On July 13, 2020 Penn moved to Phase II of research resumption as outlined in the University of Pennsylvania Research Resumption Strategy Master Plan, Research Resumption Phase II, available online here: 百度云搜索，百度云盘资源下载，百度网盘搜索 - 搜百度盘:搜百度盘（SoBaiduPan.com） 是基于百度云搜索，最大的百度云盘资源搜索中心，千万级大数据量，让您一网打尽所有的百度网盘资源. 网盘搜索 站长推荐：2021年新一代百度网盘等云盘免费资源搜索引擎系 ….  In order to streamline the research resumption process, the IRB has re-examined its review process and is providing updated information regarding its expectations and requirements. 

Remote Conduct of Research

All biomedical and social-behavioral human subjects’ activity that can be performed remotely, should be carried out remotely. Permission to conduct remote research activities 灯蓝app下载 not require notification or re-approval by the IRB. All research activities conducted remotely may continue as planned as risks to subjects are considered to be appropriately mitigated.

The IRB expects the following types of research procedures to be conducted remotely with research participants during Phase II:

• Interactions involving survey procedures, interview procedures, oral history, focus groups,  educational tests (cognitive, diagnostic, aptitude, achievement), etc.
• Research involving behavioral interventions
• 蓝灯百度网盘资源下载 百度网盘 百度云 微盘 新浪微盘_如风搜:2021-1-8 · 蓝灯相关的网盘资源搜索，包括百度网盘资源和微盘资源等 最近收录 如风搜 42.96ms 建议反馈 帮助中心 免责声明 用户协议 投诉或建议请来邮: rufengso@yandex.com 手机版 如搜索结果侵犯了您的相关权益请来邮通知，本站将根据相关法律规定 ...

Any in-person contact with research participants during Phase II for the above types of research procedures requires prospective IRB approval prior to commencing in-person contact, even if the study previously qualified as exempt. This applies to research being conducted on or off campus. The following information must be provided:

• Rationale for why the research must be conducted in person at this time and why it cannot be conducted remotely
• Confirmation that the “IRB Required General Precautions for In-Person Engagement with Research Participants” will be followed.
• Approval from the associated Penn school leadership. An email from the appropriate designated leadership personnel within each school is acceptable. The IRB will not review the submission without this email approval being provided to the IRB . Please do not submit until this approval has been obtained. Department Chair approval does not constitute Research Resumption Plan approval. 
• An assessment of how the risk of exposure to COVID-19 and any study related risks are appropriately balanced by or outweighed by the benefit(s) of research participation.
• If the research involves field work performed at an outside facility (e.g., a primary or secondary school, community center, etc.), you must obtain a letter of support from the facility authorizing research to resume at that facility in light of COVID-19. This documentation must be submitted to the IRB.

The IRB also recommends that the following types of research procedures be conducted remotely when possible:

• Prospective collection of some biological specimens for research purposes when collection devices can be shipped to participants (e.g., hair/nail clippings, saliva collection, stool/urine/sweat collection).
• Research involving the collection of data through noninvasive procedures, such as the use of wearable devices when they can be shipped to participants homes (e.g., blood pressure, pulse oximeter, heart monitor, wellness devices, etc.) 

In-Person Research Resumption during Phase II

All Penn researchers are expected to follow their associated 响gui下载相关百度网盘资源下载_百度云下载:2021-9-16 · 响gui下载相关百度网盘资源下载 百度云 下载 按收录时间 按文件大小 按相关性 gui.py百度云下载 gui.py /百度云资源文件类型：back no分类：其它由网友：91***09上传，累计点击973次，下载次数 … including any necessary requirements to submit to school leadership for research resumption 灯蓝app下载 and outlined by their school. All Penn researchers are also expected to follow the 响gui下载相关百度网盘资源下载_百度云下载:2021-9-16 · 响gui下载相关百度网盘资源下载 百度云 下载 按收录时间 按文件大小 按相关性 gui.py百度云下载 gui.py /百度云资源文件类型：back no分类：其它由网友：91***09上传，累计点击973次，下载次数 …, which is based upon current guidance from the Centers for Disease Control, Pennsylvania Department of Public Health, and the Philadelphia Department of Public Health.

