年薪30萬的CRA面試整體思路和面試問題中英文版匯總
發(fā)布日期:2023-10-10 閱讀量:次
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年底新的一波面試潮即將來臨,那該如何準(zhǔn)備呢?此前,查閱許多文章、法律法規(guī),并結(jié)合面試經(jīng)驗及行業(yè)大佬的指點,總結(jié)了面試可能遇到的問題分享給大家。
首先:“所謂“知己知彼百戰(zhàn)百勝",要先清楚面試官想要什么樣的候選人。一般要具備三個條件:(1)強烈加入的意愿;(2)能夠獨立做事,既可以發(fā)現(xiàn)問題,解決問題,又可以預(yù)防風(fēng)險的發(fā)生;(3)團隊協(xié)作,說白了就是你和面試官聊得來嗎?跟這個團隊氣場是否相符?
其次:了解面試問題的構(gòu)架:一般情況monitor skill 占比60%,monitor skill包括各種監(jiān)查技能。soft skill占比40%,Soft skill包括積極性、抗壓力、性格如何、解決問題的能力及強烈加入的意愿等。
最后:回答問題要具有邏輯性,并在適當(dāng)時機展現(xiàn)自己的閃光點。如何回答問題才有邏輯性呢?當(dāng)面試官詢問某個issue怎么處理時,采用這兩步法的思維方式進行回答,一般都會回答得比較完善,至少可以拿80分左右。第一步先進行root case analysts,一般有魚骨法或者 5 whys。第二步針對原因,采取CAPA措施。當(dāng)面試官讓你分享Case時,采用STAR法則回答(見下圖)。S代表SITUATION(情景),描述事件的背景。T代表TASK(任務(wù)),分條描述當(dāng)時你所接到的工作任務(wù)。A代表ACTION(行動),為了完成任務(wù),你采取哪些行動,此處面試官想看看你解決問題的能力。R代表RESULT(結(jié)果),采取行動后,事件的結(jié)果怎么樣。
以上是如何準(zhǔn)備面試的整體思路,接下來匯總了十幾個面試問題供大家參考。
Introduce Yourself
Hi everyone, I’am very glad to have this opportunity to introduce myself. I’m XXX. I graduated from XXX medical university.
In the last XXX years, I have worked at XXX, As a CRA, Responsible for monitoring multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas, and assisting other CRA with co-monitoring activities on-site. Responsibilities include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site monitoring and close-out activities. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. I not only ensured the quality and progress of these trials, but also made grate achievements in enrollment. Besides, establish good cooperation with site staff and cross-functional teams on also my responsibility. I pursue the career path development in clinical trial, and have constantly strengthening my professional skills.
The purpose of this interview is to go further on the road of CRA and enhance core competitiveness in different projects and training. I hope your company can give me an opportunity to show myself, thanks for your listening.
Good Clinical Practice
GCP的宗旨包括兩個重要方面:其一,保護受試者的安全、健康和權(quán)益;其二,保證臨床試驗結(jié)果的準(zhǔn)確性和可靠性。
A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses and reporting of clinical trials that provides assurance that the data and
reported results are credible and accurate, and that the rights, integrity and
confidentiality of trial subjects are protected. (ICH-E6, 1.24)
Ensures the rights, safety and well-being of trial subjects are protected.
Ensures the data from the trial are complete, accurate, and unbiased.
