SOCRA Certified Clinical Research Professional (CCRP) - CCRP FREE EXAM DUMPS QUESTIONS & ANSWERS

The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?

A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?

During an audit of a sponsor, the following documents and activities were reviewed: the protocol, applicable regulatory requirements, and compliance with Good Clinical Practice (GCP). What additional documents must be reviewed during the sponsor audit?

According to 21 CFR Part 11, each electronic signature must be unique and:

According to the ICH GCP Guidelines, what is the purpose of source documents?

A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator's proposed patient recruitment materials?

In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?

In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study. Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?