The IRB is releasing “Required General Precautions for In-Person Engagement with Research Participants.” The IRB expects all researchers to follow these minimum requirements, irrespective of IRB of Record and the location of research. Teams may utilize additional precautions without IRB approval. Any reduction in these minimum requirements will require prospective approval from the IRB to assess the potential risk to participants. 

As noted in the Required General Precautions, all research teams interacting in person with participants are expected to inform subjects of the potential risks of in-person contact related to COVID-19.

• The IRB is releasing a COVID-19 Informational Sheet for In-Person Participation that research teams across the whole University may use if they do not already have a study specific consent addendum or a revised consent form that contains this information. NOTE: If you already have study specific consent addendum or a revised consent form already approved by the IRB, use of this newly released addendum is not required.
• The COVID-19 Informational Sheet does not need to be submitted to the IRB for approval. It is considered to be approved for use.
• 黑底彩花蓝底白花陶釉装饰碗.zip百度云_百度网盘下载 - 搜索盘:1 天前 · 黑底彩花蓝底白花陶釉装饰碗.zip为搜索盘收集整理于百度云网盘资源，搜索盘不提供保存服务，下载地址跳到百度云盘下载，文件的安全性和完整性请您自行判断。如果感觉本站提供的服务对于您有帮助，请按 Ctrl+D 收藏本网站，感谢您对本站的支持。
• Please review the Remote Consent Guidance for approved methods of sharing this document with participants: http://www.sxhl-t.com/mission-institutional-review-board-irb/guidance/recruitment-and-consent. 

Also noted in the Required General Precautions: Participants must complete a Symptom Questionnaire both 24 hours prior to an in-person visit and at the time of the visit. Please see the “Required General Precautions for In-Person Engagement with Research Participants” for more guidance surrounding this. 

Notes/Reminders:

NOTE: If you are changing or deviating from your protocol temporarily, to eliminate immediate hazards to subject safety due to the pandemic, there is no need to wait for IRB approval. However, the IRB would ask that you submit documentation of the changes in HSERA via an exception request within a reasonable timeframe, so the IRB is aware of the changes. If the changes are permanent, please revise your protocol appropriately via a modification. 盘点那些还能存小视频的云盘/ 网盘测评-致情吖 - 简书:以前百度网盘还叫百度云，拥有同步盘功能，体验并不好。 后来阉割成了现在的百度网盘，在网盘倒闭大潮中抓住机会崛起，在国内几乎是一家独大。 不得不说，百度网盘在存储空间上还是挺大方，新注册直接送的 1T 存储空间，通过做任务，不花钱也可有 2T 永久存储空间，还可以通过微信小程序 ...

NOTE: If COVID-19 associated data from participants may be used for research purposes, the research study consent form should be updated to inform participants of this.  

NOTE: If you utilize a central or commercial IRB, please contact them regarding their submission requirements. If you need additional guidance about IRB related requirements, please contact the IRB office.

REMINDER: If your research involves the collection and/or processing of samples from Covid-19 positive subjects, and the samples will be processed or stored in a Penn research laboratory, please consult with a Biosafety Officer from EHRS prior to commencing research. Please see http://ehrs.upenn.edu/about-ehrs/contact-ehrs for more information. 

Guidance on Protocol Changes Related to COVID-19

The IRB continues to receive questions about what changes require IRB review and approval related to mitigating risk to participants during the pandemic. 

If you are changing the protocol procedures temporarily, to eliminate immediate hazards to subject safety due to the pandemic, there is no need to wait for IRB approval. However, the IRB would ask that you submit documentation of the changes in HSERA within a reasonable timeframe, so the IRB is aware of the changes. The IRB is not providing a specific timeline because patient care should be prioritized during this time and the situation changes daily. 

NOTE: Any changes or deviations that may increase risk of harm to participants or adversely affect the scientific integrity of the data should wait for IRB review. 

• E.g., A total suspension of a therapeutic trial would have to be reported to the IRB if participants are enrolled and may be at risk due to the discontinuance of study procedures, with a plan for managing those risks.  
• E.g., If individuals are not able to travel for an in-person visit because of concerns related to COVID-19, AND it adversely impacts the risk to the participant.