監(jiān)查員的職責(zé)至少包括以下方面:
1、在試驗前確認臨床試驗機構(gòu)已具有參與臨床試驗的資格,包括人員配備與培訓(xùn),實驗室設(shè)備齊全,工作情況良好,預(yù)期有足夠的受試者。
2、在試驗前、中、后期監(jiān)查機構(gòu)和研究者是否遵從已批準(zhǔn)的臨床試驗方案、相關(guān)法規(guī)和SOP。
3、確認每位受試者在參與實驗前簽署知情同意書,了解受試者的入選情況及試驗的進展情況。對研究者未能做到的隨訪、未進行的試驗、未做的檢查。以及是否對錯誤、遺漏做出糾正等,應(yīng)當(dāng)清楚、如實記錄。對修訂的知情同意書,確認未結(jié)束訪視并受影響的受試者重新簽署。
4、核對病例報告表錄入的準(zhǔn)確性和完整性,并與源文件比對。應(yīng)當(dāng)注意核對試驗方案規(guī)定的數(shù)據(jù)在病例報告表中有準(zhǔn)確記錄,并與源文件一致。
5、確認所有SAE在規(guī)定的時間內(nèi)上報告并記錄在source document。
6、負責(zé)對IMP的運輸、接收、儲存、分發(fā)、處理、回收過程進行監(jiān)查。
7、監(jiān)查臨床試驗過程中相關(guān)設(shè)備的定期維護與校準(zhǔn)。
8、每次監(jiān)查后應(yīng)當(dāng)書面報告遞送申辦者,報告內(nèi)容應(yīng)當(dāng)包含監(jiān)查日期、時間、監(jiān)查員姓名、監(jiān)查地點、研究者姓名、監(jiān)查內(nèi)容、項目完成情況、監(jiān)查的發(fā)現(xiàn)、事實、偏離、結(jié)論以及對錯誤遺漏做出的糾正等。
CRA responsilities
Main line of communication between investigator and sponsor. Verify the Investigator has adequate qualifications and resources to conduct the trial and supervise properly. Verify if IP complies with applicable regulatory requirement(s) and site uses it in accordance with sponsor guidance (e.g. storage conditions, subject instructions, distribution and disposition). Verify if informed consent process occurs prior to subject’s participation in a trial. Ensure the investigator receives current investigator brochure (IB) and all other documents, and supplies needed to conduct trial.Confirm eligible subjects are enrolled.Verify if source documents are completed based on ALCOA-C principles and maintained. Confirm the accuracy and completeness of CRF entries, source documents, and other related records. Confirm all adverse events have been reported appropriately. Ensure maintenance of essential documents. Communicate deviations to the Investigator (& sponsor) and work to prevent future occurrences.(ICH GCP 5.18.4)
如何進行中心選點訪視?
第一步:遠程電話調(diào)研中心合作意愿,包括PI和機構(gòu)意向。若表示有意向,與PI及機構(gòu)約拜訪時間,發(fā)送拜訪確認函。CRA需提前熟悉方案、研究者手冊;需提前在官網(wǎng)及微信公眾號查閱該中心機構(gòu)和倫理流程。
第二步:中心篩選訪視時,主要關(guān)注點有以下五方面:
1、“法規(guī)要求”:PI是否在藥物臨床試驗機構(gòu)備案系統(tǒng)備案。機構(gòu)是否備案?
2、“入組速度”:入組限速因素主要考慮的點:科室競爭試驗情況、目標(biāo)患者數(shù)量、目標(biāo)患者入組速度、PI與牽頭研究者關(guān)系、研究者影響力、研究者對試驗的興趣度、研究團隊情況、PI既往項目經(jīng)驗、PI時間是否充裕、研究者積極性等。
3、“啟動速度”:影響中心啟動速度的因素包括倫理上會頻率、立項流程及要求、倫理審查流程及要求、合同簽署流程及要求。
4、“試驗質(zhì)量”:包括既往項目質(zhì)量情況(例如既往稽查情況)、PI既往項目經(jīng)驗、研究團隊情況。
5、“設(shè)施、設(shè)備”:包括是否有項目所需所有檢查,醫(yī)院對應(yīng)的檢查設(shè)備是否完整。也包括科室的一些項目相關(guān)的條件與設(shè)施情況,例如是否有研究資料保存的文件柜、低溫離心機、-70℃/-20℃冰箱、2-8℃恒溫箱等。
第三步:拜訪后跟進工作包括: 及時撰寫PSV。相關(guān)文件回收:CDA、可行性調(diào)查問卷、CV、FD、Medical license、GCP certificate等。發(fā)送follow up letter 給研究者和CRC。
How do you site selection visit?
