scholarly journals A review on selection of investigator in clinical trials

Author(s):  
Jyothi K Navya ◽  
Prameela Jogi ◽  
C.Randeep raj V

According to ICH GCP investigator may be considered as a person proficient in education, training, and experience who will take the major restraint for the good conduct of the trial and should satisfy all the requirements described by applicable regulatory authorities and must comply with GCP. Investigators are very much important for the primary conduct of the study, whose primary importance is to conduct research while protecting the rights, safety, and well-being of the participants. Investigators have many important roles in conducting ethical research, taking responsibility for the informed consent process, giving the statement of the investigator, checking of investigational product, reporting adverse events, maintaining accurate records. A selection of the investigator for the conduct of research is a complex process. Investigators should be selected based on their interest and their requirements for education, training, and experience. This can be done by assessing professional competency or through a referral from other investigators or through online databases or by advertising their CV on the internet. In multicenter trials selection is done by querying public and private, using databases, a referral from the clinical research team, performing a publication search. After the recruitment of Investigators, he will continue his activities like signing the investigators' form and perform the informed consent process, and finally enrollment of subjects. The Investigators involved in COVID-19 trials and the study type, recruitment status, purpose of the trial was collected. 

2019 ◽  
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M. Anderson

Author(s):  
Miraida Morales ◽  
Sarah Barriage

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.


2015 ◽  
Vol 6 (4) ◽  
pp. 31-43
Author(s):  
Kimberley N. Chapman ◽  
Eric Pevzner ◽  
Joan M. Mangan ◽  
Peter Breese ◽  
Dorcas Lamunu ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document