Remote Visits to Substitute for In-Office/Hospital/Clinic visits

《蓝灯》 伊沙 kindle+epub+mobi+azw3+pdf - 百度云网盘 ...:百度云 网盘搜索 云盘助手 《蓝灯》 伊沙 kindle+epub+mobi+azw3+pdf 文件来源： 百度网盘 分享用户： 伊沙 文件大小：-分享时间： Jul 24, 2021 11:40:48 AM 浏览次数 ...

Re-consent Guidance

1. Re-consent is not necessary unless the changes to the research are such that the original consent is no longer valid. 
2. 《三十而已百度云》网盘资源(全1-35集)【1080P蓝光中字 ...:护宝计中计百度云[HD1080p资源][百度云盘链接下载] 《99分女朋友百度云》网盘资源(全1-16集)【1080P蓝光中字】泄露版资源已更新 纪录片《在武汉》百度云(手机版)网盘完结版【1080P中字】无删减资 …
3. Subjects may also be notified of changes to the research via a letter or other form of communication. This does not require submission to the IRB.

Permanent changes should be submitted via an amendment. Temporary changes should be submitted via exception request. Deviations identified after the fact should be submitted per usual IRB policy. The IRB will be flexible with submission timelines given the circumstances. 

 

求蓝灯的百度云资源，感谢！ - Sogou:2021-10-15 · 有的呢 链接:https://pan.baidu.com/s/1mvfftooscvmp6svpgrgsjg 密码:8y75 链接一天内有效，请速度保存！ 满意请采纳，谢谢！ 失效有疑问私 ...

The DHHS Secretary issued a Public Readiness and Emergency Preparedness (PREP) Act declaration for COVID-19 countermeasures on March 10 which restricts the subjects ability to sue related to “countermeasures” described in the declaration. The Secretarial declaration is available at: http://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf. The CICP program is explained at: http://www.hrsa.gov/cicp/about/index.html. Due to this, the following language should be added to the injury section of the informed consent:

Due to the coronavirus public health crisis, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 clinical study. If the order applies, it limits your right to sue the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” go to http://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

 

What is an Emergency Use Authorization?

Congress created the Emergency Use Authorization (EUA) in the Project BioShield Act of 2004 to give the public health system access to a greater range of medical products during a declared emergency. An EUA is intended to allow for faster use of a product compared to an IND/IDE. 

An EUA is not an Emergency Use IND. An EUA is a regulatory authorization from the FDA for the use of unapproved medical products (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]) or the use of approved medical products in unapproved ways to diagnose, treat, or prevent serious diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents.

An EUA has its own distinct statutory and regulatory requirements.  

• FDA Approval: FDA is required to review and approve the request for EUA.
• IRB: Does not require IRB review and approval.
• Informed Consent: May be required at the discretion of the FDA commissioner. Distribution of information (e.g., fact sheets) for healthcare professionals and recipients that contains information on product safety, available alternative products, and the right to refuse administration of the EUA product is required.
• Duration of Approval: Up to one year from the date of the declaration of emergency or for as long as the §564 emergency declaration is in effect, whichever is shorter.

 

油猴(Tampermonkey)插件+脚本+IDM=百度网盘高速下载 - 昌 ...:2021-1-29 · 问题： 百度网盘下载有限速，导致下载速度根本跟不上你的网速。这个在下载一些大型文件的时候尤其突出。 解决： 油猴(Tampermonkey)插件+脚本+IDM 实现多线程高速下载。 我测试的是64位windows7系统，浏览器是Chrome。

Guidance and submission instructions related to the Emergency Use/Compassionate use of investigational drugs/devices is available online here: http://www.sxhl-t.com/how-submit-penn-irb/expanded-access

If consent cannot be obtained due to both incapacity of the patient and unavailability of an LAR, an exception from prospective informed consent requirements may be appropriate.

Exception from Informed Consent Requirements [21 CFR 50.23(a)]

• The subject is confronted by a life-threatening situation necessitating the use of the product,
• Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject,
• Time is not sufficient to obtain consent from the subject's legal representative, AND
• No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.

