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Question 41/56
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
Correct Answer: C
* 21 CFR 56.109(a):IRBs must review all changes to informed consent before implementation.
* ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.
Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.
References:21 CFR 56.109(a); ICH E6(R2) §4.8.2.
* ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.
Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.
References:21 CFR 56.109(a); ICH E6(R2) §4.8.2.
- Question List (56q)
- Question 1: Which of the following statements about the investigator's b...
- Question 2: Which of the following statements about the initial IND appl...
- Question 3: Which of the following adverse events occurring during a stu...
- Question 4: Upon completion of a study, the investigator should do which...
- Question 5: According to ICH GCP, who besides the sponsor should approve...
- Question 6: Protecting prisoners' rights to voluntarily participate in r...
- Question 7: An approved investigational device exemption (IDE) permits a...
- Question 8: A Phase I clinical trial is initiating. Who is responsible f...
- Question 9: A Phase I study of a new blood pressure medication has been ...
- Question 10: In accordance with the CFR, which body must determine that a...
- Question 11: A revised protocol added genomic testing to banked tissue sa...
- Question 12: The sponsor withdrew an IND due to safety. Who must be notif...
- Question 13: Why would a Phase IV study be conducted?...
- Question 14: A clinical investigator terminated a Phase IV drug study. In...
- Question 15: On 15 May 2019, a sponsor announced that its investigational...
- Question 16: A physician wants to conduct research using an approved/mark...
- Question 17: In accordance with the CFR, for at least how many years afte...
- Question 18: During an IND study closeout, a monitor discovered remaining...
- Question 19: A study subject in a double-blinded, placebo-controlled Phas...
- Question 20: Which of the following is one of the responsibilities of an ...
- Question 21: According to ICH GCP, an electronic data capture (EDC) syste...
- Question 22: A subject has creatinine 1.6 mg/dL, slightly above eligibili...
- Question 23: In accordance with the ICH GCP Guideline, which of the follo...
- Question 24: When can an IRB/IEC review a study using expedited review?...
- Question 25: Which of the following is an adequate definition of quality ...
- Question 26: In accordance with the CFR, the sponsor (who is not a sponso...
- Question 27: In accordance with the CFR, which of the following statement...
- Question 28: Which case history documents must be at both sponsor and sit...
- Question 29: A sponsor's monitor is conducting a site selection visit for...
- Question 30: An investigator discovered a new serious unanticipated adver...
- Question 31: Which of the following is one of the responsibilities of an ...
- Question 32: In accordance with the Belmont Report, obtaining voluntary i...
- Question 33: A research assistant on a study was recently promoted to a c...
- Question 34: Which of the following entities, if any, must provide an app...
- Question 35: A nonrandomized study of 30 subjects entitled "A study to ev...
- Question 36: According to the CFR and the ICH GCP Guideline, which of the...
- Question 37: If a subject experiences a serious adverse event related to ...
- Question 38: When can the IRB/IEC require that additional information be ...
- Question 39: In accordance with 45 CFR 46, in addition to the Office for ...
- Question 40: A subject on a multi-drug regimen could not tolerate a non-i...
- Question 41: An investigator received an updated informed consent form (I...
- Question 42: What is included in the Statement of Investigator (Form FDA ...
- Question 43: A study team is preparing to initiate a Phase II trial for a...
- Question 44: For a Significant Risk device study, an investigator must re...
- Question 45: In accordance with the ICH GCP Guideline, at what intervals ...
- Question 46: The reviewing IRB/IEC determined that a minimal risk sponsor...
- Question 47: According to 21 CFR Part 11, each electronic signature must ...
- Question 48: During an audit of a sponsor, the following documents and ac...
- Question 49: An investigator is working with a new sponsor to submit a ca...
- Question 50: In accordance with ICH/GCP Guidance, how long should an IRB/...
- Question 51: In accordance with the ICH GCP Guideline, prior to initiatin...
- Question 52: A subject was instructed to do a glucose check 4 times a day...
- Question 53: A physician with 20 years of experience is planning to be th...
- Question 54: Sponsor must maintain drug disposition records for how long ...
- Question 55: A coordinator for an ongoing industry-sponsored, multi-site ...
- Question 56: A clinical investigator received an honorarium from the spon...
