�ݺ�ߣshows by User: QcustomerR

�ݺ�ߣshows by User: QcustomerR / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: QcustomerR / Tue, 09 Jun 2015 21:29:18 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: QcustomerR Webinar: Embracing Social Media in Research /slideshow/quorum-review-webinar-embracing-social-media-in-research/49193952 quorumreviewwebinarembracingsocialmediainresearch-150609212919-lva1-app6892
Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.]]>
Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.]]> Tue, 09 Jun 2015 21:29:18 GMT /slideshow/quorum-review-webinar-embracing-social-media-in-research/49193952 QcustomerR@slideshare.net(QcustomerR) Webinar: Embracing Social Media in Research QcustomerR Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/quorumreviewwebinarembracingsocialmediainresearch-150609212919-lva1-app6892-thumbnail.jpg?width=120&height=120&fit=bounds" /> Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.

Webinar: Embracing Social Media in Research from Quorum Review - Independent Review Board

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1 Webinar: Reviewing Research Involving Medical Devices /slideshow/webinar-reviewing-research-involving-medical-devices/39538102 qirbmedicaldevicewebinar2014-140925153637-phpapp02
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.]]>
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.]]> Thu, 25 Sep 2014 15:36:37 GMT /slideshow/webinar-reviewing-research-involving-medical-devices/39538102 QcustomerR@slideshare.net(QcustomerR) Webinar: Reviewing Research Involving Medical Devices QcustomerR Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/qirbmedicaldevicewebinar2014-140925153637-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.

Webinar: Reviewing Research Involving Medical Devices from Quorum Review - Independent Review Board

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1 Understanding Reporting Obligatins to the IRB /slideshow/webinar-understandingreportingobligationstotheirbfinalsmallpdf/34777263 webinar-understanding-reporting-obligations-to-the-irb-final-smallpdf-140516131956-phpapp02
Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.]]>
Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.]]> Fri, 16 May 2014 13:19:56 GMT /slideshow/webinar-understandingreportingobligationstotheirbfinalsmallpdf/34777263 QcustomerR@slideshare.net(QcustomerR) Understanding Reporting Obligatins to the IRB QcustomerR Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/webinar-understanding-reporting-obligations-to-the-irb-final-smallpdf-140516131956-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.

Understanding Reporting Obligatins to the IRB from Quorum Review - Independent Review Board

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1 Institution Bulletin: Volume 4 Issue 2 /slideshow/institution-bulletin-volume-4-issue-2/33867492 institutionbulletinvolume4issue2-140423154502-phpapp01
Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.]]>
Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.]]> Wed, 23 Apr 2014 15:45:02 GMT /slideshow/institution-bulletin-volume-4-issue-2/33867492 QcustomerR@slideshare.net(QcustomerR) Institution Bulletin: Volume 4 Issue 2 QcustomerR Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume4issue2-140423154502-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.

Institution Bulletin: Volume 4 Issue 2 from Quorum Review - Independent Review Board

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1 eConsent for Research /QcustomerR/e-consent20for20research-04142014finalsmall econsent20for20research04-14-2014-finalsmall-140421180844-phpapp01
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]]> Mon, 21 Apr 2014 18:08:44 GMT /QcustomerR/e-consent20for20research-04142014finalsmall QcustomerR@slideshare.net(QcustomerR) eConsent for Research QcustomerR <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/econsent20for20research04-14-2014-finalsmall-140421180844-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" />

eConsent for Research from Quorum Review - Independent Review Board

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1 What is the Sunshine Act? /slideshow/sunshine-act-33617757/33617757 sunshineact-140416160731-phpapp02
Sunshine Act Reporting and your IRB Members.]]>
Sunshine Act Reporting and your IRB Members.]]> Wed, 16 Apr 2014 16:07:31 GMT /slideshow/sunshine-act-33617757/33617757 QcustomerR@slideshare.net(QcustomerR) What is the Sunshine Act? QcustomerR Sunshine Act Reporting and your IRB Members. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sunshineact-140416160731-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Sunshine Act Reporting and your IRB Members.

What is the Sunshine Act? from Quorum Review - Independent Review Board

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1 Webinar �ݺ�ߣs: Biobanking & Future Research: Addressing the "Unknown" in the Protocol and Consent /slideshow/webinar-slides-biobanking-future-research-addressing-the-unknown-in-the-protocol-and-consent/31866177 biobankingfutureresearchpdf-140303180926-phpapp01
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants.]]>
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants.]]> Mon, 03 Mar 2014 18:09:26 GMT /slideshow/webinar-slides-biobanking-future-research-addressing-the-unknown-in-the-protocol-and-consent/31866177 QcustomerR@slideshare.net(QcustomerR) Webinar �ݺ�ߣs: Biobanking & Future Research: Addressing the "Unknown" in the Protocol and Consent QcustomerR Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/biobankingfutureresearchpdf-140303180926-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants.