Note: Exception from informed consent requires an independent assessment from an uninvolved physician prior to or within 5 working days of the use of the article.

有什么网盘可以代替百度网盘？ - 知乎 - Zhihu:2021-4-28 · 百度网盘（百度云 ） 百度云 有什么网盘可以代替百度网盘？显示全部 关注者 7 被浏览 2,162 ... 使用体验是完全秒杀以上所有网盘的。当然，一般人也是用不到那么大、那么多的功能的。云盘 ...

This guidance is applicable to both social-behavioral and biomedical research. The IRB will begin screening initial submissions for the need to comply with posting on clinicaltrials.gov. A flow chart that outlines when posting is required has been added to the IRB website here:  http://www.sxhl-t.com/initial. 

太阳能交通灯项目可行性研究报告.doc - 百度云网盘资源合集 ...:太阳能交通灯项目可行性研究报告.doc 文件名:太阳能交通灯项目可行性研究报告.doc, 文件大小:, 分享者:, 分享时间:null, 浏览次数: 0 次;太阳能路灯项目可行性研究报告.doc 文件名:太阳能路灯项目可行性研究报告.doc, 文件大小:, 分享者:, 分享时间:null, 浏览次数: 0 次;太阳能工艺灯项目可行性研究报告 ...

NOTE: 

• “Interventions” may include, but are not limited to, a drug or device product, a treatment procedure or surgery, social-behavioral intervention, etc.
• 32F834948B1F1FF289F5AD7F41CD49BC85993C17.torrent ...:1 天前 · 32F834948B1F1FF289F5AD7F41CD49BC85993C17.torrent百度云网盘下载，资源大小17.45 KB，搜索盘不提供保存服务 ...
• Please be aware that the International Committee of Medical Journal Editors (ICMJE) and affiliated journals may also require registration on clinicaltrials.gov as a contingency for publication.
• Studies meeting the NIH definition require study teams to complete Good Clinical Practice training. The IRB will not monitor compliance with this requirement. Penn Medicine researchers should continue to reach out to OCR Operations regarding GCP training. Researchers from non-Penn Medicine schools are responsible for compliance with these requirements.

IRB Requirements

1. The following language must be placed into the consent form for studies that require posting: “A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law.  This web site will not include information that can identify you.  At most, the web site will include a summary of the results.  You can search this web site at any time.” 
2. At initial review, teams will be required to provide the NCT registration number, or an explanation of why the study does not require posting, before IRB approval will be given.  Penn Medicine researchers may require consultation with OCR compliance for concurrence of studies not posted on CT.gov. 
3. At the time of closure with the IRB, the study team will be asked to confirm that results have been posted on CT.gov. A copy of the confirmation that results were received must be submitted. Closure with the IRB will not be accepted without this confirmation. 

On-going research: if your research was previously approved and you are unsure whether you are required to post on CT.gov, please contact the following individuals for guidance: 

• Penn Medicine:  ocrctgov@pobox.upenn.edu
• All other schools:  PROVOST-IRB@pobox.upenn.edu 

Rush Processing of COVID-19 Research

The IRB is prioritizing all COVID-19 research that furthers the scientific understanding of COVID19/SARS COV-2 and provides potential for direct benefit to enrolled or future patients. This includes the following: 

1. Treatment studies with potential for direct benefit to those enrolled
2. Specimen collection studies for testing / development of critically needed COVID 19 or antibody tests 
3. Biomedical intervention studies that will help benefit healthcare workers, first responders, and essential personnel in relation to shortage of PPE
4. Treatment studies in which there is unlikely to be direct benefit for enrolled participants
5. Other biomedical intervention studies
6. Chart reviews

Please note the following: 

1. Research teams are responsible for contacting their department chairs to ensure prompt receipt of applications to the IRB office. Please directly contact your department chair upon PI approval in HSERA to facilitate IRB processing. 
2. Whenever possible, please try to coordinate the submission of research requiring convened review to be received by the IRB within 4-5 days of an IRB meeting date. Meeting dates are available online here:  http://www.sxhl-t.com/announcements 
3. Studies that plan to prospectively enroll participants require review by the COVID-19 Committee. Please contact Dr.’s Ian Frank or Daniel Radar for guidance.  
4. Please contact Jessica Yoos or David Heagerty directly to request rush review of COVID-19 studies that fall under the six categories above. 

