Asthmadrug1 Clinical Trial Risk Assessment Paper
Risk Assessment for the AsthmaDrug1 Clinical Trial.
Risk assessment is the process to identify areas of concern so an efficient response and an effective recovery plan can be placed if needed. In order to assess the potential risks a trial can face and to create a plan, six steps could be used: 1) Identify all the required Functions and Processes in the project; 2) Rank these identified functions and processes according to their “criticality”; 3) Determine the required time for recovery so the critical functions and processes can be maintained; 4) Identify those threats that could severely impact these critical functions and processes; 5) Determine the vulnerability of each critical project function and process; and 6) Identify and plan, …show more content…
The monitor needs to verify that the information recorded in the CRF is exactly matched with the data obtained from the source documents and every single conflicting data needs to be clarified ASAP.
Intellectual Property Rights: As defined by Arai, “Intellectual property refers to creations of the mind for which exclusive rights are recognized”. Intellectual property legislation stipulates that intellectual property owners are the owners of the exclusivity rights to commercially exploit an intangible asset. Intellectual property can be protected by having restricted access to the study information. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial (Ross …show more content…
Gallo, P., Chuang-Stein, C., Dragalin, V., et al. 2006. Adaptive design in clinical drug development - an executive summary of the PhRMA Working Group. Journal of Biopharmaceutical Statistics; 16(3): 275-283.
7. Iltis, A., S. 2009. Vulnerability in Biomedical Research. Journal of Law and Medical Ethics; 37 (1): 6-11.
8. Köpcke, F., Kraus, S., Scholler, A., et al. 2012. Secondary use of routinely collected patient data in a clinical trial: An evaluation of the effects on patient recruitment and data acquisition. International Journal of Medical Informatics; article in press.
9. Namiki, J., Yamazaki, M., Funabiki, T., et al. 2011. Inaccuracy and misjudged factors of Glasgow Coma Scale scores when assessed by inexperienced physicians. Clinical Neurology and Neurosurgery; 113(5): 393-8.
10. Ross, S., Magee, L., Walker, M., et al. 2012. Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact. Trials; 13(1): 243.
11. Williams, J., G., Cheung, W., Y., Cohen, D., R., et al. 2003. Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment. Health Technology Assessment; 7(26):
Risk assessment is the process to identify areas of concern so an efficient response and an effective recovery plan can be placed if needed. In order to assess the potential risks a trial can face and to create a plan, six steps could be used: 1) Identify all the required Functions and Processes in the project; 2) Rank these identified functions and processes according to their “criticality”; 3) Determine the required time for recovery so the critical functions and processes can be maintained; 4) Identify those threats that could severely impact these critical functions and processes; 5) Determine the vulnerability of each critical project function and process; and 6) Identify and plan, …show more content…
The monitor needs to verify that the information recorded in the CRF is exactly matched with the data obtained from the source documents and every single conflicting data needs to be clarified ASAP.
Intellectual Property Rights: As defined by Arai, “Intellectual property refers to creations of the mind for which exclusive rights are recognized”. Intellectual property legislation stipulates that intellectual property owners are the owners of the exclusivity rights to commercially exploit an intangible asset. Intellectual property can be protected by having restricted access to the study information. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial (Ross …show more content…
Gallo, P., Chuang-Stein, C., Dragalin, V., et al. 2006. Adaptive design in clinical drug development - an executive summary of the PhRMA Working Group. Journal of Biopharmaceutical Statistics; 16(3): 275-283.
7. Iltis, A., S. 2009. Vulnerability in Biomedical Research. Journal of Law and Medical Ethics; 37 (1): 6-11.
8. Köpcke, F., Kraus, S., Scholler, A., et al. 2012. Secondary use of routinely collected patient data in a clinical trial: An evaluation of the effects on patient recruitment and data acquisition. International Journal of Medical Informatics; article in press.
9. Namiki, J., Yamazaki, M., Funabiki, T., et al. 2011. Inaccuracy and misjudged factors of Glasgow Coma Scale scores when assessed by inexperienced physicians. Clinical Neurology and Neurosurgery; 113(5): 393-8.
10. Ross, S., Magee, L., Walker, M., et al. 2012. Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact. Trials; 13(1): 243.
11. Williams, J., G., Cheung, W., Y., Cohen, D., R., et al. 2003. Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment. Health Technology Assessment; 7(26):