SQV/PSSV Preparation: Confirm availability of all key study staff. Send formal written confirmation of visit containing agenda, date/time, location, and site staff with whom you need to meet. Review study protocol (study design, inclusion/exclusion criteria, study procedures).
The site visit confirmed the following points: Qualification of principal investigator and site staff(Education and training/Indication experience/Clinical trial experience);Patient population and recruitment strategies;Recruitment period and recruitment expectations. Resource availability (Other ongoing/competitive studies or activities/Time dedicated to other activities, such as, classes, private clinic/ Number of sub-investigators/Study coordinator or other needed personnel assigned). Adequate space, restricted access Exam and general procedures room. Number of beds for hospitalization. Local Laboratory (certified?) and storage room for supplies and samples collection; Equipment (e.g. x-ray, bone scan, ECG); Frequency of IRB/IEC meeting; SAE management; Assess investigator’s interest in the study.
SQV/PSSV Follow-up:Complete qualification visit report. Process documents collected as required by the sponsor. Follow-up on all questions raised during the visit. Write follow-up letter that includes all topics discussed, items agreed, open items/issues with due dates and owners, and other sponsor requirements.
如何順利開展一次啟動會?
SIV的準(zhǔn)備工作包括:
1、系統(tǒng)方面:CTMS系統(tǒng)(更新中心的狀態(tài),添加人員的聯(lián)系方式和職責(zé)、添加計劃、添加文件、地址郵編等信息)、IWRS系統(tǒng)(給研究者/CRC開通賬號)、EDC(給研究者和CRC開通賬號)系統(tǒng)等開通。
2、文件方面:準(zhǔn)備啟動會相關(guān)文件(比如:會議簽字表、培訓(xùn)記錄表、授權(quán)表、site vist log、藥物及生物樣本相關(guān)表格等)。
3、藥物、物資方面:確認藥物存儲地點;確認中心是否有藥物恒溫箱、溫度計、轉(zhuǎn)運箱和低溫冰箱等,如果沒有,需提前一個月向項目組申請購買,確保啟動會前到達中心。確認Lab kits,ISF文件夾,文件柜、打印機等已到達中心。
4、預(yù)約啟動會時間、地點、參會人員(主要研究者團隊、機構(gòu)、其他科室比如影像科)。
SIV執(zhí)行工作包括:
1、提前了解研究者的喜好,預(yù)定餐飲。至少會前一小時到中心布置會場和調(diào)試設(shè)備。提前預(yù)演PPT。提前與CRC分配任務(wù),以保證啟動會順利開展。
2、會議中講解PPT,重點內(nèi)容有:目的、方案設(shè)計、試驗流程、入排標(biāo)準(zhǔn)、AE、SAE相關(guān)處理及上報。啟動會上及時解答研究者問題并做好會議記錄。會議結(jié)束時及時回收并整理相關(guān)簽字文件。
3、實地考察藥房:確認接收、存儲、管理、退還、處置與銷毀IMP的流程。考察實驗室:依據(jù)方案確認實驗室的檢驗分析、儀器校準(zhǔn)、樣本管理和留存、報告結(jié)果放行等流程。
啟動會后跟進工作包括:及時撰寫SIV,回收啟動會相關(guān)文件并歸檔。向研究者反饋會上所提疑問的解決辦法及預(yù)防措施,與研究者溝通入組可能遇到的問題。發(fā)送follow up letter 給PI和CRC。
How do you SIV?
SIV Preparation:Confirm if study site has received all study related material and has access to all applicable systems (EDC/IWRS). IP and instructions delivered to site. Contact site to schedule a date (as soon as possible). Confirm availability of all key study personnel. Review study protocol (study design, inclusion/exclusion criteria, study procedures), as well as the case report form and study reference manual.