 

IRB Review and Processing of Research During the Pandemic

• All continuing review submissions will continue to be processed normally. 
• All minimal risk, expedited and exempt research will continue to be processed normally.

Biomedical research requiring convened review will be screened by the IRB staff in light the following: 

1. Is the protocol ‘essential research’ that must continue during this pandemic? Please see the IRB home page for the definition of essential research under  3/17/2020: Important: Message from Emma Meagher, MD - Clinical Research Update #3
2. If a modification submission: the IRB staff will assess whether the change is critical to the safety and well-being of participants. 

If clinician IRB member become unavailable for reviews during this time, the IRB will prioritize all essential research so that clinician IRB members may primarily focus on patient care during this time. Non-essential research that requires convened review may be submitted, but may be held by the IRB office until there is availability to review. 

 

IRB Approval vs. Authorization to Initiate/Continue Research During the Pandemic (Phase 1 Research Resumption)

While the IRB is permitting and processing submissions during the pandemic, approval by the IRB at this time DOES NOT constitute authorization to initiate a protocol, protocol amendment, or continue research procedures (as applicable). 

Penn Medicine

Clinical Trials: During the COVID-19 Pandemic, permitted clinical trial activity is limited to essential clinical trials. Essential clinical trials are those that enroll or follow patients with life threatening or serious conditions for which participation in the clinical trial holds out the clear prospect of the patient directly benefiting. Patients already enrolled into clinical trials who are undergoing safety assessments fall into this definition. Please review the Message from Emma Meagher, MD - Clinical Research Update #3 on the IRB website here for further details: http://www.sxhl-t.com. Please consult with Emma Meagher at emma@upenn.edu for non-oncology trials or Bob Vonderheide at rhv@upenn.edu for oncology trials for guidance if you wish to open a new trial, or if you are unclear whether your protocol constitutes essential research.

Research studies with procedures that may be conducted remotely or virtually (e.g., electronic survey research, record reviews, secondary data analysis) may be conducted at this time, as long as their conduct does not interfere with clinician duties and patient care during the pandemic.  Please consult with OCR for authorization to conduct such research. Please ensure that you have adequate study staff and resources.

Other Schools

Only research studies with procedures that may be conducted remotely or virtually may be conducted at this time (e.g., electronic survey research, record reviews, secondary data analysis).  Please also refer to any guidance provided by your school.

百度网盘百度云_百度网盘小说资源-第3页-小说搜搜 ...:百度网盘百度云，百度网盘百度网盘下载地址，百度网盘会员为您提供海量的资源分享下载，小说搜搜专业百度网盘小说搜索引擎为您带来最完美的小说搜索体验，精准直达！

In the event of a health pandemic (i.e. COVID-19 declared on March 11, 2020) documenting consent from subjects utilizing methods other than pen and paper will be permitted. The IRB has collaborated with the PSOM Office of Clinical Research to develop a guidance on Remote Consent Procedures during the current pandemic. This document contains guidance on documentation and consent discussions. Remote consent guidance is available online here: http://www.sxhl-t.com/mission-institutional-review-board-irb/guidance/recruitment-and-consent.

Updates to Forms

The IRB has updated the following submission forms outlined below. Please utilize the most recent version of these forms when submitting to the IRB:  

1. Quality Improvement Project Application: To be used to help determine if an activity qualifies as quality improvement. Completed forms should be submitted to the QI IRB email inbox (qiirb@upenn.edu). The form has been enhanced to capture use of FDA regulated products. 
2. Human Subjects’ Research Determination Form: To be used to help determine whether IRB submission is required. Completed forms should be sent to an IRB Analyst. The form has been enhanced to specifically delineate the differences between de-identified and coded data. 
3. Devices in Research Form: To be used to help the IRB determine whether a study is exempt from IDE regulations as well as the risk of the device. The form has been enhanced to provide additional guidance. 
4. Continuing Review Form: The continuing review form has been updated to collect additional information on recruitment. 

The forms are available for download online here: http://www.sxhl-t.com/forms. Submissions utilizing older versions of these forms will be returned starting 9/1/2020. 

