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Harrison IRB Company Blog

Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9. The following q...

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Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9. The following q...
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Harrison IRB Company Blog | harrisonirb.blogspot.com Reviews

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Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9. The following q...

INTERNAL PAGES

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1

Harrison IRB Company Blog: Central Independent Review Boards and Community Attitudes

http://harrisonirb.blogspot.com/2012/03/central-independent-review-boards-and.html

Harrison IRB Company Blog. Thursday, March 29, 2012. Central Independent Review Boards and Community Attitudes. The Food and Drug Administration (FDA) requires an Independent Review Board (IRB) to consider "community attitudes" during its review of research. So what is the FDA's definition of "community attitude" and how can a central IRB have knowledge of a location's attitudes towards research when it reviews submissions from other cities, states or countries? Labels: 21 CFR 56.107. 21 CFR 56.111.

2

Harrison IRB Company Blog: March 2011

http://harrisonirb.blogspot.com/2011_03_01_archive.html

Harrison IRB Company Blog. Saturday, March 12, 2011. This month marks the two year anniversary of the GAO sting that resulted in one large independent review board's demise. And now another fraudulent research submission? Subscribe to: Posts (Atom). View my complete profile. Picture Window template. Powered by Blogger.

3

Harrison IRB Company Blog: FDA Revises Informed Consent Form Requirements

http://harrisonirb.blogspot.com/2012/03/fda-revises-informed-consent-form.html

Harrison IRB Company Blog. Wednesday, March 7, 2012. FDA Revises Informed Consent Form Requirements. The FDA has updated regulations that require additional language to informed consent form (ICF) documentation. 21 CFR 50.25(c) was updated on January 4, 2012 requiring that the informed consent document disclose the sponsor’s posting of clinical trial information on. The deadline for this change will take place for applicable studies that are initiated on or before March 7, 2012. Subscribe to: Post Commen...

4

Harrison IRB Company Blog: Witness Line on the Informed Consent Document

http://harrisonirb.blogspot.com/2012/04/witness-line-on-informed-consent.html

Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9. Picture Window ...

5

Harrison IRB Company Blog: April 2012

http://harrisonirb.blogspot.com/2012_04_01_archive.html

Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9.

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Harrison IRB Company Blog

Harrison IRB Company Blog. Tuesday, April 3, 2012. Witness Line on the Informed Consent Document. Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign? So, what exactly is the role of the witness? GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:. The witness must be impartial. The witness dates his/her signature. Labels: 21 CFR 50.27. 45 CFR 46.117. ICH E6 4.6.9. The following q...

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Harrison IRB

The Role of Harrison IRB. Harrison IRB is an accredited, independent review board that provides ethical review of research for the pharmaceutical, biotech, device, diagnostics and contract research industry. Harrison IRB reviews research in a timely manner while ensuring the adherence to regulatory and ethical review requirements. Benefits of Working With Harrison IRB:. Quick Links to Forms. Site Submission Form (SSF). Waiver of IRB Jurisdiction. Online, Secure, IRB data review system (24/7 access).

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