How to write a surgical clinical research protocol: literature review and practical guide

Author:

Rosenthal Rachel,Schäfer Juliane,Briel Matthias,Bucher Heiner C.,Oertli Daniel,Dell-Kuster Salome

Publisher

Elsevier BV

Subject

General Medicine,Surgery

Reference70 articles.

1. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Ich Harmonised Tripartite Guideline: General Considerations for Clinical Trials: E8. Available at: http://www.ich.org/. Accessed January 30, 2013.

2. Medical device development: from prototype to regulatory approval;Kaplan;Circulation,2004

3. No surgical innovation without evaluation: the IDEAL recommendations;McCulloch;Lancet,2009

4. Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis;Heikens;Surg Innov,2013

5. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration;Boutron;Ann Int Med,2008

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