will be held in complete confidence.
　　在適當(dāng)?shù)那闆r下，Script必須包括一個介紹性的陳述，警告受試者可能使受試者不舒服的問題的敏感性，最好包括一個例子（例如，“我們將詢問您有關(guān)藥物或酒精使用的問題。” ) Script不得描述將作為“機(jī)密”提出的問題類型；即，與其說“我們想問你一些機(jī)密問題”，不如說“我們想問你一些問題”。可以說“個人問題”或“敏感問題”。本政策的目的是防止任何可能的誤解，即答案將完全保密。

　　The body of the screening script should the actual questions that will be asked, not just a general statement such as “inclusion/exclusion criteria addressed.” The script must include a closing statement informing participants of whether or not they have met the preliminary screening requirements. If they do, the closing statement whether the information received from the subject will be destroyed immediately, or whether it will be stored, and if so for how long and where.
　　Screen Script的正文應(yīng)該是將要提出的實(shí)際問題，而不僅僅是諸如“是否滿足納入/排除標(biāo)準(zhǔn)”之類的一般性陳述。Script必須包括結(jié)束語，告知受試者他們是否滿足初步篩選要求。如果他們這樣做，結(jié)束聲明是否會立即銷毀從受試者收到的信息，或者是否將其存儲，如果是，則存儲多長時間和儲存在哪里。

　　Note： the IRB realizes that the script may not be followed verbatim, as subjects may ask additional questions or stray from the topic. This is acceptable, but it is expected that the interviewer will keep as closely as possible to the spirit and letter of the script. If a participant refuses to participate in the proposed research, it is recommended that the script detail what information will be obtained and retained. Informed consent may still be required.
　　注意：IRB 明白實(shí)際過程可能不會逐字遵循script，因?yàn)槭茉囌呖赡軙岢銎渌x主題的問題。這是可以接受的，但希望研究者盡可能的貼近Script的精神和文字。如果受試者拒絕參與該研究，建議Script詳細(xì)說明將獲得和保留哪些信息?？赡苋孕枰橥狻?/p>

　　全文手翻，或有錯誤，還是建議看英文原文理解~
　　來源：UMBC