SIV Review & Discussion:PPT should be explained well. Especially the study objectives, inclusion and exclusion criteria,test process and nodes,which should be explained clearly to the investigators. On-site essential document review. Confirm site staff member roles and delegated responsibilities.
SIV Follow-up:Follow-up on all questions raised during the visit. Complete initiation visit report. Per ICH GCP a copy of SIV report must be archived in the investigator site file (ISF). Process documents collected as required by the sponsor. Write follow-up letter that includes all topics discussed, items agreed, open items/issues with due dates and owners, and other sponsor requirements.
你是如何監(jiān)查的?
MV準(zhǔn)備工作包括:整理上次以來未解決的問題,做一個Check list(截止上次監(jiān)查以來的新的SDV有哪些?準(zhǔn)備需要遞交EC的PD、藥檢報告等文件。有哪些新入組的病人?)。準(zhǔn)備從上次以來需要上報倫理的文件。預(yù)定機票、查詢天氣、準(zhǔn)備出差物品等。與研究者和CRC預(yù)約拜訪時間后,發(fā)送Conformation letter。
On site 監(jiān)查工作內(nèi)容包括:
1、首先要對ICF進行監(jiān)查,確認在試驗前所有受試者或者其監(jiān)護人均簽署了知情同意書。(詳情見下文知情同意書監(jiān)查要點)
2、SDV和SDR:針對受試者的病歷、ICF、日記卡、CRF、藥物發(fā)放回收記錄表、血樣記錄表、閱片中心等記錄進行SDV。SD記錄要符合美國FDA的ALCOA-C原則和歐盟的CCEA原則。
3、對藥物、物資、生物樣本進行核查:(1)核查藥物的接收、發(fā)放(發(fā)藥時間、劑量、藥物號等)、使用(參照受試者日記卡)、保存(按藥物保存溫度要求存放)、庫存(數(shù)量正確)、回收等是否符合方案要求及GCP要求。藥物庫存是否充裕。查看藥檢報告。(2)物資是否充裕,使用數(shù)量是否正確。(3)關(guān)于生物樣本:樣本的采集處理、儲存條件、運輸條件、使用是否符合方案要求?
4、PD的管理:發(fā)現(xiàn)偏離方案和GCP的事件,根據(jù)PD list 鑒別是屬于minor 還是Major。不同程度的PD采取的解決方案不一樣。
5、不良事件的管理:確認是否有新發(fā)生的AE/SAE/susar/特別關(guān)注的不良事件等。查看AE是否漏記,根據(jù)CTCAE的要求去查看AE記錄是否完整,AE是否申辦方PV部門?SAE是否按要求在24小時內(nèi)上報?隨訪信息是否上報?
6、進行文件方面的監(jiān)查:(1)Check ISF文件夾至少包括:倫理審查遞交信、批件完整;方案、ICF、IB等版本完整,并均已遞交EC。若有版本更新,需對相關(guān)人員培訓(xùn)并做好記錄。藥檢報告及時備案且有效期覆蓋試驗范圍。確認SAE報告內(nèi)容真實且可追溯并進行了追蹤。(2)Check受試者文件夾至少包括:核查ICF、身份證、既往病史、治療史、歷次檢查報告單、CS/NCS臨床判斷、AE轉(zhuǎn)歸是否有證據(jù)、病歷、醫(yī)囑單、用藥記錄等、退出試驗有退出記錄、死亡記錄等。
7、針對此次監(jiān)查發(fā)現(xiàn)的問題,與研究者的溝通解決。與研究者溝通督促入組。若有方案、IB、ICF版本更新的情況,需要對研究者及CRC進行再次培訓(xùn),并將培訓(xùn)記錄保存在ISF中。
MV后跟進工作包括:及時撰寫MVR;監(jiān)查后3天內(nèi)發(fā)送拜訪跟進函。及時上報PD。及時將此次監(jiān)查回收的文件歸檔至eTMF。
How do you IMV?