• The Food & Drug Administration (FDA) has issued guidance relating to Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic for March. Please see the linked guidance document for details on this update. 
• The National Institue of Health (NIH) has issued information for NIH applicants and recipients of NIH funding. Please see the linked website for further details on NIH funding. 

The requirements regarding the execution of clinical research will apply until further notice.

Please consult with Emma Meagher at emma@upenn.edu for non-oncology trials or Bob Vonderheide at rhv@upenn.edu for oncology trials for guidance if you wish to open a new trial.   

• Permitted clinical trial activity is limited to essential clinical trials. Essential clinical trials are those that enroll or follow patients with life threatening or serious conditions for which participation in the clinical trial holds out the clear prospect of the patient directly benefiting. Patients already enrolled into clinical trials who are undergoing safety assessments fall into this definition.
• No new clinical trials may be initiated at this time unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials or Bob Vonderheide for oncology trials for guidance if you wish to open a new trial. 
• No new enrollment of research participants into existing clinical trials may occur unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials, or Bob Vonderheide for oncology trials for guidance if you wish to enroll new participants. 
• In-person research visits should continue for participants already enrolled in essential clinical trials if it is essential for patient safety and/or the participation in the clinical trial is an integral part of the patient’s treatment plan. The study physician, in consultation with the study team, the patient’s physician, the patient, and the patient’s family should carefully assess the necessity and risks of an in-person visit. All other in-person clinical research visits must be postponed.
• Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-ins with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.
• Research staff should work remotely, unless their presence is required for the safe conduct of the trial.
• Principal Investigators should let commercial sponsors know that opening new ‘non-essential’ clinical trials and enrollment into ongoing ‘non-essential’ clinical trials is temporarily postponed.

Note: Although the below guidance applies to Penn Medicine, we recommend that non-Penn Medicine researchers review the guidance for any procedures that may be prudent or necessary to ensure the safety of participants and research staff.

Based on the March 13th, 2020 communication from Penn Medicine we are updating the guidance regarding the execution of clinical research. 

• Non-essential ‘in-person’ clinical research appointments and procedures for research participants should be canceled.
• Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-in with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.
• Research visits that are directly linked to treatment and/or essential for the clinical care of existing research participants should continue to take place. 
• Monitoring and auditing of research studies should be conducted remotely. 
• 黑底彩花蓝底白花陶釉装饰碗.zip百度云_百度网盘下载 - 搜索盘:1 天前 · 黑底彩花蓝底白花陶釉装饰碗.zip为搜索盘收集整理于百度云网盘资源，搜索盘不提供保存服务，下载地址跳到百度云盘下载，文件的安全性和完整性请您自行判断。如果感觉本站提供的服务对于您有帮助，请按 Ctrl+D 收藏本网站，感谢您对本站的支持。
• New participant enrollment onto existing studies should only proceed if the principal investigator believes it is in the best interest of the research participant.
• Principal Investigators should let commercial sponsors know that enrollment into ongoing trials is temporarily postponed. 
• As a reminder, when working remotely with PHI, you should only use approved and compliant options, such as Secure Share, PennBox, or other Penn-managed shared drives. 

If you have questions about this guidance, please send inquiries to:

• IRB related inquiries: 灯蓝百度云盘
• Other research related inquiries: psom-ocr@pobox.upenn.edu

Penn Medicine has instituted mandatory COVID19 travel-screening questions for all patients who are seen at Penn Medicine. Because many patients are also research participants, the Penn IRB and OCR are providing the following clarifications to the Penn Clinical Research Community.

• COVID-19 Mandatory Screening in the Health System: Mandatory PennChart screening procedures/questionnaires are not considered part of the “IRB-approved procedures” for your protocol, and therefore do not trigger the need for an amendment to the protocol. These screening procedures do not constitute a change in IRB-approved research procedures unless you choose to incorporate the data collected under the mandatory screening into your research plan. If you do wish to include data obtained from health system-required screening procedures, an amendment or new protocol should be submitted to the IRB to use that data.

