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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.”1
To address legislative, guidance, and ethical developments since 2003,2,3 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
References
1. Wager E, Field EA, Grossman L. Good publication practice
for pharmaceutical companies. Curr Med Res Opin 2003;19:149-154.
2. Food and Drug Administration Amendments Act of 2007.
www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugand
CosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrug
AdministrationAmendmentsActof2007/default.htm.
3. International Committee of Medical Journal Editors.
Uniform requirements for manuscripts submitted to biomedical journals. www.icmje.org. |
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GPP2 GUIDELINES
ISMPP thanks BMJ for allowing the GPP2 guidelines to be posted here. |
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GPP2 WEBCAST
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ISMPP thanks BMJ for allowing the GPP2 guidelines to be posted here. |
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©2009 ISMPP. All Rights Reserved. |
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