DOES YOUR CLINICAL INVESTIGATOR UNDERSTAND THE CONSEQUENCES OF NON-COMPLIANCE?

2000 ◽  
Vol 7 (3) ◽  
pp. 135-145 ◽  
Author(s):  
Brian J. Donato ◽  
Thomas R. Gibson
2016 ◽  
Vol 39 (4) ◽  
pp. 140
Author(s):  
Norman D Rosenblum

The paper by Jones and colleagues, published in this edition of Clinical Investigative Medicine, contributes to our understanding of Canadian MD/PhD Programs. While there has been little published on this subject by the Canadian programs, themselves, this paper is the most recent in a series by leaders of the Clinical Investigator Trainee Association of Canada (CITAC). The authors are to be commended for their efforts and productivity.


2011 ◽  
Vol 34 (1) ◽  
pp. 105
Author(s):  
Mike Berger ◽  
Dominick Bosse ◽  
M Sara Kuruvilla ◽  
Pencilla Lang ◽  
Jean-Christophe Murray ◽  
...  

In 2010, the annual general meeting of the Clinical Investigator Trainee Association of Canada – Association des cliniciens-chercheurs en formation du Canada (CITAC-ACCFC) and the Canadian Society for Clinician Investigators (CSCI) was held between September 20 and 22 in Ottawa. Several globally-renowned scientists, including this year’s CSCI/Royal College Henry Friesen Award recipient, Dr. Paul Kubes, Distinguished Scientist Award recipient, Dr. Gideon Koren and Joe Doupe Young Investigator Award recipient, Dr. Torsten Neil, discussed a variety of topics relating to the role of technology in medicine. The meeting was well attended by clinician scientists and trainees from across Canada and offered trainees mentorship and networking opportunities in addition to showcasing their research at the young investigator forum. The aim of this scientific overview is to highlight the research presented by trainees at both the oral plenary session as well as the poster presentation sessions of this meeting. Similar to last year’s meeting [1], research questions being investigated by trainees covered the spectrum of medical disciplines, encompassing both basic science as well as clinical areas, and are summarized below. [1] Ong Tone, S., Dugani, S., Marshall, H., Shamji, M.F., Murray, J-C., and Bossé, D. 2010 Scientific overview of the CSCI-CITAC 2009 conference. Clin Invest Med 33: E69-72, E73-67


Author(s):  
Jorge Leite ◽  
Sandra Carvalho ◽  
Munir Boodhwani ◽  
Felipe Fregni

This chapter focuses on basic principles of survival analysis for the clinical investigator. Survival analysis is a specific type of standardized statistical analysis that focuses on assessing the time elapsed since the exposure/intervention to the occurrence of an event. Important concepts such as median survival time, cumulative probability of survival at specific time points by using Kaplan-Meier estimators, and the use of the use of log rank (Mantel–Cox) to compare survival functions are discussed. This chapter also discusses the concept of censoring, which happens when the event occurs outside the pre-specified time window, and how to develop hazard functions when there are several interrelated factors that can contribute to the increase or decrease of survival probability.


Author(s):  
Program Committee for Training Clinical Investigators

2019 ◽  
Vol 16 (3) ◽  
pp. 297-305
Author(s):  
Anna-Leena Saarela ◽  
Anja Walzer ◽  
Anne Mari Juppo

Background Interactive response technologies are used in clinical trials to provide services such as automated randomization and medication logistics management. The objective of this article is to investigate the usage of telephone (Interactive Voice Response) and web (Interactive Web Response) interfaces of interactive response technologies at clinical investigator sites in clinical trials, to obtain information about the preferences of interactive response technology end users between the telephone and web interfaces, and to explore the relevance of the telephone interface in this setting. Methods The data consist of an online survey conducted in spring 2016 with clinical investigators, study nurses, and pharmacists in 13 countries. Results Ninety-eight percent of survey respondents preferred the web interface over the telephone interface, the most important reason being superior usability. However, the respondents indicated the usability of interactive response technology interfaces is not optimal, and lack of integration and consistency across systems is common. A vast majority of interactive response technology end users at clinical sites prefer to use the web interface over the telephone interface, but most also feel there would need to be a back-up system. Conclusions Based on the results, it would be beneficial to improve the usability of the interactive response technology interfaces, and to increase consistency across systems from the current level. Support to and training of the users, as well as clarifying the responsibilities between sites and the sponsor should also be a focal point. Study sponsors should explore with interactive response technology service providers how removing the telephone interface would impact future studies, and whether there could be a more efficient means to achieve a reliable back-up to the web interface instead of a dedicated telephone interface.


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