• Changes to IRB-Approved Protocols: According to IRB policy, any changes in IRB-approved research procedures must be reported to the IRB and may not be implemented prior to review and approval by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and by FDA regulations (21 CFR §56.108(a)(4)). Beyond the regulation, Penn Medicine also has a responsibility to ensure the safety of its employees. As such, interim measures to reduce immediate hazards to research participants and staff – which may involve deviating from IRB-approved study procedures prior to securing IRB approval – may be warranted to relieve an immediate hazard and to ensure consistency with Penn Medicine polices during this time.

 

响gui下载相关百度网盘资源下载_百度云下载:2021-9-16 · 响gui下载相关百度网盘资源下载 百度云 下载 按收录时间 按文件大小 按相关性 gui.py百度云下载 gui.py /百度云资源文件类型：back no分类：其它由网友：91***09上传，累计点击973次，下载次数 …

• Conducting  phone visits in lieu of in-person visits
• Research procedures that might be completed without requiring that participants travel to Penn Medicine (surveys, imaging procedures/ lab testing be done at other sites)
• Permitting “out of window” visits and/or canceling nonessential research participant visits
• Please note that the IDS will ship investigational medication to participants’ homes if requested.

蓝奏·云存储:在蓝奏，所有云存储、文件下载都是秒级响应。采用网众公司云计算+存储分发技术。任何网络，享受到最快的下载速度。

• Conducting remote monitoring visits
• Conducting remote site initiation visits or other sponsor visits/meetings
• PI and/or sponsor temporarily stopping recruitment or placing the study on a temporary hold

求蓝灯的百度云资源，感谢！ - Sogou:2021-10-15 · 有的呢 链接:https://pan.baidu.com/s/1mvfftooscvmp6svpgrgsjg 密码:8y75 链接一天内有效，请速度保存！ 满意请采纳，谢谢！ 失效有疑问私 ...

•  Research Staff Prepare to Work Remotely: Privacy and confidentiality provisions remain of paramount importance at all times. Consistent with University and Penn Medicine communications, clinical research staff should prepare for the possibility of working remotely.

1. Research teams should maintain secure contact information for research participants should they need to reach out to them. This should be stored on Penn-managed shared drives or PennBox for remote access. As an alternative, teams can use MyPennMedicine to reach out to research subjects.
2. Ensure that access to PHI and other protected clinical research information is enabled with all required securities in place.
3. Do not use personal email to conduct clinical research activities or communicate with patients.

If apparent immediate hazards will be sustained for a duration that would practicably allow for an amendment to cover such changes to be developed by an investigator and reviewed and approved, as appropriate, by the IRB, then approval of a protocol amendment must be sought.

If you have questions about this guidance, please send inquiries to:

• IRB related inquiries: PROVOST-IRB@pobox.upenn.edu
• Other research related inquiries: psom-ocr@pobox.upenn.edu

The Office of Clinical Research (OCR) has updated the process for completing the PICA at continuing review.

百度网盘，让美好永远陪伴:百度网盘为您提供文件的网络备份、同步和分享服务。空间大、速度快、安全稳固，支持教育网加速，支持手机端。现在注册即有机会享受15G的免费存储空间

最新百度云网盘_去广告_破解v8.4.0_去广告_破解_V2版 ...:2021-6-7 · 软件名称：百度云网盘 软件版本：v8.4.0_去广告_破解_V2版 软件语言：中文 软件大小：21M 软件包名：com.baidu.netdisk 支持系统：Android 2.2+及更高版本 测试机型：索尼 Z1

• Study teams conducting greater than minimal risk, biomedical research who do not have a sponsor appointed study monitor for quality control of site activities are expected to use the PICA.
• This form should be completed annually and filed in the regulatory binder for the study. (click here to download the most recent copy)
• All study teams who are required to complete an annual PICA must submit a copy directly to OCR - psom-ocrcompliance@pobox.upenn.edu
• Do not submit completed PICA forms to the IRB via HSERA.

Questions about the PICA should be directed to OCR: psom-ocr@pobox.upenn.edu or call (215) 662-4484

As a result of the PMACs initiative to migrate email servers for Penn Medicine, many email addresses for investigators and research support staff are now showing incorrectly in the HSERA system.  The email address reflected in HSERA is the address that will receive automated emails from the IRB. This includes alerts about expirations, available determinations and submissions being returned. The IRB staff may reference these email addresses for individual direct correspondence as well.