IMV Preparation:Review the monitoring plan, CRF/eCRF completion guidelines, study reference manual. Review the protocol, protocol amendments, and changes to study procedures since the last visit.Confirm access to all required patient records. Make your travel arrangements as soon as allowed Review all electronic systems (e.g. TMF, EDC, IRT).
IMV During Visit:ICF and AE/SAE review are priorities. Review of 100% of all ICFs and confirmation that all versions of the ICFs are present and have been signed correctly and contemporaneously by each subject. Review of new subjects are a priority. Source document review (SDR)/source data verification (SDV):There is a source entry for each visit and each phone contact with the subject. Drug accountability, reconciliation to be consistently and contemporaneously verified. Review ISF to confirm:IRB/IEC approvals and re-approvals all remain active and Current. Ongoing reports and protocol deviations have been submitted to IRB/IEC. Maintenance of essential documents. Protocol Deviations Management:Ask management if there are any premade tools to assist in the identification and documentation of issues, root causes, action plans. Confirm adverse events and concomitant medications are accurately captured on the CRFs.
IMV Follow-up:Discuss with PI any identified issues, resolution timelines, task ownership. Follow-up of issues previously identified. Complete monitor visit report.
簡單描述一下關(guān)中心訪視?
關(guān)中心是一個動態(tài)的過程,一般在最后一個病人完成最后一次訪視后,當(dāng)然,還有些特殊情況下(比如:質(zhì)量問題,或者入組困難等種種原因)提前關(guān)中心,我們就會進入到項目結(jié)束階段,這個階段我們需要做的事情包括:數(shù)據(jù)清理,數(shù)據(jù)核查,鎖庫,遺留問題解決,財務(wù)結(jié)算,文件歸檔,藥物/血樣/物資回收,統(tǒng)計分析等。關(guān)中心需完成的任務(wù)至少包括以下幾方面:
1、數(shù)據(jù)方面:確認所有數(shù)據(jù)已錄入,SDV已完成,所有query已經(jīng)的到妥善答復(fù)。確認數(shù)據(jù)澄清表已填寫完成,并簽字。然后進行數(shù)據(jù)鎖庫。
2、財務(wù)方面:核對醫(yī)院打款、發(fā)票回收、受試者檢查費、交通補助等。然后進行財務(wù)結(jié)算,填寫經(jīng)費清算表格,PI審核后發(fā)送機構(gòu)審核。
3、文件方面:清點ICF數(shù)量;確認ISF/TMF目錄規(guī)定的所有文件已經(jīng)收集并保存;確認需要遞交倫理的文件均正確,遞交信日期無誤。確認財務(wù)合同及發(fā)票無誤。
4、不良事件管理方面:確認所有的AE報告完整且正確。確認所有SAE上報。確保這些文件都已存檔。
5、藥物、物資、生物樣本清點/回收: 確認數(shù)量對得上、剩余藥物被妥善回收或銷毀、相關(guān)藥物的文件已歸檔,確認藥物記錄信息完整、資料齊全符合關(guān)中心要求。
6、項目自查、第三方稽查:申辦者/CRO對項目進行自查,填寫《自查數(shù)據(jù)表》及關(guān)中心《自查表》?;楹妥圆椴⒄暮笊贽k者可向機構(gòu)辦遞交《臨床試驗關(guān)中心函》。
7、科室/機構(gòu)質(zhì)控:按中心要求《關(guān)閉中心及研究資料歸檔要求》整理歸檔資料完畢,提前一周預(yù)約機構(gòu)質(zhì)控員進行項目關(guān)中心質(zhì)控,機構(gòu)質(zhì)控員確認問題已全部整改,符合關(guān)中心要求后在《結(jié)題簽認表》中簽字。
8、按照中心要求填寫分中心小結(jié)/總結(jié)報告。(遞交臨床試驗結(jié)題分中心小結(jié)/總結(jié)報告,機構(gòu)復(fù)核簽字蓋章。
9、預(yù)約機構(gòu)檔案管理員進行研究資料歸檔。
10、及時完成COV報告。
How do you COV?
