Good Clinical Practice Quizzes- SET 1 questions with

Good Clinical Practice Quizzes- SET 1 questions with correct answers Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows).

• principal investigator
• sub-investigator
• study coordinator
• coordinating investigator CORRECT ANSWER b. sub-investigator

Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

• serious adverse event
• adverse drug reaction
• unexpected adverse drug reaction
• adverse event CORRECT ANSWER a. serious adverse event

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

• protocol
• clinical study report
• informed consent form
• audit report
• source data CORRECT ANSWER e. source data 1 / 2

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case or refusal to participate.

• sub-investigators
• coordinating investigators
• impartial witnesses
• vulnerable subjects
• investigators
• trial subjects CORRECT ANSWER d. vulnerable subjects

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

• informed consent forms
• monitoring reports
• case report forms
• audit certificates
• essential documents CORRECT ANSWER e. Essential documents

Individuals who participate in a clinical trial, either as recipients of the investigational product(s) or as controls

• trial subjects
• principal investigators
• coordinating investigators
• sub-investigators
• / 2