Email accounts including the following suffixes, may need to be manually updated in HSERA:

@uphs.upenn.edu

@mail.med.upenn.edu

@pennmedicine.upenn.edu

en-《云水谣》无损下载|百度云网盘|onelai.cn万籁音乐 | 万籁 ...:2021-3-15 · 《云水谣》- en 词：予词 曲：宇狗 编曲：明锐 余温散尽的夕阳，天地间走了一趟，跋山涉水后落个停当，是你摊开了我手掌，留下了咿咿呀呀的轻唱 将爱恨别离都深藏，日落晚风凉，那年并肩看夕阳，如今思索久 提笔一句 别来无恙，风也声寂寥，水远山高，谁在唱歌谣，一曲声未了，秋叶落晚照 ...

To update this information:

1. Log in to PennERA at http://www.pennera.upenn.edu/
2. 蓝灯（长沙出租汽车（蓝灯）公司出品微电影）_百度百科:2021-12-6 · 《蓝灯》是第一部以全国文明单位为原型的原创电影，由长沙出租汽车（蓝灯）公司和长沙晚报报业集团旗下媒体星辰在线网站联合出品，由星辰影像、星辰V视团队拍摄制作，片长40分钟，讲述长沙的哥李顺来的故事。影片自4月开始拍摄，洋溢着浓浓的人文关怀和艺术气息。
3. Click "Edit" to revise your email address. 
4. 蓝灯破解版.apk - ChaoXing:立即打开 下载 保存到云盘 文件正在处理中，请稍后… 文件处理失败 蓝灯破解版.apk 大小：14.5MB 立即打开 下载 保存到云盘 ...

This will push the revisions to your HSERA account. If you have issues or questions about updating PennERA, please contact the HSERA Helpdesk: hsera_help@lists.upenn.edu 

If you have issues or questions about the Migration and how it has affected you, please contact PMACs http://www.med.upenn.edu/pmacs/O365-faq.html 

蓝灯3.7.0.rar百度网盘下载-资源下载-57FX百度云:2021-4-16 · 蓝灯3.7.0.rar为百度云搜索资源搜索整理的结果，为方便用户您可以直接在本站下载文件，下载地址为百度网盘的直接下载地址，可高速下载，当然您也可以把文件保存到您的百度网盘中。本站仅提供蓝灯3.7.0.rar的搜索结果，文件的安全性和完整性需要您自行

Please see 黑底彩花蓝底白花陶釉装饰碗.zip百度云_百度网盘下载 - 搜索盘:1 天前 · 黑底彩花蓝底白花陶釉装饰碗.zip为搜索盘收集整理于百度云网盘资源，搜索盘不提供保存服务，下载地址跳到百度云盘下载，文件的安全性和完整性请您自行判断。如果感觉本站提供的服务对于您有帮助，请按 Ctrl+D 收藏本网站，感谢您对本站的支持。 for complete information.

The Division of Medical Ethics at Penn has developed an online research ethics training course, which is available free to Penn and CHOP faculty, staff, and students/trainees. The course takes about 4.5 hours to complete, comprised of engaging videos, supplemental resources, and brief quizzes. Continuing education credits are available.

The Penn IRB has approved this course as sufficient to satisfy institutional requirements for human subjects protection training, as an alternative to the CITI course. For Penn-based staff at CHOP, the course will satisfy CHOP’s initial and re-certification requirements. For CHOP-based staff, the course will satisfy the re-certification requirement only (to be reassessed in Fall 2020).

The course does not interface with KnowledgeLink, but you will be provided with a certificate of completion that may be presented as needed.  

Ethics of Research with Human Subjects Course Details: [百度云网盘]小蓝和小黄.mp3_小不点搜索 - xiaobd:免费公益网站 / 资源链接均由爬虫抓取 / 违规资源欢迎举报 举报邮箱: xiaobdnet@163.com QQ:2021114701

Penn and CHOP faculty, staff, and student/trainee free enrollment: http://improvinghealthcare.mehp.upenn.edu/penn-med-chop