COV Preparation:Performed when all subjects have completed study,All data submitted and declared “clean” by data management. Review latest IMV Report (confirm that there are no queries and/or unresolved issues). Review ICH GCP Section 8 for required essential documents.Contact site to schedule a date (as soon as possible).
COV During Visit:Confirm all signed ICFs are filed. Ensure the following documents are accurate and filed at site(SAE forms (including safety reports) ,CRFs ,Data clarification forms ,Regulatory documents (approvals, IRB/IEC partial reports). Confirm 100% of accountability of study medication and ensure a complete reconciliation. Confirm IP return/destruction procedures are Followed.If not provided by the sponsor/EDC, create a list with all AEs/SAEs persisting at the subjects last study visit. Review financial disclosure form requirements. Review potential audit or inspections.
COV Follow-up:Follow up all questions raised during the visit Complete Close-out Visit Report. Write follow-up letter that includes all topics discussed, items agreed, open items/issues with due dates and owners, and other sponsor requirements.
AE怎么監(jiān)查?
首先從合并用藥、受試者日記卡、受試者主訴、研究者開放式提問、體格檢查、實驗室檢查出現(xiàn)異常值有臨床意義等,來發(fā)現(xiàn)AE和SAE。例如:監(jiān)查發(fā)現(xiàn)合并用藥,一定了解使用合并用藥的原因。
如果發(fā)現(xiàn)AE,查看研究者是否對患者進行安全性評估?是否在研究病歷中記錄AE/SAE(需要記錄:名稱、臨床診斷、發(fā)生時間、嚴(yán)重程度、處理措施、與藥物相關(guān)性、隨訪情況(時間、結(jié)果))。若發(fā)生SAE,研究者需要立即上報本中心倫理和申辦方。監(jiān)查過程中如果發(fā)現(xiàn)研究者未按要求進行記錄和上報,需要對研究者進行再培訓(xùn),并保存培訓(xùn)記錄。記 PD并上報倫理。
Serious Adverse Events(SAE)
Any untoward medical occurrence that at any dose(ICH E6 1.50 and ICH E2A II.B):
• results in death
• is life threatening
•requires inpatient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability / incapacity
• results in congenital anomaly/birth defect
• is a medically important event
SAE上報要求:當(dāng)研究者獲知SAE后,研究者應(yīng)當(dāng)立即向申辦者和本中心倫理委員會書面報告所有嚴(yán)重不良事件,隨后應(yīng)當(dāng)及時提供詳盡、書面的隨訪報告。
2-8°C藥物從GCP藥房轉(zhuǎn)運至科室的過程?
第一步:轉(zhuǎn)運箱中放入溫度計和冰袋預(yù)冷30min,開啟溫度計。
第二步:如果溫度降到小于8℃,CRC或者研究護士去GCP藥房取藥。如果溫度未降到8℃以下,將接著預(yù)冷至8℃以下時,CRC或者研究護士進行取藥。
第三步:到達科室,查看溫度計是否有超溫報警,如果無超溫,聯(lián)系授權(quán)護士是否可以立即配藥。如果可以立即配藥,停止溫度記錄,記錄取出來的時間,打印溫度記錄歸檔。如果授權(quán)護士暫時很忙,這時候不能停止溫度記錄。等待研究護士說可以配藥時,停止溫度記錄,記錄取出來的時間,打印溫度記錄歸檔。
藥物超溫如何處理?