Webinar �ݺ�ߣs: Biobanking & Future Research: Addressing the "Unknown" in the Protocol and Consent from Quorum Review - Independent Review Board

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1 Institution Bulletin: Volume 4 Issue 1 /slideshow/institution-bulletin-volume-4-issue-1/31100901 institutionbulletinvolume4issue1-140211181206-phpapp02
Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.]]>
Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.]]> Tue, 11 Feb 2014 18:12:05 GMT /slideshow/institution-bulletin-volume-4-issue-1/31100901 QcustomerR@slideshare.net(QcustomerR) Institution Bulletin: Volume 4 Issue 1 QcustomerR Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume4issue1-140211181206-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.

Institution Bulletin: Volume 4 Issue 1 from Quorum Review - Independent Review Board

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1 Institution Bulletin: Volume 3, Issue 4 /slideshow/institution-bulletin-volume-3-issue-4/27299052 institutionbulletinvolume3issue4-131017100812-phpapp02
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.]]>
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.]]> Thu, 17 Oct 2013 10:08:11 GMT /slideshow/institution-bulletin-volume-3-issue-4/27299052 QcustomerR@slideshare.net(QcustomerR) Institution Bulletin: Volume 3, Issue 4 QcustomerR Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume3issue4-131017100812-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.

Institution Bulletin: Volume 3, Issue 4 from Quorum Review - Independent Review Board

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1 Webinar: Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent /slideshow/webinar-26283404/26283404 subjectswithlimitedcapacityinteractive-130917152603-phpapp02
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.]]>
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.]]> Tue, 17 Sep 2013 15:26:03 GMT /slideshow/webinar-26283404/26283404 QcustomerR@slideshare.net(QcustomerR) Webinar: Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent QcustomerR Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/subjectswithlimitedcapacityinteractive-130917152603-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.

Webinar: Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent from Quorum Review - Independent Review Board

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1 Defining Human Research /slideshow/defining-2013c-august/25210801 defining2013caugust-130813111731-phpapp02
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]]> Tue, 13 Aug 2013 11:17:31 GMT /slideshow/defining-2013c-august/25210801 QcustomerR@slideshare.net(QcustomerR) Defining Human Research QcustomerR <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/defining2013caugust-130813111731-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" />

Defining Human Research from Quorum Review - Independent Review Board

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1 Institution bulletin volume 3 issue 3 /slideshow/institution-bulletin-volume-3-issue-3/24625120 institutionbulletinvolume3issue3-130725130714-phpapp01
Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.]]>
Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.]]> Thu, 25 Jul 2013 13:07:14 GMT /slideshow/institution-bulletin-volume-3-issue-3/24625120 QcustomerR@slideshare.net(QcustomerR) Institution bulletin volume 3 issue 3 QcustomerR Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume3issue3-130725130714-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.

Institution bulletin volume 3 issue 3 from Quorum Review - Independent Review Board

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1 E consent for research: Considerations in Implementation and IRB Review /slideshow/e-consent-for-research-considerations-and-irb-review/23479785 econsentforresearch-130625161614-phpapp02
Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider when evaluating the use of eConsent for a given study. With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation. ]]>
Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider when evaluating the use of eConsent for a given study. With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation. ]]> Tue, 25 Jun 2013 16:16:14 GMT /slideshow/e-consent-for-research-considerations-and-irb-review/23479785 QcustomerR@slideshare.net(QcustomerR) E consent for research: Considerations in Implementation and IRB Review QcustomerR Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider when evaluating the use of eConsent for a given study. With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/econsentforresearch-130625161614-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider when evaluating the use of eConsent for a given study. With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation.

E consent for research: Considerations in Implementation and IRB Review from Quorum Review - Independent Review Board

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1 What is an IRB? /QcustomerR/what-is-an-irb irbinfographic2-130523151838-phpapp01
Info graphic on What is an IRB?]]>
Info graphic on What is an IRB?]]> Thu, 23 May 2013 15:18:38 GMT /QcustomerR/what-is-an-irb QcustomerR@slideshare.net(QcustomerR) What is an IRB? QcustomerR Info graphic on What is an IRB? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/irbinfographic2-130523151838-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Info graphic on What is an IRB?

