CCRP試験無料問題集「SOCRA Certified Clinical Research Professional (CCRP) 認定」

ページ: 1 / 15
トータル 132 問
完全版を入手する
On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?

解説: (GoShiken メンバーにのみ表示されます)
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

解説: (GoShiken メンバーにのみ表示されます)
What is included in the Statement of Investigator (Form FDA 1572)?

解説: (GoShiken メンバーにのみ表示されます)
A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?

解説: (GoShiken メンバーにのみ表示されます)
During the closeout visit, a monitor is completing the documentation of reconciliation of investigational product. All packaging, as well as the used and unused investigational product, are being returned to the sponsor for disposition. Which of the following documents wouldNOTbe required to be filed at the research site?

解説: (GoShiken メンバーにのみ表示されます)
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?

解説: (GoShiken メンバーにのみ表示されます)
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

解説: (GoShiken メンバーにのみ表示されます)
Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

解説: (GoShiken メンバーにのみ表示されます)
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?

解説: (GoShiken メンバーにのみ表示されます)
ページ: 1 / 15
トータル 132 問