翔悅生技服務有限公司

http://www.mpat.org.tw/pub/Events.asp?ctyp=EVENT&catid=24744&ctxid=32442

課程名稱：103藥品臨床試驗訓練課程-基礎教育訓練課程(三)

辦理時間：103年10月24日(星期五)09:00-17:00。

辦理地點：高雄市立凱旋醫院3樓凱旋廳(高雄市苓雅區凱旋二路130號)

慶祝翔悅生技周年慶，舉辦免費諮詢活動!

免費臨床研究護理師實務工作或生涯規劃諮詢服務

服務區域: 大台北地區

活動期間: 2014 Jun 01~Sep 30

時間: 請來電預約02-22648982或線上填寫報名表; 每次諮詢時間1.5小時

對象: 1. 剛加入臨床試驗領域一年內，

         且在實務執行上有困惑者或要加強實務工作技能者;

      2. 想了解臨床試驗領域個人發展與職涯發展者

諮詢服務地點:來電預約後可以到試驗機構點現場諮詢或翔悅生技辦公室

線上填寫報名表： 
https://docs.google.com/forms/d/1SfpIjfhbLLTR_yFmYgPWo73SqCsXPiaXiyqjLC0z7rY/viewform?c=0&w=1&usp=mail_form_link

近日因工作所需，常與一些資歷超過三年以上的研究護理師聊天。她們皆不約而同拋出一個問題：

「新人在職場轉換過程中本來就會有適應期，資深人員也知道應該要訓練新人在工作中學習。無奈自己一直都很忙，根本就沒空好好跟他們說明為什麼執行細節要這樣做、那樣做。」

的確，公司應該負起教育訓練的職責。然而目前臨床研究護理師的需求總是供不應求，公司只能不斷的壓縮時間、及要求新人自力救濟。但現實是不少護理人員抱著期望轉職到臨床研究護理師，卻因為沒有被好好教導正確的工作流程與態度，因不適應而離職。

惡性循環的後果，資深的臨床研究護理師與主管，被迫時常要面臨人員適應不良異動，導致工作量不斷的增加。更糟的是，一方面要維持現有工作的進度，一方面又要想盡辦法補救出問題的部分。除了不斷的加班、情緒愈來愈暴躁，團隊合作的概念更蕩然無存。

這看似已經打結無解的毛線團，有解了! 無論妳是正打算轉任臨床試驗護理師(或是剛入門的新人)，或是屬於資深的臨床研究護理師，卻苦於分身乏術而無法好好帶領新人作有系統的學習，讓翔悅和妳們共同為臨床研究產業打拼。

透過參與翔悅有系統的課程訓練，妳將會擁有豐富的臨床研究知識，並成為一位具備執行臨床研究技能與醫療相關倫理、法律概念，能與團隊溝通協調的研究護理人員。

為每個新血注入更多的活力與希望，使妳的團隊能和諧並有效的支援與溝通，提昇工作績效與生活品質，將不再是遙不可及的夢。

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線上填寫報名資訊，我們將會盡快與您聯繫： 
https://docs.google.com/forms/d/1zmD8J1pWKObvYbdG44f9sFrCughz-bRrcSIIhoT2KZQ/viewform

The following educational videos were developed by the Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

OHRP anticipates the release of additional training videos in the future. We welcome any feedback or suggestions on content, format, or any other aspect of the training videos. Please send your comments to OHRP@hhs.gov.

These videos are also listed on the OHRP YouTube Playlist.

Research Use of Human Biological Specimens and Other Private Information
http://www.youtube.com/watch?feature=player_embedded&v=yp5GzAmXlPM

Mrs. Julie Kaneshiro, OHRP Policy Team Leader, is interviewed and discusses the challenges and complexities of the application of the HHS regulations at 45 CFR part 46 to activities involving biological specimens and other private information. Mrs. Kaneshiro discusses how to assess whether an activity constitutes non-exempt human subjects research. She clarifies when the HHS regulations do and do not apply to an activity and when an institution is engaged in human subjects research. This is an advanced topic video and is best suited to viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects. This video is also available in RealPlayer format at http://videocast.nih.gov/ram/ohrp_kaneshiro.ram

Reviewing and Reporting Unanticipated Problems and Adverse Events
Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. He discusses the differences between adverse events and unanticipated problems and appropriate responses for investigators, IRBs, and institutions when encountering an unanticipated problem. He also discusses prompt reporting requirements and the difference between external and internal unanticipated problems, what to do in the case of multi-center research, and what information that should be reported to OHRP. This video is also available in RealPlayer format athttp://videocast.nih.gov/ram/ohrp_carome.ram

General Informed Consent Requirements

In this video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with the IRB Chair to go over some issues for obtaining legally effective informed consent from potential subjects with schizophrenia before submitting her protocol to the IRB. These issues include determining capacity to consent, using a legally authorized representative, and meeting the regulatory requirements for the process of informed consent. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent.

Institutional Review Board (IRB) Membership
In this video, all of the characters are fictional.  A Signatory Official, Dr. Quinn, meets with her staff members to discuss establishing an effective and efficient IRB for their institution.  Ms. Hobbs, the future Human Subjects Protections Administrator, provides guidance regarding IRB membership, IRB guidance, quorum requirements, conflicts of interest, alternate members, the difference between recusals and abstentions, appointment of IRB members, written procedures, training, incentives and other relevant information for establishing and maintaining an IRB.  As a dedicated investigator, Dr. Reznor provides relevant input and support to the discussion.

Complex Issues with Research Involving Vulnerable Populations
This video presentation on the additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners starts out at the end of a panel presentation on the additional protections afforded to vulnerable populations described in the subparts B, C, and D or the HHS regulations at 45 CFR part 46.

When the video starts, you will see a fictional OHRP presenter summarizing the key points of the just completed presentation to the audience. She then invites questions from the audience, where she and her colleague (also a fictional OHRP presenter) respond to some rather complex and interesting questions regarding vulnerable populations.

IRB Records

This video provides information regarding the IRB records requirements described at 45 CFR part 46. All of the characters are fictional. The institution portrayed in the video hired a consultant to evaluate its human subjects protections program. The consultant made a number of observations and findings regarding the institution’s compliance with the requirements of the regulations.

In the first scene, the institutional official, Dr. Westerberg, is meeting with the consultant, Ms. Williams, to discuss a plan of action related to some of the findings made by Ms. Williams.

IRB Records II: In the second scene, Ms. Williams is meeting with Mr. Cash, the new Director of the institution’s IRB office, to review in detail the deficiencies she observed and requirements related to the IRB meeting minutes and other IRB records.

To view the videos in RealPlayer format, you must have the Real® Media player installed on your computer to view the training modules. Click the following link to Download the free Real® Media player: http://www.real.com/realplayer. The RealPlayer format videos are hosted on the NIH website. If you have technical difficulties with viewing the videos, please see: http://videocast.nih.gov/faq/#topic4