What is an IRB? from Quorum Review - Independent Review Board

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1 Defining Human Research /slideshow/quorum-review-defining-human-research-21620310/21620310 quorumreview-defininghumanresearch-130521133356-phpapp02
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Defining Human Research from Quorum Review - Independent Review Board

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1 Quorum Review Institution Bulletin V3, iss2 /slideshow/institution-bulletin-volume-3-issue-2q2/20751346 institutionbulletinvolume3issue2q2-130507162405-phpapp01
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.]]>
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.]]> Tue, 07 May 2013 16:24:05 GMT /slideshow/institution-bulletin-volume-3-issue-2q2/20751346 QcustomerR@slideshare.net(QcustomerR) Quorum Review Institution Bulletin V3, iss2 QcustomerR Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume3issue2q2-130507162405-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.

Quorum Review Institution Bulletin V3, iss2 from Quorum Review - Independent Review Board

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1 IRB Evaluation of Advertisements, Consent Forms and Study Tools /slideshow/irb-evaluation-of-advertisements-consent-forms-and-study-tools-17110992/17110992 advertisementsandconsentformswebinarfinal-130311133104-phpapp02
Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB. Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.]]>
Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB. Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.]]> Mon, 11 Mar 2013 13:31:03 GMT /slideshow/irb-evaluation-of-advertisements-consent-forms-and-study-tools-17110992/17110992 QcustomerR@slideshare.net(QcustomerR) IRB Evaluation of Advertisements, Consent Forms and Study Tools QcustomerR Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB. Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/advertisementsandconsentformswebinarfinal-130311133104-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB. Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.

IRB Evaluation of Advertisements, Consent Forms and Study Tools from Quorum Review - Independent Review Board

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1 Quorum Review Institution Bulletin v3, iss1 /slideshow/quorum-review-institution-bulletin-v3-iss1/16239910 institutionbulletinvolume3issue1-130129101725-phpapp02
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.]]>
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.]]> Tue, 29 Jan 2013 10:17:25 GMT /slideshow/quorum-review-institution-bulletin-v3-iss1/16239910 QcustomerR@slideshare.net(QcustomerR) Quorum Review Institution Bulletin v3, iss1 QcustomerR Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionbulletinvolume3issue1-130129101725-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.

Quorum Review Institution Bulletin v3, iss1 from Quorum Review - Independent Review Board

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1 Navigating Research in Pediatric Populations /slideshow/navigating-research-in-pediatric-populations/14804511 pediatricresearchwebinar10oct2012final-121019125146-phpapp02
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically. ]]>
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically. ]]> Fri, 19 Oct 2012 12:51:45 GMT /slideshow/navigating-research-in-pediatric-populations/14804511 QcustomerR@slideshare.net(QcustomerR) Navigating Research in Pediatric Populations QcustomerR When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pediatricresearchwebinar10oct2012final-121019125146-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.

Navigating Research in Pediatric Populations from Quorum Review - Independent Review Board

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1 Institution newsletter Volume 2 Issue 3 /slideshow/institution-newsletter-volume-2-issue-3-13842437/13842437 institutionnewsletter-volume2issue3-120802140216-phpapp02
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]]> Thu, 02 Aug 2012 14:02:15 GMT /slideshow/institution-newsletter-volume-2-issue-3-13842437/13842437 QcustomerR@slideshare.net(QcustomerR) Institution newsletter Volume 2 Issue 3 QcustomerR <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/institutionnewsletter-volume2issue3-120802140216-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" />

Institution newsletter Volume 2 Issue 3 from Quorum Review - Independent Review Board

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1 https://cdn.slidesharecdn.com/profile-photo-QcustomerR-48x48.jpg?cb=1523313325 A sustained passion for performance.  The founders of Quorum Review IRB believed that an IRB did not have to sacrifice customer service to provide a thorough review. They knew they must build a high-performance IRB. So in 1992, that’s what they set out to do. Since then, Quorum has relentlessly pursued better ways to deliver IRB services—for research participants, sponsors and CROs alike. At Quorum, performance is in our DNA, and throughout our history, we’ve innovated to simplify and streamline for participants, sites and sponsors alike. Quorum is the IRB of choice when performance matters, and to us it always does. www.quorumreview.com/ https://cdn.slidesharecdn.com/ss_thumbnails/quorumreviewwebinarembracingsocialmediainresearch-150609212919-lva1-app6892-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/quorum-review-webinar-embracing-social-media-in-research/49193952 Webinar: Embracing Soc... https://cdn.slidesharecdn.com/ss_thumbnails/qirbmedicaldevicewebinar2014-140925153637-phpapp02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/webinar-reviewing-research-involving-medical-devices/39538102 Webinar: Reviewing Res... https://cdn.slidesharecdn.com/ss_thumbnails/webinar-understanding-reporting-obligations-to-the-irb-final-smallpdf-140516131956-phpapp02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/webinar-understandingreportingobligationstotheirbfinalsmallpdf/34777263 Understanding Reportin...