Follow us on

Q of the week

Q: How Do You Get Shingles?

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.
 Forums
Board Index Latest Posts Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by GCP HelpDesk on 2010-08-20 20:12:20
Managing Clinical Trials   by GCP HelpDesk on 2010-07-16 00:05:32
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
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by GCP HelpDesk on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by GCP HelpDesk on 2010-06-03 17:27:58
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
The Wall Street Journal's special supplement on clinical trials   by GCP HelpDesk on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by GCP HelpDesk on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by GCP HelpDesk on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by GCP HelpDesk on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by GCP HelpDesk on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by GCP HelpDesk on 2010-04-05 04:52:16
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US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by GCP HelpDesk on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by GCP HelpDesk on 2010-03-04 22:07:46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
PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer   by GCP HelpDesk on 2010-01-11 04:23:31
PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS   by GCP HelpDesk on 2010-01-11 04:00:18
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
US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by GCP HelpDesk on 2009-12-31 17:10:00
International Compilation of Human Research Protections 2010 Edition   by GCP HelpDesk on 2009-12-23 22:59:39
ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials   by GCP HelpDesk on 2009-12-18 04:11:05
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
 General
Forums Topics Posts Last Post
General Category
Here you will find periodic announcements from the moderators and advisors of GCP HelpDesk Forum. 		3 1 by GCP HelpDesk
on 2009-09-15 20:31:57
 Career and Jobs Board
Forums Topics Posts Last Post
Career Discussion
This is completely unrestricted area and we encourage you to use this as much as you can. 		5 3 by william
on 2012-08-31 15:48:02
Jobs in INDIA
3 1 by Leon
on 2010-07-16 18:58:12
Jobs in NORTH AMERICA
0 0
Jobs in EUROPE
2 0 by Karina
on 2010-02-12 00:41:09
Jobs in AFRICA
0 0
Jobs in other ASIA and ASIA-PACIFIC
0 0
Jobs in LATIN AMERICA
0 0
 GCP, Quality Assurance and Regulatory Affairs
Forums Topics Posts Last Post
Ethics, GCP, Quality Assurance and Regulatory Affairs
This is the place to discuss ethics, informed consent related issues, ICH-GCP and any other guidelines, Quality Assurance and Regulatory aspects. 		47 33 by william
on 2012-08-31 15:44:05
Regulatory/FDA Warning and Notice of Violation Letters to Pharmaceutical Companies
1 0 by GCP HelpDesk
on 2009-12-31 17:10:00
 Clinical Operations
Forums Topics Posts Last Post
Clinical Operations
This is the discussion area for the Clinical Investigators, CRCs, CRAs and other professionals on their day to day management of their Clinical Research issues including the topics relevant to Biometrics, Biostatistics, Clinical Data Management, Pharmacovigilance and BA/BE studies. 		31 39 by Dino Brand
on 2011-12-27 01:18:25
Clinical Research/Trials Updates
Forum discussing news, current events and important topical issues of the day. 		16 1 by Leon
on 2010-11-10 23:18:22
Project Management
Here you will find advice and solutions through the discussions to many of the problems facing the Project Managers in Clinical Research Community. It has been specially-designed to create the unique opportunity of discussions offering cross-industry, cross-platform, and cross-cultural insights into PM-related problems and their solutions. 		1 1 by Savitha
on 2009-10-15 00:10:59
Clinical Research Milestones
Discussion forum intended for history of clinical research and medicine across a wide variety of periods and regions of the world. While rooted in history, ours is truly an interdisciplinary field, bringing together complementary theories and methodologies from across the Biomedical/Medical Sciences and Pharmaceutical/Life Sciences. 		3 0 by Harrison
on 2009-12-17 22:31:54
Biometrics
Discussion Group for biometrics and clinical data management for the exchange of information and ideas. 		1 0 by GCP HelpDesk
on 2010-08-24 20:11:51
Medicine, Pharmacology & Therapeutics updates
Forum for discussion of updates in pharmacology and therapeutics relevant to clinical research. This can be used for education, discussion, collaboration, sharing ideas, general announcements and the dissemination of pharmacological research across the world. And welcomes messages relating to conferences, fellowships and research help or offer. 		33 0 by Tonny Johnson
on 2012-01-16 20:45:14
Clinical Research Grants/Fellowships/Awards
0 0
Pharmacovigilance and Drug Safety
3 0 by GCP HelpDesk
on 2010-06-03 17:27:58
 IPR and Patent issues
Forums Topics Posts Last Post
Patent News
4 0 by Sree
on 2010-01-12 00:54:48
 Anything and Everything
Forums Topics Posts Last Post
Anything and Everything
Any topic that does not fit under any other category should be discussed here. 		38 28 by William Jimenez
on 2012-03-16 08:43:41
 Drug Discovery
Forums Topics Posts Last Post
Drug Discovery
This Forum provides a unique opportunity to discuss about drug development in Pipeline 		3 0 by Tonny Johnson
on 2010-12-17 15:47:48

Powered by ccBoard