藥物超溫分兩種情況:
第一種:超溫藥品未發(fā)給受試者,隔離藥品,找到藥物超溫的的原因(例如:溫度計、冰箱是否在校準(zhǔn)日期內(nèi)?溫度計所放位置是否適當(dāng)?線路老化?),發(fā)超溫報告給申辦方評估是否可用?如果可用,備案EC,解封藥物。如果不可用,備案EC,銷毀/回收。
第二種:超溫藥物發(fā)放給受試者,隔離藥物,找到藥物超溫的的原因,發(fā)超溫報告給申辦方評估是否可用?如果可用,備案EC,解封藥物。如果不可用,藥物超溫備案EC ,受試者服藥備案倫理,讓受試者來中心進行安全性評估,藥物銷毀/回收。
你是如何監(jiān)查藥物的?
首先查看藥物轉(zhuǎn)運至中心的過程,運輸過程是否超溫,確認實際接收數(shù)量和申請數(shù)量是否一致,包裝是否完整。若確認無超溫,數(shù)量一致,包裝完整,導(dǎo)出溫度報告表歸檔ISF。
其次查看藥物接收發(fā)放表,藥物庫存表及溫度記錄表等,核對藥物接收(數(shù)量)、儲存(溫濕度情況)、分發(fā)(數(shù)量是否一致,批號是否正確)、回收(數(shù)量是否對得上,空盒,未用藥物數(shù)量是否正確)、整個流程的管理。
最后查看相關(guān)文件是否符合要求:COA是否備案EC,溫度計和冰箱是否在校準(zhǔn)日期內(nèi),藥物發(fā)放回收表格是否按要求填寫,藥物管理員是否被授權(quán),是否被培訓(xùn),培訓(xùn)記錄是否已歸檔?切記:過期藥物、包裝破損藥物不能發(fā)放給患者。還需要注意:藥物發(fā)給患者時不過期,患者服用一段時間后還有未服的藥物過期了,但還沒到下一次訪視發(fā)藥時間,這種情況也是不允許的。
知情同意書的監(jiān)查
1、ICF是否存在缺頁、少頁,摻雜錯頁或排版錯誤?ICF的版本號和版本日期是否當(dāng)前被倫理批準(zhǔn)的最新版?新版ICF是否給研究者培訓(xùn),培訓(xùn)記錄是否歸檔?確認未結(jié)束訪視并受影響的受試者是否重新簽署新版ICF?
2、ICF 是否給到患者一份?如果研究病歷如果書寫已給到患者,默認已給到患者。
3、ICF簽署時間的問題:無特殊情況下,知情同意書的簽署是否先于任何研究程序。
4、知情過程是否被詳細記錄在研究病歷中。
5、ICF上信息填寫是否正確和完整?
6、篩選失敗患者的ICF是否被保存?
7、患者簽字:ICF簽字是否是本人簽署?如果是家屬簽署,需注明關(guān)系,并注明非本人簽署的原因,但已充分知情告知,同意參加該研究,請某某代簽。醫(yī)生簽字:是否是醫(yī)生簽字,需檢查該醫(yī)生是否被授權(quán)?授權(quán)時間先于知情時間,無不符合常規(guī)的簽字,通過其他原始文件進行cross check 簽字筆跡。
8、無行為能力的受試者應(yīng)由其法定代理人代表其實施知情同意并簽名簽署日期。應(yīng)在符合受試者理解的范圍內(nèi)告知受試者,若受試者有能力,應(yīng)在書面知情同意書上親自簽字并注明。若受試者或者其監(jiān)護人缺乏閱讀能力,應(yīng)當(dāng)有一位公正的見證人見證整個知情同意過程。見證人還應(yīng)當(dāng)在知情同意書上簽字并注明日期。
How do you monitoring ICF?
Review of 100% of all ICFs and confirmation that all versions of the ICFs are present and have been signed correctly and contemporaneously by each subject, review should include also: Current version approved by IRB/IEC has been used. ICF process is recorded in source document. Confirmation ICF was signed prior to any study procedure. Documentation subject received a copy of the ICF. Are all pages of the consent present? Count the pages to ensure that a page did not get missed, lost or misplaced. Did the Site Staff personally sign and date the informed consent? Review pen color, handwriting, and compare to the handwriting on the delegation log.
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作者:醫(yī)藥小A
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