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Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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EFGCP–EUCROF Joint Workshop Final Report   by GCP HelpDesk on 2010-08-20 12:12:20
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by GCP HelpDesk on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by GCP HelpDesk on 2010-06-13 10:07:59
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by GCP HelpDesk on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by GCP HelpDesk on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by GCP HelpDesk on 2010-05-01 01:40:32
Major developments in EU Clinical Trial Guidances   by GCP HelpDesk on 2010-04-20 19:10:55
CONSORT III (2010)   by GCP HelpDesk on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by GCP HelpDesk on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by GCP HelpDesk on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by GCP HelpDesk on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by GCP HelpDesk on 2010-02-06 12:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by GCP HelpDesk on 2010-01-27 11:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by GCP HelpDesk on 2010-01-22 10:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by GCP HelpDesk on 2010-01-21 11:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by GCP HelpDesk on 2010-01-13 20:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by GCP HelpDesk on 2010-01-12 12:15:13
EMEA Guidelines on Cystic Fibrosis Drug Development   by GCP HelpDesk on 2010-01-05 09:14:16
US-FDA' proposed rule on Informed Consent regulations   by GCP HelpDesk on 2010-01-02 22:22:47
International Compilation of Human Research Protections 2010 Edition   by GCP HelpDesk on 2009-12-23 14:59:39
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by GCP HelpDesk on 2009-12-17 19:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by GCP HelpDesk on 2009-12-04 18:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by GCP HelpDesk on 2009-11-30 10:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by GCP HelpDesk on 2009-11-21 07:57:50
Companies to Disclose All Clinical Trials in Patients   by GCP HelpDesk on 2009-11-19 09:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by GCP HelpDesk on 2009-11-09 09:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by GCP HelpDesk on 2009-11-08 22:28:30
PhRMA's New Clinical Trial Guidelines   by GCP HelpDesk on 2009-10-05 10:21:30
«StartPrev123NextEnd»
 Ethics, GCP, Quality Assurance and Regulatory Affairs
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0 40182 by GCP HelpDesk
on 2010-08-20 12:12:20
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0 36662 by GCP HelpDesk
on 2010-06-13 10:11:41
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by GCP HelpDesk on 2010-06-13 10:07:59
0 35858 by GCP HelpDesk
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by GCP HelpDesk on 2010-05-27 11:42:00
0 8222 by GCP HelpDesk
on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population
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0 7554 by GCP HelpDesk
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by GCP HelpDesk on 2010-04-30 22:35:05
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Major developments in EU Clinical Trial Guidances
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0 7277 by GCP HelpDesk
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Deming's 14 Principles-Aricle from BARQA
by Leon on 2010-04-18 22:32:54
0 2740 by Leon
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CONSORT III (2010)
by GCP HelpDesk on 2010-03-29 12:53:28
0 6839 by GCP HelpDesk
on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function
by GCP HelpDesk on 2010-03-20 12:25:16
0 6361 by GCP HelpDesk
on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials
by GCP HelpDesk on 2010-03-04 14:07:46
0 7682 by GCP HelpDesk
on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data
by GCP HelpDesk on 2010-02-25 20:47:33
0 6949 by GCP HelpDesk
on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
by GCP HelpDesk on 2010-02-06 12:12:14
0 6168 by GCP HelpDesk
on 2010-02-06 12:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive
by GCP HelpDesk on 2010-01-27 11:19:01
0 5537 by GCP HelpDesk
on 2010-01-27 11:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT
by GCP HelpDesk on 2010-01-22 10:07:03
0 6753 by GCP HelpDesk
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US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies
by GCP HelpDesk on 2010-01-21 11:22:51
0 5601 by GCP HelpDesk
on 2010-01-21 11:22:51
FDA Issues Draft Guidance on IRB Continuing Review
by GCP HelpDesk on 2010-01-13 20:07:29
0 5461 by GCP HelpDesk
on 2010-01-13 20:07:29
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EMEA Guidelines on Cystic Fibrosis Drug Development
by GCP HelpDesk on 2010-01-05 09:14:16
0 7488 by GCP HelpDesk
on 2010-01-05 09:14:16
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