A review on selection of investigator in clinical trials
Keywords:clinical trials, investigator, selection, Covid-19
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.
ICH Official web site : ICH. Ich.org. (2021). Retrieved 2 July 2021, from https://www.ich.org/page/efficacy-guidelines.
Maggon, K. (2004). Investigator and site selection and performing GCP clinical studies in India. Controlled Clinical Trials, 25(4), 366-377. https://doi.org/10.1016/j.cct.2004.06.006.
Lader, E., Cannon, C., Ohman, E., Newby, L., Sulmasy, D., & Barst, R. et al. (2004). The Clinician as Investigator. Circulation, 109(21), 2672-2679. https://doi.org/10.1161/01.cir.0000128702.16441.75
The Belmont Report. HHS.gov. (1987). Retrieved 14 July 2021, from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.
INVESTIGATOR. ICH GCP. (2021). Retrieved 14 July 2021, from https://ichgcp.net/4-investigator.
Baer, A., Devine, S., Beardmore, C., & Catalano, R. (2011). Clinical Investigator Responsibilities. Journal Of Oncology Practice, 7(2), 124-128. https://doi.org/10.1200/jop.2010.000216
Research Ethics & Compliance | University of Michigan. Research-compliance.umich.edu. (2021). Retrieved 14 July 2021, from https://research-compliance.umich.edu/.
Investigator Resources | CTEP. Ctep.cancer.gov. (2016). Retrieved 14 July 2021, from https://ctep.cancer.gov/investigatorresources/investigators_handbook.htm.
(2021). Retrieved 14 July 2021, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176043.htm.
CFR - Code of Federal Regulations Title 21. Accessdata.fda.gov. (2020). Retrieved 15 July 2021, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:22.214.171.124.3.4.
Fda.gov. (2010). Retrieved 15 July 2021, from http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf.
CFR - Code of Federal Regulations Title 21. Accessdata.fda.gov. (2021). Retrieved 15 July 2021, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50.
Feehan, A., & Garcia-Diaz, J. (2020). Investigator Responsibilities in Clinical Research. Ochsner Journal, 20(1), 44-49. https://doi.org/10.31486/toj.19.0085
Crossley, R. (1982). Project Planning, Investigator Selection, Data Harmonization. Drug Information Journal, 16(1-2), 35-43. https://doi.org/10.1177/009286158201600105
Lightfoot, G., Sanford, S., & Shefrin, A. (1999). Can Investigator Certification Improve the Quality of Clinical Research?. Quality Management In Health Care, 7(3), 31-36. https://doi.org/10.1097/00019514-199907030-00004
Holden, W. (1970). Specialty Board Certification as a Measure of Professional Competence. JAMA: The Journal Of The American Medical Association, 213(6), 1016. https://doi.org/10.1001/jama.1970.03170320044009
Hovde, M., & Seskin, R. (1997). Selecting U.S clinical investigators. Applied Clinical Trails. Retrieved 2 July 2021, from.
Bohdan, V. (2015). Investigator Selection for Multicenter Clinical Trials. Retrieved 2 July 2021, from.
Thoma, A., Haines, T., Duku, E., McKnight, L. and Goldsmith, C., 2008. How to Become a Successful Clinical Investigator. Clinics in Plastic Surgery, 35(2), pp.305-311.
Search of: investigator name | Covid19 - List Results - ClinicalTrials.gov. Clinicaltrials.gov. (2021). Retrieved 2 July 2021, from https://clinicaltrials.gov/ct2/results?cond=Covid19&term=investigator+name&cntry=&state=&city=&dist=.
How to Cite
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.