A review on selection of investigator in clinical trials

Authors

  • Jyothi K. Navya Pharm D, Vignan Institute of Pharmaceutical Technology, Visakhapatnam, Andhra Pradesh, India
  • Jogi Prameela Pharm D, Avanthi Institute of Pharmaceutical Sciences, Near Tagarapuvalasa Bridge, Vizayanagaram, Andhra Pradesh, India
  • V.C.Randeep raj Pharm D, Vignan Institute of Pharmaceutical Technology, Visakhapatnam, Andhra Pradesh, India

DOI:

https://doi.org/10.47957/ijpda.v9i3.481

Keywords:

clinical trials, investigator, selection, Covid-19

Abstract

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. 

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References

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Published

2021-10-04
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How to Cite

Navya, J. K., P. Jogi, and C. raj V. “A Review on Selection of Investigator in Clinical Trials”. International Journal of Pharmaceutics and Drug Analysis, vol. 9, no. 3, Oct. 2021, pp. 180-9, doi:10.47957/ijpda.v9i3.481.

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