This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers.
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Bitesize GCP | bitesizegcp.blogspot.com Reviews
https://bitesizegcp.blogspot.com
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers.
bitesizegcp.blogspot.com
Bitesize GCP: Declaring recruitment potential in feasibility
http://bitesizegcp.blogspot.com/2011/01/declaring-recruitment-potential-in.html
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Monday, 10 January 2011. Declaring recruitment potential in feasibility. Cutting to the chase, feasibility is all about determining the potential for trial subject recruitment in a set time frame. The expectation is that 5/6 patients can be hoped for. To set expectations to?
Bitesize GCP: Does an Investigator have to be a Physician?
http://bitesizegcp.blogspot.com/2010/12/does-investigator-have-to-be-physician.html
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Monday, 27 December 2010. Does an Investigator have to be a Physician? Labels: 21 CFR 312.53(a). Subscribe to: Post Comments (Atom). View my complete profile. IN THE POSTINGS, INVESTIGATORS ARE REFERRED TO AS MASCULINE, RESEARCH NURSES AS FEMININE.
Bitesize GCP: Minimum Qualifications of an Investigator
http://bitesizegcp.blogspot.com/2011/01/minimum-qualifications-of-investigator.html
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Monday, 3 January 2011. Minimum Qualifications of an Investigator. It may well be part of a Sponsor´s SOPs to only select physicians as investigators. That certainly is within their rights. It is good, however, for sponsor staff to realise that this is a compan...For 7 year...
Bitesize GCP: ICH-GCP training of site staff
http://bitesizegcp.blogspot.com/2011/01/ich-gcp-training-of-site-staff.html
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Monday, 31 January 2011. ICH-GCP training of site staff. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (PI) (1.34). Which brings us to golden standard....
Bitesize GCP: The Informed Consent Process I - The start of a Series
http://bitesizegcp.blogspot.com/2011/02/informed-consent-process-i-start-of.html
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Wednesday, 9 February 2011. The Informed Consent Process I - The start of a Series. It is absolutely crucial to distinguish well between the two. Here is the core of the difference:. Medical practice Informed Consent. Clinical Research Informed Consent. Industry representat...
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clinicalresearchweekly.blogspot.com
Clinical Research Weekly: December 2009
http://clinicalresearchweekly.blogspot.com/2009_12_01_archive.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Tuesday, 8 December 2009. EMEA and FDA strengthen collaboration on inspections. It concerns a pilot phase of 18 months, after which a joint assessment will lead to modifications and amendments to the scope and process, as needed. The key objectives are:. To conduct periodic information exchanges on GCP-related information. To conduct collaborative GCP inspections. The two...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: EMEA and FDA strengthen collaboration on inspections
http://clinicalresearchweekly.blogspot.com/2009/12/emea-and-fda-strengthen-collaboration.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Tuesday, 8 December 2009. EMEA and FDA strengthen collaboration on inspections. It concerns a pilot phase of 18 months, after which a joint assessment will lead to modifications and amendments to the scope and process, as needed. The key objectives are:. To conduct periodic information exchanges on GCP-related information. To conduct collaborative GCP inspections. The two...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: FDA Basics for Industry
http://clinicalresearchweekly.blogspot.com/2011/01/fda-basics-for-industry.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Monday, 10 January 2011. FDA Basics for Industry. Over the last week, the FDA launched a new section of their website, called 'FDA Basics for Industry'. The website includes basic information about the regulatory process, including information that is frequently requested by industry.". Labels: Basics for Industry. Subscribe to: Post Comments (Atom). Eric Klaver has worke...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: 1572 in International Setting
http://clinicalresearchweekly.blogspot.com/2010/12/1572-in-international-setting.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Monday, 27 December 2010. 1572 in International Setting. There has been ample discussion on the FDA1572 and its use in international research. The FDA has provided some useful guidance this year. Some highlights from that today. Local Law vs CFR. Signing of the 1572 by a foreign investigator in a study under IND. Subscribe to: Post Comments (Atom). For 7 years, Eric ran h...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: Questionable research removed from record as Lancet retracts publication
http://clinicalresearchweekly.blogspot.com/2011/01/british-medical-journal-bmj-this-month.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Tuesday, 18 January 2011. Questionable research removed from record as Lancet retracts publication. The British Medical Journal (BMJ) this month (January 5th) has published an article. The article, by Brian Deer, a journalist, is titled " How the case against the MMR vaccine was fixed. Although it is somewhat understandable that someone does not want to let go of somethin...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: A True Investigator Meeting
http://clinicalresearchweekly.blogspot.com/2011/01/true-investigator-meeting.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Monday, 3 January 2011. A True Investigator Meeting. Today I would like to draw your attention to a thought provoking column in the December issue of The Monitor. The publication of the Association of Clinical Research Professionals (ACRP). Dr. Joel S. Ross, MD, entitled his column "Investigating Investigator Meetings" (Page 84-85). In this blog, I would like to add my pe...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: January 2011
http://clinicalresearchweekly.blogspot.com/2011_01_01_archive.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Tuesday, 18 January 2011. Questionable research removed from record as Lancet retracts publication. The British Medical Journal (BMJ) this month (January 5th) has published an article. The article, by Brian Deer, a journalist, is titled " How the case against the MMR vaccine was fixed. Although it is somewhat understandable that someone does not want to let go of somethin...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: The FDA and the Declaration of Helsinki
http://clinicalresearchweekly.blogspot.com/2010/06/fda-and-declaration-of-helsinki.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Thursday, 3 June 2010. The FDA and the Declaration of Helsinki. It's not new, however awareness of the following is not yet all that wide-spread. The FDA has abandoned the Declaration of Helsinki. Where proven interventions had become established. In the Declaration of Helsinki 2000, the WMA states that investigational products ". Be tested against those of the best curre...
clinicalresearchweekly.blogspot.com
Clinical Research Weekly: New version of EudraGMP allows access to information from all Member States
http://clinicalresearchweekly.blogspot.com/2011/02/new-version-of-eudragmp-allows-access.html
The Clinical Research Weekly blog aims to provide Clinical Research Professionals with short pieces of news and information each week. Wednesday, 9 February 2011. New version of EudraGMP allows access to information from all Member States. Is the name for the Community database on manufacturing and import authorisations and Good Manufacturing Practice (GMP) certificates. The latest version of the database allows public access to the authorisation and GMP certificates coming from all countries in the EEA,...
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Bitesize GCP
This blog is intended to provide bitesize pieces of ICH-GCP (E6). Small,snappy pieces. What does ICH-GCP say, how does that impact, what does that mean. Please feel free to request topics or ask for opinions of the author and readers. Wednesday, 9 February 2011. The Informed Consent Process I - The start of a Series. It is absolutely crucial to distinguish well between the two. Here is the core of the difference:. Medical practice Informed Consent. Clinical Research Informed Consent. Industry representat...
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HkFashionGeek's personal life in bite size pieces. Personal musings from Virginia, also known as the Co-Founder of Hong Kong Fashion Geek (http:/ hkfashiongeek.com). April 17, 2017. Yummy brunch to wind down the long Easter weekend… (at The Continental). April 15, 2017. Blink and you miss it…. March 14, 2017. An attempt at crocheting a mandala. February 28, 2017. February 21, 2017. OT dinner done right. #sikfaanfriday. February 17, 2017. February 17, 2017. January 21, 2017. January 20, 2017. Page 1 of 208.
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