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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 20:12:20
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by GCP HelpDesk on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by GCP HelpDesk on 2010-06-13 18:07:59
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by GCP HelpDesk on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by GCP HelpDesk on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by GCP HelpDesk on 2010-05-01 09:40:32
Major developments in EU Clinical Trial Guidances   by GCP HelpDesk on 2010-04-21 03:10:55
CONSORT III (2010)   by GCP HelpDesk on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by GCP HelpDesk on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by GCP HelpDesk on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by GCP HelpDesk on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by GCP HelpDesk on 2010-02-06 20:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by GCP HelpDesk on 2010-01-27 19:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by GCP HelpDesk on 2010-01-22 18:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by GCP HelpDesk on 2010-01-21 19:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by GCP HelpDesk on 2010-01-14 04:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by GCP HelpDesk on 2010-01-12 20:15:13
EMEA Guidelines on Cystic Fibrosis Drug Development   by GCP HelpDesk on 2010-01-05 17:14:16
US-FDA' proposed rule on Informed Consent regulations   by GCP HelpDesk on 2010-01-03 06:22:47
International Compilation of Human Research Protections 2010 Edition   by GCP HelpDesk on 2009-12-23 22:59:39
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by GCP HelpDesk on 2009-12-18 03:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by GCP HelpDesk on 2009-12-05 02:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by GCP HelpDesk on 2009-11-30 18:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by GCP HelpDesk on 2009-11-21 15:57:50
Companies to Disclose All Clinical Trials in Patients   by GCP HelpDesk on 2009-11-19 17:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by GCP HelpDesk on 2009-11-09 17:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by GCP HelpDesk on 2009-11-09 06:28:30
PhRMA's New Clinical Trial Guidelines   by GCP HelpDesk on 2009-10-05 18:21:30
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 Ethics, GCP, Quality Assurance and Regulatory Affairs
Topics Replies Views Last Post
US-FDA' proposed rule on Informed Consent regulations
by GCP HelpDesk on 2010-01-03 06:22:47 		0 5072 by GCP HelpDesk
on 2010-01-03 06:22:47
International Compilation of Human Research Protections 2010 Edition
by GCP HelpDesk on 2009-12-23 22:59:39 		0 4117 by GCP HelpDesk
on 2009-12-23 22:59:39
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures
by GCP HelpDesk on 2009-12-18 03:21:16 		0 5158 by GCP HelpDesk
on 2009-12-23 22:12:04
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP
by GCP HelpDesk on 2009-12-05 02:55:35 		0 3590 by GCP HelpDesk
on 2009-12-05 03:14:15
Ethical Guidelines for Intervention Studies in New Zealand
by GCP HelpDesk on 2009-11-30 18:28:34 		0 5523 by GCP HelpDesk
on 2009-11-30 18:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance
by GCP HelpDesk on 2009-11-21 15:57:50 		0 4663 by GCP HelpDesk
on 2009-11-21 16:00:42
Companies to Disclose All Clinical Trials in Patients
by GCP HelpDesk on 2009-11-19 17:25:20 		0 5073 by GCP HelpDesk
on 2009-11-20 17:55:53
Office for Human Research Protections (OHRP): Requests for Public Comment
by GCP HelpDesk on 2009-11-09 17:38:15 		0 3596 by GCP HelpDesk
on 2009-11-09 18:43:05
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research
by GCP HelpDesk on 2009-11-09 06:28:30 		0 3374 by GCP HelpDesk
on 2009-11-09 06:28:30
FDA Issues Final Guidance on Investigator Responsibilities
by Leon on 2009-10-30 18:00:07 		0 1950 by Leon
on 2009-10-30 19:39:40
Vendor Quality Assurance Audits - A formula for Success
by Savitha on 2009-10-26 20:43:49 		0 4048 by Savitha
on 2009-10-26 20:43:49
Avoid common mistakes when dealing with IRB/IEC
by M.Anusha on 2009-10-26 18:26:01 		0 2110 by M.Anusha
on 2009-10-26 18:26:01
PhRMA's New Clinical Trial Guidelines
by GCP HelpDesk on 2009-10-05 18:21:30 		2 11019 by Sree
on 2009-10-26 18:00:00
Metrics for Quality Assurance Departments
by prasad.devani on 2009-10-20 20:32:40 		0 2196 by prasad.devani
on 2009-10-20 20:33:18
Modified Biomedical Research Bill to be presented in Parliament shortly
by Savitha on 2009-10-20 18:16:28 		0 1913 by Savitha
on 2009-10-20 18:16:28
GCP manual for Investigators
by Savitha on 2009-10-19 22:47:49 		0 2504 by Savitha
on 2009-10-19 22:47:49
AAHRPP Issues Final Revised Accreditation Standards
by Sree  on 2009-10-05 19:54:00 		0 2087 by Sree
on 2009-10-05 19:54:00
MHRA GCP inspections metrics report
by GCP HelpDesk on 2009-09-01 22:15:48 		0 2365 by GCP HelpDesk
on 2009-09-01 22:15:48
Applications invited for certification of quality and non-clinical data for ATMPs developed by SMEs
by GCP HelpDesk on 2009-09-01 22:12:43 		0 1595 by GCP HelpDesk
on 2009-09-01 22:12:43
New EMEA guideline on Co-ordination of Inspections
by GCP HelpDesk on 2009-09-01 22:00:03 		0 2050 by GCP HelpDesk
on 2009-09-01 22:00:39
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