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Question 19/56
A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
Correct Answer: C
Unblinding procedures are aprotocol-level responsibilitybecause they involve trial design, safety management, and subject protection.
* ICH E6(R2) 6.0 (Protocol and amendments):Requires the protocol to specify "the treatment(s) and treatment periods, procedures for randomization and blinding, andprocedures for breaking codes."
* ICH E6(R2) 4.7:"The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol." The informed consent (A) explains risks and rights but does not include operational unblinding procedures.
The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.
Therefore, the correct answer isC (The study protocol), as it outlines unblinding steps and documentation requirements.
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §4.7 (Randomization and unblinding).
* ICH E6(R2) 6.0 (Protocol and amendments):Requires the protocol to specify "the treatment(s) and treatment periods, procedures for randomization and blinding, andprocedures for breaking codes."
* ICH E6(R2) 4.7:"The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol." The informed consent (A) explains risks and rights but does not include operational unblinding procedures.
The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.
Therefore, the correct answer isC (The study protocol), as it outlines unblinding steps and documentation requirements.
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §4.7 (Randomization and unblinding).
- 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...
