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  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
 Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results:.. 2009-12-05 03:14:15 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Subject :New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP

Dear All,
 
Here is the new GPP2 Guidelines on reporting Industry-Supported Clinical Trial Results.

Click here to download the GPP2 Guidelines.

The landmark guidelines on Good Publication Practice (GPP) published in 2003 were developed with the aim of ensuring that “clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner.”

To address legislative, guidance, and ethical developments since 2003, and to reinforce the aims of the original document, the International Society for Medical Publication Professionals (ISMPP) convened a Steering Committee to develop a revised Good Publication Practice document to be known as “GPP2”. The committee’s work, GPP2, was independently peer reviewed and published in BMJ (2009;339:b4330).

GPP2 provides comprehensive guidance on a number of key issues, including:

• Roles of authors, sponsors, and other contributors
• Reimbursement and honoraria
• How to establish a publication steering committee
• Role of professional medical writers
• Recommendations for publication planning and documentation
 
Kind regards
IP Logged
Last Edited On: 2009-12-05 03:14:15 By GCP HelpDesk for the Reason
GCP HelpDesk
Page # 


Powered by ccBoard