The Role Of Crc And Cra In Study Initiation Process Case Study

Length: 2 pages Sources: 2 Subject: Health Type: Case Study Paper: #77374311 Related Topics: Biomedical, Clinical Research, Process, Special Education And Inclusion
Excerpt from Case Study :

Institutional Review Board Responsibilities at Study Initiation

Responsibilities of the IRB in the initiation of the trial

IRB is charged with the responsibility of protecting the safety and rights of participants in the clinical trial (Woodin and Schneider, 2008). Some IRB responsibilities like a trial investigator, monitoring, auditing research records and research participant education are likely to be shifted to special units under the Human Research Protection program (HRPP). Such responsibilities promote sponsor-investigator relationships promoting ethical and safe research practices. In the U.S., IRB also serves as the 1996 Health Insurance Portability and Accountability Act (HIPPA) privacy committee dealing with research-associated activities. IRB is especially useful for multicenter studies as it handles approving informed consent and protocol forms (Schultz, 2008). This makes meeting the regulatory requirements efficient. The responsibility of protecting human study participants is multifaceted. Belmont Report, Helsinki Declaration, and Nuremberg Code stipulate the underlying standards of protecting research subjects. IRB is charged with applying these standards in evaluating all aspects of the proposed study activities to ensure...


Concurrently, the IRB helps investigators in the upholding adherence to institutional policies and regulatory mandates.

IRB in the trial initiation process

The significance of IRB in the trial initiation process is to approve the initiation and periodically review the progress of biomedical studies engaging human participants. The IRB assists in ensuring that the trial initiation process is ethically sound. It considers whether risks to the study subjects are eliminated or reduced. Besides, the IRB considers whether the study staff and investigator have the appropriate training or experience co carry out trials properly (Woodin and Schneider, 2008).

Trial initiation processes must obtain approval from an IRB prior to signing up participants. When an investigator is interested in initiating a study that engages human subjects, including clinical trials, he/she should submit the research to the IRB for purposes of review. The Role of the IRB in the initiation phase is to review all components of the new research to ensure the welfare and rights of the human samples are secured (Schultz, 2008).

Furthermore, the IRB will assess the researcher's experience and training about the proposed research. This is, especially if the proposed research engages vulnerable subjects, higher risks and novel technologies. In such proposed studies, the IRB determines whether the researcher is qualified by reviewing his/her previous experiences as indicated by the prior study related…

Sources Used in Documents:


Schultz, J. (2008). Improving Subject Recruitment. Applied Clinical Trials, 17(3), 46-52. Retrieved from

Woodin, K. E., & Schneider, J. C. (2008). The CRA's Guide to Monitoring Clinical Research. Boston, MA: CenterWatch

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