19. questions to be raised to check a clinical trial protocol before carrying it out

2015 ◽  
pp. 222-230
Keyword(s):  
Clinical Trial ◽  
Trial Protocol ◽  
Clinical Trial Protocol

scholarly journals Intermittent fasting & performance: The iFast clinical trial protocol

2021 ◽  
pp. 100766
Author(s):  
Abbass El-Outa ◽  
Lara Ghandour ◽  
Hani Hamade ◽  
Cecile Borgi ◽  
Elie-Jacques Fares ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intermittent Fasting ◽  
Trial Protocol ◽  
Clinical Trial Protocol

scholarly journals Guidelines for randomized clinical trial protocol content: a systematic review

2012 ◽  
Vol 1 (1) ◽  
Author(s):  
Jennifer M Tetzlaff ◽  
An-Wen Chan ◽  
Jessica Kitchen ◽  
Margaret Sampson ◽  
Andrea C Tricco ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Protocol ◽  
Clinical Trial Protocol

scholarly journals Elements of a clinical trial protocol for medical devices

2017 ◽  
Vol 7 (6) ◽  
pp. 65
Author(s):  
Raymond P. Briggs ◽  
Lois Ramer
Keyword(s):  
Clinical Trial ◽  
Medical Device ◽  
De Novo ◽  
Evidence Based ◽  
Trial Protocol ◽  
Risk Class ◽  
Clinical Trial Protocol ◽  
Fda Approval ◽  
Near Future

Based on a Class 2 limited risk hospital based clinical trial, and a subsequent project retrospective, Briggs and Ramer propose an expanded clinical trial protocol.  Such an expanded protocol would be especially helpful for evaluating De Novo devices:  new inventions which require new processes for full hospital integration.  Since these new processes would often require training of nurses and supporting professionals, Briggs and Ramer suggest that nurse investigators could be very effective in carrying out such expanded protocol studies.  We briefly describe the FDA approval process, the role of the nurse in evidence based medical device evaluation, the Ramer, et al. clinical trial, the proposed expanded clinical trial protocol, and candidate categories of devices that might employ the limited risk Class 2 Medical Device clinical trial protocol.  The investigators look forward to carrying out such a medical device clinical trial in the near future.

scholarly journals Loose combined cutting seton for patients with suprasphincteric anal fistula: a randomized clinical trial protocol

2021 ◽  
Vol 10 (9) ◽  
pp. 10022-10030
Author(s):  
Yicheng Cheng ◽  
Lihua Zheng ◽  
Yuying Shi ◽  
Congcong Zhi ◽  
Jiaying Shan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Anal Fistula ◽  
Trial Protocol ◽  
Clinical Trial Protocol ◽  
Cutting Seton
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